OTC Active Ingredients
UNII Code 93NOD9WBCS 362O9ITL9D 362O9ITL9D 362O9ITL9D 362O9ITL9D SP86R356CC Q40Q9N063P Q40Q9N063P Q40Q9N063P Q40Q9N063P 1364PS73AF
18B8O9DQA2 18B8O9DQA2 18B8O9DQA2 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 3K9958V90M 8T66I31YNK SQI2NBY9KR SQI2NBY9KR 8C3Z4148WZ
344S277G0Z 344S277G0Z 344S277G0Z 344S277G0Z
Active Ingredient 2-ethylhexyl-4-phenylbenzophenone-2-carboxylic acid acetaminophen acetaminophen acetaminophen acetaminophen acetanilide acetic acid acetic acid acetic acid, glacial acetic acid, glacial acetone acidulated phosphate fluoride acidulated phosphate fluoride agar alcloxa alcloxa alcloxa alcohol alcohol alcohol alcohol alcohol alcohol alcohol alcohol alcohol alcohol alcohol alcohol, ethoxylated alkyl alcohol, ethoxylated alkyl aldioxa alfalfa alfalfa leaves alginic acid alkyl dimethyl amine oxide and alkyl dimethyl glycine alkyl isoquinolinium bromide alkyl isoquinolinium bromide allantoin allantoin allantoin allantoin (5-ureidohydantoin)
Monograph Sub-category sunscreen internal analgesic menstrual/diuretic analgesic nighttime sleep aid overindulgence in a hangover reliever internal analgesic otic wart remover corn/callus remover wart remover skin protectant astringent anticaries anticaries laxative bulk laxative acne anorectal keratolytic antifungal digestive aid external analgesic insect bite/sting external analgesic poison ivy/oak/sumac menstrual/diuretic mercury oral health care skin protectant astringent skin protectant insect bites/stings skin protectant poison ivy/oak/sumac skin protectant weight control external analgesic insect bite/sting skin protectant insect bites/stings skin protectant diaper rash weight control menstrual/diuretic weight control gingivitis/plaque acne dandruff dandruff external analgesic skin protectant corn/callus remover
April 7, 2010
Panel II I I II II
Pending IISE I
Final
IISE I IIS
FR Citation 58 FR 28281
54 FR 6826
310.545(a)(15)(i) III II III II
II I(e) III
III II
II
IIISE IIISE IIISE I I III II I(e) III
I II
310.545(a)(18)(ii) 355.10(a)(3)(i) 355.10(a)(3)(ii) 310.545(a)(12)(i) 310.545(a)(1) 346.20(a) 310.545(a)(22)(ii) 310.545(a)(8)(ii) 310.545(a)(10)(vi) 310.545(a)(10)(vii) 310.545(a)(24)(i)
I IIISE 310.545(a)(18)(ii) 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A) IISE II
IIISE II
II III III
[55 FR 33254] [55 FR 33254] [55 FR 33254]
III IIISE II III III IISE I IISE
310.545(a)(20) 310.545(a)(10)(vi) 310.545(a)(18)(v)(A) 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(1) 310.545(a)(7) 310.545(a)(7) 347.10(a) [55 FR 33261]
OTC Active Ingredients
UNII Code Active Ingredient 344S277G0Z allantoin (with aminobenzoic acid) 344S277G0Z allantoin (wound healing claims only) allyl isothiocyanate BN34FX42G3 allyl isothiocyanate BN34FX42G3 allyl isothiocyanate BN34FX42G3 almadrate sulfate 9104833TPA V5VD430YW9, ZY8aloe ingredients (aloe, aloe extract, aloe flower extract) 09TD8L5SQV aloe vera [see aloe] V5VD430YW9 aloes W41H6S09F4 aloin alpha cellulose alum, ammonium DPU64XYB1D alum, ammonium DPU64XYB1D alum, potassium 1L24V9R23S alum, potassium 1L24V9R23S alum, potassium 1L24V9R23S alum, potassium 1L24V9R23S alumina powder, hydrated LMI26O6933 80EHD8I43D aluminum acetate 80EHD8I43D aluminum acetate 80EHD8I43D aluminum acetate aluminum bromohydrate aluminum carbonate gel (basic) aluminum chlorhydroxy complex LIF1N9568Y aluminum chloride (alcoholic solutions) LIF1N9568Y aluminum chloride (aqueous solution) (aerosol only) LIF1N9568Y aluminum chloride (nonaerosol aqueous solution) LIF1N9568Y aluminum chloride hexahydrate aluminum chlorohydrate HPN8MZW13M aluminum chlorohydrex aluminum chlorohydrex polyethylene glycol aluminum chlorohydrex propylene glycol aluminum dichlorohydrate aluminum dichlorohydrex polyethylene glycol aluminum dichlorohydrex propylene glycol 5QB0T2IUN0 aluminum hydroxide 5QB0T2IUN0 aluminum hydroxide 5QB0T2IUN0 aluminum hydroxide 5QB0T2IUN0 aluminum hydroxide 5QB0T2IUN0 aluminum hydroxide 5QB0T2IUN0 aluminum hydroxide
Monograph Sub-category sunscreen skin protectant cough/cold nasal decongestant external analgesic counterirritant external analgesic fever blister/cold sore digestive aid antacid laxative stimulant laxative gingivitis/plaque menstrual/diuretic laxative stimulant laxative laxative bulk laxative oral health care astringent skin protectant astringent antifungal antiperspirant oral health care skin protectant astringent antidiarrheal external analgesic skin protectant astringent skin protectant diaper rash antiperspirant antacid skin protectant astringent antiperspirant antiperspirant antiperspirant external analgesic antiperspirant acne antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant acne antacid antidiarrheal digestive aid antacid overindulgence in a hangover reliever skin protectant diaper rash
April 7, 2010
Panel II
I III
I II III IIISE II III I IISE II IIS I I II I I I I I II
III
Pending IIIE III I II I I IIIE III III I III IIISE I
Final 310.545(a)(18)(i)(A) 310.545(a)(6)(ii)(A) pending 310.545(a)(10)(v) 310.545(a)(12)(iv)(C) 310.545(a)(24)(i) 310.545(a)(12)(iv)(A)
310.545(a)(18)(ii) 310.545(a)(22)(ii) 310.545(a)(4)(i) 310.545(a)(18)(ii)
III I I IIISE IISE I IIS I IIIE I II I I I I I II I I I
347.12(a) 347.12(a) 310.545(a)(4)(i) 331.11(a)(1) 310.545(a)(18)(ii) 310.545(a)(4)(i) 310.545(a)(4)(i) 350.10(a) 350.10(b) 310.545(a)(1) 350.10(c) 350.10(d) 350.10(e) 350.10(f) 350.10(g) 310.545(a)(1) 331.11(a)(2) 310.545(a)(3)(i) 310.545(a)(8)(ii) 310.545(a)(18)(iii)
FR Citation 58 FR 28281
OTC Active Ingredients
UNII Code 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 5QB0T2IUN0 F92V3S5210 F92V3S5210 UCN889409V
34S289N54E 34S289N54E I7T908772F 481Y8HDW2B P9D3YP29MY 15K31617MU 94703016SM 8O386558JE 8O386558JE T27D6T99LH T27D6T99LH 376KTP06K8 OR5RM3Q5QL TE7660XO1C TL2TJE8QTX TL2TJE8QTX 27Y3KJK423 5138Q19F1X 5138Q19F1X JD546Z56F0 R0JB3224WS R0JB3224WS R0JB3224WS R0JB3224WS R0JB3224WS
Active Ingredient aluminum hydroxide aluminum hydroxide aluminum hydroxide gel aluminum hydroxide gel aluminum hydroxide gel aluminum hydroxide-hexitol, stabilized polymer aluminum hydroxide-magnesium carbonate, co-dried gel aluminum hydroxide-magnesium trisilicate, co-dried gel aluminum hydroxide-sucrose powder hydrated aluminum phosphate aluminum phosphate gel (in combination only) aluminum sesquichlorohydrate aluminum sesquichlorohydrate poylethylene glycol aluminum sesquichlorohydrate propylene glycol aluminum sulfate aluminum sulfate aluminum sulfate buffered w/ sodium aluminum lactate aluminum sulfate, anhydrous aluminum sulfate, buffered (aerosol only) aluminum zirconium octachlorohydrate aluminum zirconium octachlorohydrex gly aluminum zirconium pentachlorohydrate aluminum zirconium pentachlorohydrex gly aluminum zirconium tetrachlorohydrate aluminum zirconium tetrachlorohydrex gly aluminum zirconium trichlorohydrate aluminum zirconium trichlorohydrex gly amiloxate (isoamyl p-methoxycinnamate) aminacrine hydrochloride aminoacetic acid aminobenzoic acid aminobenzoic acid (PABA) aminophylline ammonia solution, strong ammonia solution, strong (ammonia water, strong) ammoniated mercury ammonium bromide ammonium chloride ammonium chloride ammonium chloride ammonium chloride
Monograph Sub-category skin protectant diaper rash topical analgesic diaper rash anorectal protectant overindulgence in a hangover reliever skin protectant antacid antacid antacid antacid antacid antacid antiperspirant antiperspirant antiperspirant antifungal antiperspirant antiperspirant w/ sales less than $25,000 skin protectant astringent antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant antiperspirant sunscreen boil treatment antiemetic internal analgesic sunscreen cough/cold bronchodilator skin protectant insect bites/stings external analgesic fever blister/cold sore antimicrobial first aid antiseptic nighttime sleep aid bromide cough/cold expectorant menstrual/diuretic diuretic nighttime sleep aid oral health care expectorant
April 7, 2010
Panel
Pending
I(e,i)
I(e,i) I I I I I I I I I I I
I
I I I IIISE I I I I I I I I I I I NA
IIISE IIIS I IIIS IIS IIS IIS IIS IIS IIS IIS IIS
II I I
IISE II II I II
I
I
II
IISE III I II
I III
Final 310.545(a)(18)(iii) 310.545(a)(10)(iv) 346.14(a)(1)
FR Citation
347.10(b) 331.11(a)(2) 331.11(a)(2) 331.11(a)(2) 331.11(a)(2) 331.11(i)(1) 331.11(a)(4) 350.10(h) 350.10(i) 350.10(j) 310.545(a)(22)(ii) 310.545(a)(4)(i) 310.545(a)(4)(ii) 347.12(b) 310.545(a)(4)(i) 350.10(k) 350.10(l) 350.10(m) 350.10(n) 350.10(o) 350.10(p) 350.10(q) 350.10(r) 310.531(a) 310.545(a)(23)(i) 352.10(a) 310.545(a)(6)(iv) 310.545(a)(18)(v)(A) 310.545(a)(10)(v) 310.545(a)(27)(i) [54 FR 6826] 310.545(a)(6)(iii)
OTC Active Ingredients
UNII Code R0JB3224WS 5138Q19F1X YOJ58O116E
6Y89129C8H 21C2F5E8RE DL6OZ476V3 T3CHA1B51H T3CHA1B51H T3CHA1B51H 7C0697DR9I 7C0697DR9I GN83C131XS GN83C131XS 94ZLA3W45F
W9FZA51AS1 Y62M9GTW4A PQ6CK8PD0R PQ6CK8PD0R PQ6CK8PD0R Z1EJP3037Z Q6Z8UK5R3G R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E R16CO5Y76E
Active Ingredient Monograph Sub-category ammonium chloride stimulant ammonium hydroxide skin protectant insect bites/stings amylase digestive aid antifungal amyltricresols, secondary oral health care amyltricresols, secondary anion and cation exchange resins buffered skin protectant poison ivy/oak/sumac anise oil weight control anise seed digestive aid antimony potassium tartrate cough/cold expectorant antipyrine internal analgesic antipyrine ophthalmic anesthetic antipyrine oral health care anesthetic/analgesic any atropine ingredient internal analgesic any atropine ingredient menstrual/diuretic any ephedrine ingredient internal analgesic any ephedrine ingredient menstrual/diuretic arginine weight control aromatic powder digestive aid aromatics skin protectant astringent asafetida digestive aid asclepias tuberosa menstrual/diuretic botanical/vegetable herb ascorbic acid corn/callus remover ascorbic acid wart remover ascorbic acid weight control asparagus menstrual/diuretic aspergillus oryza enzymes (except lactase enzyme derived from aspe digestive aid aspirin external analgesic analgesic & anesthetic aspirin external analgesic fever blister/cold sore aspirin external analgesic poison ivy/oak/sumac aspirin internal analgesic cardiovascular aspirin internal analgesic rheumatologic aspirin menstrual/diuretic analgesic aspirin nighttime sleep aid aspirin oral health care anesthetic/analgesic aspirin overindulgence in a hangover reliever aspirin (buffered) internal analgesic cardiovascular aspirin (buffered) internal analgesic rheumatologic aspirin, aluminum internal analgesic aspirin, calcium internal analgesic aspirin, calcium internal analgesic aspirin, calcium menstrual/diuretic
April 7, 2010
Panel
III
Pending IIE
III IIISE II
III II II
II III II II
II II II II III
III III III I I II I I I III
II IISE IIIE II
III III III I I I IIE IIIE I I I III I I I
Final
FR Citation [39 FR 6104]
310.545(a)(18)(v)(A) 310.545(a)(8)(ii) 310.545(a)(22)(ii) 310.545(a)(18)(vi)(A) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(6)(iii) 310.545(a)(23)(i) 310.545(a)(21)(i) 310.545(a)(14) 310.545(a)(23)(ii) 310.545(a)(24)(ii) 310.545(a)(23)(ii) 310.545(a)(24)(ii) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(18)(ii) 310.545(a)(8)(ii) 310.545(a)(24)(i) [55 FR 33261] [55 FR 33254] 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(8)(ii) 310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 343.12(a) 343.13(a) [54 FR 6826]
343.12(b) 343.13(b) 310.545(a)(23)(i)
OTC Active Ingredients
UNII Code WQZ3G9PF0H 7C0697DR9I 03J5ZE7KA5 03J5ZE7KA5 U6V729APAM G63QQF2NOX 58H6RWO52I 89Y4M234ES 5P5C03819W 8WB9PV3YW5 3M5V3D1X36 3M5V3D1X36 3M5V3D1X36 2ZA36H0S2V 2ZA36H0S2V 2ZA36H0S2V WQZ3G9PF0H WQZ3G9PF0H WQZ3G9PF0H WQZ3G9PF0H WQZ3G9PF0H 6GZW20TIOI PWZ1720CBH F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 F5UM2KM3W7 PH41D05744 PH41D05744 PH41D05744
Active Ingredient atropa belladonna atropine atropine sulfate atropine sulfate attapulgite, activated avobenzone bacillus acidophilus bacitracin bacitracin zinc barosma basic fuchsin beachwood creosote bean bearberry bearberry (extract of uva ursi) bearberry fluidextract (extract of bearberry) beeswax beeswax beeswax belladonna alkaloids belladonna alkaloids belladonna alkaloids belladonna alkaloids belladonna extract belladonna leaves, powdered exrtact bemotrizinol benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzethonium chloride benzethonium chloride benzethonium chloride
Monograph Sub-category Panel Pending cough/cold anticholinergic II anorectal anticholinergic II(e,i) II(e,i) antidiarrheal III III cough/cold anticholinergic III antidiarrheal w/ sales less than $25,000 III I sunscreen digestive aid first aid antibiotic ointment I first aid antibiotic ointment I menstrual/diuretic antifungal III III cough/cold expectorant III digestive aid weight control II menstrual/diuretic menstrual/diuretic skin protectant insect bites/stings w/ sales less than $25,000 skin protectant poison ivy/oak/sumac w/ sales less than $25,000 skin protectant w/ sales less than $25,000 corn/callus remover II IISE cough/cold anticholinergic IIIE cough/cold bronchodilator II II digestive aid anorectal anticholinergic II(e,i) II(e,i) digestive aid sunscreen NA antimicrobial I antimicrobial I antimicrobial IIISE antimicrobial IIISE antimicrobial IIISE antimicrobial IIISE antimicrobial IIISE antimicrobial IISE dandruff III III external analgesic insect bite/sting skin protectant astringent II skin protectant insect bites/stings antifungal antimicrobial I antimicrobial IIIE
April 7, 2010
Final 310.53 310.545(a)(26)(i) 310.545(a)(3)(i) 310.53 310.545(3)(ii) 352.10(a) 310.545(a)(8)(ii) 333.110(a) 333.110(b) 310.545(a)(24)(i) 310.545(a)(22)(ii) 310.545(a)(6)(iii) 310.545(a)(8)(ii) 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B)
FR Citation
[55 FR 33261] 310.53 310.545(a)(6)(iv) 310.545(a)(8)(ii) 310.545(a)(26)(i) 310.545(a)(8)(ii)
310.545(a)(7) 310.545(a)(10)(vi) 310.545(a)(18)(ii) 310.545(a)(18)(v)(A) 310.545(a)(22)(ii)
OTC Active Ingredients
UNII Code PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 PH41D05744 U3RSY48JW10 U3RSY48JW11 U3RSY48JW12 U3RSY48JW13 U3RSY48JW14 U3RSY48JW15 U3RSY48JW16 U3RSY48JW17 U3RSY48JW18 U3RSY48JW19 U3RSY48JW5 U3RSY48JW5 U3RSY48JW6 U3RSY48JW7 U3RSY48JW9 8SKN0B0MIM 8SKN0B0MIM 8SKN0B0MIM 8SKN0B0MIM L7J6A1NE81 L7J6A1NE81 5P4DHS6ENR GRE0P19C3Z W9WZN9A0GM LKG8494WBH LKG8494WBH LKG8494WBH LKG8494WBH LKG8494WBH LKG8494WBH LKG8494WBH LKG8494WBH
Active Ingredient Monograph Sub-category benzethonium chloride antimicrobial benzethonium chloride antimicrobial benzethonium chloride antimicrobial benzethonium chloride antimicrobial benzethonium chloride antimicrobial benzethonium chloride dandruff benzethonium chloride external analgesic poison ivy/oak/sumac benzethonium chloride skin protectant astringent benzethonium chloride skin protectant poison ivy/oak/sumac benzocaine external analgesic benzocaine oral health care anesthetic/analgesic benzocaine otic benzocaine pediculicide benzocaine relief of oral discomfort benzocaine relief of oral discomfort benzocaine skin protectant astringent benzocaine skin protectant poison ivy/oak/sumac benzocaine wart remover benzocaine weight control benzocaine acne benzocaine external analgesic male genital desensitizer benzocaine anorectal local anesthetic benzocaine dandruff benzocaine (0.5 - 1.25%) external analgesic poison ivy/oak/sumac benzoic acid acne benzoic acid antifungal benzoic acid oral health care benzoic acid skin protectant astringent expectorant benzoin preparations (compound tincture of benzoin, tincture of benz cough/cold benzoin tincture, compound relief of oral discomfort benzonatate cough/cold antitussive benzoxiquine antifungal benzoyl peroxide acne benzyl alcohol anorectal local anesthetic benzyl alcohol external analgesic analgesic & anesthetic benzyl alcohol external analgesic male genital desensitizer benzyl alcohol oral health care anesthetic/analgesic benzyl alcohol pediculicide benzyl alcohol relief of oral discomfort benzyl alcohol relief of oral discomfort benzyl alcohol skin protectant poison ivy/oak/sumac
April 7, 2010
Panel
III
Pending IIISE IIISE IIISE IIISE IISE III
II
I II
IIIE I IISE II I IIIE
II II II I I(e),III(i) II I II III
I II
FR Citation
310.545(a)(7) 310.545(a)(10)(vii) 310.545(a)(18)(ii) 310.545(a)(18)(vi)(A) IISE (0.5-1.25%) [51 FR 28660] 310.545(a)(25)(i)
310.545(a)(18)(ii) 310.545(a)(18)(vi)(A) IISE IISE II I I(e),III(i) IIE I II III IIIE
II
III I III(e,i) I
Final
III I I III I-> IIIS I(e),III(i) I I II I IIISE
[55 FR 33254] 310.545(a)(1) 348.10(a)(1) 346.10(a) [56 FR 63567] 310.545(a)(10)(vii) 310.545(a)(1) 310.545(a)(22)(ii) 310.545(a)(18)(ii) 310.545(a)(6)(iii)
310.545(a)(22)(ii) 333.310(a) 346.10(b) Pending 310.545(a)(10)(iii) 310.545(a)(25)(i)
310.545(a)(18)(vi)(A)
75 FR 9767
OTC Active Ingredients
UNII Code N863NB338G JK8U8K4D6K
6SO6U10H04 10X0709Y6I JB5Y63JDHJ M41L2IN55T A6I4E79QF1
M41L2IN55T M41L2IN55T M41L2IN55T YIW503MI7V YIW503MI7V YIW503MI7V YIW503MI7V H19J064BA5 YIW503MI7V YIW503MI7V YIW503MI7V YIW503MI7V YIW503MI7V YIW503MI7V YIW503MI7V YIW503MI7V 62TEY51RR1 62TEY51RR2 62TEY51RR3 62TEY51RR4 62TEY51RR5 8NT850T0YS AMT77LS62O AMT77LS62O 86R5J6D01D 6L5ZL09795 6L5ZL09795 R57ZHV85D10 R57ZHV85D11
Active Ingredient benzyl benzonate betaine hydrochloride bicarbonate bile salts/acids biotin bisacodyl bismuth aluminate bismuth carbonate bismuth oxide bismuth sodium tartrate bismuth sodium tartrate bismuth subcarbonate bismuth subcarbonate bismuth subcarbonate bismuth subgallate bismuth subgallate bismuth subgallate bismuth subgallate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subnitrate bismuth subsalicylate bismuth subsalicylate bismuth subsalicylate bismuth subsalicylate bismuth subsalicylate bisoctrizole bithionol bithionol black radish powder blessed thistle (cnicus benedictus) blessed thistle (cnicus benedictus) bone marrow, red boric acid boric acid
Monograph Sub-category pediculicide digestive aid antacid laxative stimulant laxative weight control laxative antacid antacid anorectal protectant digestive aid external analgesic fever blister/cold sore anorectal protectant antacid digestive aid anorectal protectant antacid deodorants for internal use digestive aid skin protectant anorectal protectant antacid antidiarrheal w/ sales less than $25,000 skin protectant fever blister/cold sore skin protectant insect bites/stings w/ sales less than $2 skin protectant poison ivy/oak/sumac poison ivy/oak/sumac w/ sales less than skin protectant skin protectant w/ sales less than $25,000 antidiarrheal antiemetic antimicrobial oral health care overindulgence in a overindulgence sunscreen external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac digestive aid digestive aid menstrual/diuretic weight control skin protectant fever blister/cold sore skin protectant insect bites/stings w/ sales less than $2
April 7, 2010
Panel II
Pending II
III(e,i) II
III II I I I III(e,i) II
III(e,i)
III(e,i) I
III(e,i)
III(e,i) I I
III II II(e,i) III II II II II III
IIS II(e,i) I III II II II II II IIIE III IISE IISE I
Final 310.545(a)(25)(i) 310.545(a)(8)(ii) 331.11(b) 310.545(a)(12)(iv)(A) 310.545(a)(20) 331.11(c)(1) 331.11(c)(2) 310.545(a)(26)(viii) 310.545(a)(8)(i) 310.545(a)(10)(v) 310.545(a)(26)(viii) 331.11(c)(3) 310.545(a)(8)(ii) 310.545(a)(26)(viii) 331.11(c)(4) 357.810(a) 310.545(a)(8)(ii) 310.545(a)(26)(viii) 331.11(c)(5) 310.545(a)(3)(ii) 310.545(a)(18)(iv) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 335.10(a)
NA
II
II II II
310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(18)(iv) 310.545(a)(18)(v)(B)
FR Citation
OTC Active Ingredients
UNII Code R57ZHV85D12 R57ZHV85D13 R57ZHV85D14 R57ZHV85D4 R57ZHV85D5 R57ZHV85D6 R57ZHV85D7 R57ZHV85D8 R57ZHV85D9 LU86E5P72A
IXA7C9ZN03 KOS935A04V KOS935A04V KOS935A04V 2C5Q57D7Z4 PAU39W3CVB PAU39W3CVB 3G6A5W338E 3G6A5W338E 3G6A5W338E 3G6A5W338E 3G6A5W338E 3G6A5W338E 3G6A5W338E 3G6A5W338E U26EO4675Q
SY7Q814VUP Y882YXF34X H0G9379FGK H0G9379FGK
Active Ingredient boric acid boric acid boric acid boric acid boric acid boric acid boric acid boric acid boric acid bornelone (5-(3,3-dimethyl-2-norbornyliden)3-pentene-2-one) bornyl acetate (topical) boroglycerin boroglycerin bran brompheniramine maleate buchu buchu powdered extract (extract of buchu) buchu, potassium extract buckthorn butacaine sulfate butacaine sulfate butamben picrate caffeine caffeine caffeine caffeine caffeine caffeine caffeine caffeine caffeine citrate calamine calamine calamine calamine calamine (in combination only) calcium calcium (mono or dibasic salt) calcium acetate calcium carbonate calcium carbonate
Monograph Sub-category skin protectant poison ivy/oak/sumac skin protectant poison ivy/oak/sumac w/ sales less than skin protectant w/ sales less than $25,000 acne anorectal antiseptic antifungal dandruff ophthalmic anti-infective skin protectant astringent sunscreen cough/cold nasal decongestant anorectal antiseptic oral health care laxative cough/cold antihistamine weight control menstrual/diuretic weight control digestive aid relief of oral discomfort relief of oral discomfort external analgesic cough/cold miscellaneous internal analgesic menstrual/diuretic analgesic menstrual/diuretic diuretic nighttime sleep aid stimulant overindulgence in a hangover reliever stimulant weight control weight control anorectal astringent external analgesic insect bite/sting external analgesic poison ivy/oak/sumac skin protectant anorectal protectant weight control antacid skin protectant astringent antacid digestive aid antacid
April 7, 2010
Panel II II II II II(e,i) III II III II III III II(e,i)
I II
I III III I
I(e,i)
I I(e,i)
Pending II II II II II(e,i) II II II IIIE III II(e,i) IISE I I II II II
I I I I II II I(e,i)
I I(e,i) II
I I
FR Citation
58 FR 28281 310.545(a)(6)(ii)(B) 310.545(a)(26)(ii)
341.12(a) 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(8)(ii)
I IIISE I IIIE IIIE
II III
Final 310.545(a)(18)(vi)(A) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(1) 310.545(a)(26)(ii) 310.545(a)(22)(ii) 310.545(a)(7) 310.545(a)(21)(ii) 310.545(a)(18)(ii)
340.10 310.545(a)(20) 310.545(a)(20) 346.18(a) 310.545(a)(10)(vi) 310.545(a)(10)(vii) 347.10(c) 346.14(b)(1) 310.545(a)(20) 331.11(i)(2) 310.545(a)(18)(ii) 331.11(d) 310.545(a)(8)(i)
OTC Active Ingredients
UNII Code H0G9379FGK H0G9379FGK SQE6VB453K PF5DZW74VN 2URQ2N32W3 2URQ2N32W3 568ET80C3D 568ET80C3D 568ET80C3D 568ET80C3D H0G9379FGK
210100728E 77YW1RTU8V 77YW1RTU8V 77YW1RTU8V J2D46N657D J2D46N657D 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET 5TJD82A1ET
Active Ingredient calcium carbonate calcium carbonate precipitated calcium caseinate calcium gluconate calcium hydroxide calcium lactate calcium lactate calcium pantothenate calcium pantothenate calcium pantothenate calcium pantothenate calcium phosphate calcium polycarbophil calcium polycarbophil calcium polysuldfide calcium salicylate calcium sucrose phosphate calcium thiosulfate calcium undecylenate calcium undecylenate calcium undecylenate calomel calomel (mercurous chloride) camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor camphor (exceding 3 percent)
Monograph Sub-category weight control antidiarrheal weight control digestive aid antidiarrheal w/ sales less than $25,000 menstrual/diuretic weight control laxative stimulant laxative menstrual/diuretic wart remover weight control antacid antidiarrheal w/ sales less than $25,000 laxative bulk laxative acne internal analgesic anticaries acne antifungal antimicrobial dandruff laxative stimulant laxative antimicrobial first aid antiseptic acne anorectal analgesic, anesthetic, antipruritic counterirritant anorectal antifungal cough/cold antitussive cough/cold antitussive cough/cold expectorant cough/cold nasal decongestant external analgesic external analgesic oral health care anesthetic/analgesic oral health care non-antimicrobal relief of oral discomfort skin protectant insect bites/stings skin protectant poison ivy/oak/sumac sunscreen wart remover external analgesic fever blister/cold sore
April 7, 2010
Panel III
III
Pending II III II III II III
III
NC II II II I
IIIE II I I I II NC II I IIISE II
II II(e,i) II III III III I I II
II I(e) II(e,i) II IIIE I III IIIE I IISE IISE
Final 310.545(a)(20) 310.545(a)(3)(i) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(3)(ii) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(12)(iv)(A) 310.545(a)(24)(i)
FR Citation
[55 FR 33254] 310.545(a)(20) 331.11(d) 310.545(a)(3)(ii) 310.545(a)(1) 310.545(a)(23)(i) 310.545(a)(2)(ii) 310.545(a)(1) 333.210(f) 310.545(a)(7) 310.545(a)(12)(iv)(A) 310.545(a)(27)(i) 310.545(a)(1) 346.16(a) 310.545(a)(26)(iv) 310.545(a)(22)(ii) 341.14(b)(1) 341.14(b)(1) 310.545(a)(6)(iii)
steam inhalation topical topical/inhalant [59 FR 43408]
310.545(a)(14) IISE 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A) inactive II I
IISE I
43 FR 38208 [55 FR 33254] 310.545(a)(10)(v)
OTC Active Ingredients
UNII Code 5TJD82A1ET 5TJD82A1ET
S07O44R1ZM S07O44R1ZM S07O44R1ZM S07O44R1ZM S07O44R1ZM S07O44R1ZM S07O44R1ZM S07O44R1ZM 09TQU5PG95 31PZ2VAU81 31PZ2VAU81 31PZ2VAU81 31PZ2VAU81 N667F17JP1 N667F17JP1 4SH0MFJ5HJ 2P3VWU3H10 142M471B3J K679OBS311 K679OBS311 K679OBS311 K679OBS311 5C69YCD2YJ 5C69YCD2YJ 5C69YCD2YJ
4VBP01X99F
D5340Y2I9G D5340Y2I9G
Active Ingredient camphor (lozenge) camphor gum camphorated metacresol camphorated metacresol camphorated metacresol candicidin capsaicin capsicum capsicum capsicum capsicum capsicum oleoresin capsicum oleoresin capsicum, fluid extract of carbon captan caramiphen edisylate carbamide peroxide carbamide peroxide carbamide peroxide (in anhydrous glycerin) carbamide peroxide 6.5% (in anhydrous glycerin) carbaspirin calcium carbaspirin calcium carbetapentane citrate carbon carbon dioxide, released carboxymethylcellulose sodium carboxymethylcellulose sodium carboxymethylcellulose sodium carboxymethylcellulose sodium carrageenan carrageenan (degraded) carrageenan (native) casanthranol cascara fluidextract aromatic cascara fluidextract, aromatic (extract of cascara) cascara sagrada bark cascara sagrada extract cascara sagrada extract cascara sagrada fluidextract castor oil castor oil
Monograph Sub-category cough/cold nasal decongestant skin protectant astringent antifungal external analgesic analgesic & anesthetic external analgesic male genital desensitizer antifungal external analgesic fever blister/cold sore digestive aid external analgesic fever blister/cold sore relief of oral discomfort relief of oral discomfort external analgesic fever blister/cold sore menstrual/diuretic digestive aid dandruff cough/cold antitussive oral health care oral health care oral health care wound cleansing otic internal analgesic menstrual/diuretic analgesic cough/cold antitussive digestive aid laxative antidiarrheal laxative ophthalmic demulcents weight control weight control laxative bulk laxative laxative bulk laxative laxative stimulant laxative laxative stimulant laxative menstrual/diuretic laxative stimulant laxative digestive aid laxative stimulant laxative laxative stimulant laxative laxative stimulant laxative wart remover
April 7, 2010
Panel III II III IIISE
Pending III
II I
II I
I
I IIIE IISE I
I
III III
I I I III
III I
III IIIE III IIIE I I I
Final 310.545(a)(6)(ii)(A) 310.545(a)(18)(ii) 310.545(a)(22)(iv) Pending 310.545(a)(10)(iii) 310.545(a)(22)(ii) 310.545(a)(10)(v) 310.545(a)(8)(ii) 310.545(a)(10)(v)
FR Citation
310.545(a)(10)(v) 310.545(a)(24)(i) 310.545(a)(8)(ii) 310.545(a)(7) [52 FR 30054]
344.10
IIIE
[52 FR 30054]
I 310.545(a)(3)(i) I
I I III III II III I I I
II
I I I IISE
349.12(a)(1) 310.545(a)(20) 310.545(a)(20) 310.545(a)(12)(i) 310.545(a)(12)(i) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(C) 310.545(a)(24)(i) 310.545(a)(12)(iv)(C) 310.545(a)(8)(ii) 310.545(a)(12)(iv)(C) 310.545(a)(12)(iv)(C) [55 FR 33254]
OTC Active Ingredients
UNII Code 483O0360NZ 7Y51EV0DZW BJ169U4NLG SMD1X3XO9M 85474O1N9D 85474O1N9D 936JST6JCN 936JST6JCN 936JST6JCN D9OM4SK49P O2T154T6OG 2P3VWU3H10 2P3VWU3H10 2P3VWU3H10 2P3VWU3H10 2P3VWU3H10 2P3VWU3H10 2P3VWU3H10 69QQ58998Y 418M5916WG 418M5916WG 418M5916WG 418M5916WG 418M5916WG NPB7A7874U BPF36H1G6S HM4YQM8WRC HM4YQM8WRC HM4YQM8WRC HM4YQM8WRC 7V31YC746X 7V31YC746X CIW5S16655
LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT
Active Ingredient catechu, tinctures catnip cedar leaf oil (topical) cellulase cellulose, microporous cetalkonium chloride cetalkonium chloride cetyl alcohol cetyl alcohol cetyl alcohol cetylpyridinium chloride chamomile flowers charcoal (activated) charcoal, activated Charcoal, activated charcoal, activated charcoal, activated charcoal, activated charcoal, wood/activated chlophedianol hydrochloride chloral hydrate chloral hydrate chloral hydrate chloral hydrate chloral hydrate chlorcyclizine hydrochloride chlorhydroxyquinoline (cloxyquin) chlorobutanol chlorobutanol chlorobutanol chlorobutanol chloroform chloroform chlorophenothane (dichlorodiphenyl trichloroethane) chlorophyllin chlorophyllin copper complex chlorophyllin copper complex chlorothymol chloroxlyneol chloroxlyneol chloroxlyneol
Monograph Sub-category Panel Pending digestive aid digestive aid cough/cold nasal decongestant III III digestive aid II/III III skin protectant diaper rash IIISE external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac skin protectant insect bites/stings w/ sales less than $25,000 skin protectant poison ivy/oak/sumac w/ sales less than $25,000 skin protectant w/ sales less than $25,000 oral health care IIISE digestive aid antidiarrheal w/ sales less than $25,000 III III acute toxic ingestion I antacid IIIE deodorants for internal use III III overindulgence in a hangover minimizer IIIE poison treatment I digestive aid III III cough/cold antitussive I external analgesic analgesic & anesthetic II II external analgesic counter irritant I I external analgesic fever blister/cold sore II II external analgesic poison ivy/oak/sumac II II skin protectant poison ivy/oak/sumac cough/cold antihistamine I acne II II corn/callus remover II IISE external analgesic analgesic & anesthetic III III external analgesic fever blister/cold sore III III external analgesic poison ivy/oak/sumac III III cough/cold expectorant II digestive aid pediculicide relief of oral discomfort IIISE deodorants for internal use III I oral health care IIIE antifungal III III antimicrobial IIIE antimicrobial IIIE antimicrobial IIISE
April 7, 2010
Final 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(6)(ii)(B) 310.545(a)(8)(i)
FR Citation
310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(8)(ii) 310.545(a)(3)(ii)
[55 FR 19864] [48 FR 32873] 310.545(a)(8)(iii) 341.14(a)(1) 310.545(a)(10)(i) 310.545(a)(10)(ii) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 341.12(b) 310.545(a)(1)
oral
[55 FR 33261] 310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(6)(iii) 310.545(a)(8)(ii) 310.545(a)(25)(i) 357.810(b) 310.545(a)(22)(ii)
OTC Active Ingredients
UNII Code LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT LJ25TI0CVT V1Q0O9OJ9Z V1Q0O9OJ9Z V1Q0O9OJ9Z O1GX33ON8R 1C6V77QF41 1C6V77QF41 1C6V77QF41 N91BDP6H0X N91BDP6H0X N91BDP6H0X XR12Z4HLEA K73E24S6X9 T4B6SPQ0UF E5GY4I6YCZ 5S29HWU6QB 5437O7N5BH 2968PHW8QP 2968PHW8QP 47EQO8LE7H 7BHQ856EJ5 7BHQ856EJ5 I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G I5ZZY3DC5G G07GZ97H65
Active Ingredient Monograph Sub-category chloroxlyneol antimicrobial chloroxlyneol antimicrobial chloroxlyneol antimicrobial chloroxlyneol antimicrobial chloroxlyneol antimicrobial chloroxlyneol antimicrobial chloroxylenol acne chloroxylenol antifungal chloroxylenol dandruff chlorpheniramine maleate cough/cold antihistamine chlorpheniramine maleate external analgesic poison ivy/oak/sumac chlorpheniramine maleate skin protectant poison ivy/oak/sumac chlorprophenpyridamine maleate menstrual/diuretic first aid antibiotic ointment chlortetracycline hydrochloride cholecalciferol skin protectant diaper rash cholecalciferol weight control cholecalciferol (vitamin D) anorectal wound healing choline weight control choline salicylate internal analgesic choline salicylate menstrual/diuretic analgesic chondrus weight control cimicifuga racemosa menstrual/diuretic botanical/vegetable herb cinnamedrine hydrochloride menstrual/diuretic muscle relaxant cinnamon oil digestive aid cinnamon tincture digestive aid cinoxate sunscreen citrate (containing active ingredients: citrate ion, as citric acid or salt) antacid citric acid relief of oral discomfort citric acid weight control citrus pectin digestive aid clioquinol antifungal clioquinol (lodochlorhydroxyquin) antifungal cloflucarban antimicrobial cloflucarban antimicrobial cloflucarban antimicrobial cloflucarban antimicrobial cloflucarban antimicrobial cloflucarban antimicrobial cloflucarban antimicrobial cloflucarban antimicrobial clotrimazole antifungal
April 7, 2010
Panel
II III III I
III(e,i) I I II III
I
I I
Pending IIISE IIISE IIISE IIISE IIISE IIISE II III III I
I IIISE II III(e,i) II I III II IIIE
I I IIIE II I I IIIS IIISE IIISE IISE IISE IISE IISE IISE I
Final
310.545(a)(1) 310.545(a)(22)(iv) 310.545(a)(7) 341.12(c) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(24)(i) 333.110(c) 310.545(a)(20) 310.545(a)(26)(x) 310.545(a)(20)
310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 352.10(c) 331.11(e) 310.545(a)(20) 310.545(a)(8)(ii) 333.210(a) 333.210(a)
333.210(g)
FR Citation
OTC Active Ingredients
UNII Code G07GZ97H65 578389D6D0 BPF36H1G6S 6L5ZL09795 6L5ZL09795 R533ES02EC R533ESO2EC R533ESO2EC R533ESO2EC R533ESO2EC 5120YT1CRR 512OYT1CRR 512OYT1CRR 512OYT1CRR 512OYT1CRR BBL281NWFG BBL281NWFG BBL281NWFG BBL281NWFG Q830PW7520 Q830PW7520 Q830PW7520 GSL05Y1MN6 GSL05Y1MN6 11QV9BS0CB 11QV9BS0CB J9BTD5377V IOS9HV04K7 8PI54V663Y 8PI54V663Y 8PI54V663Y 8PI54V663Y 23H32AOH17 789U1901C5 789U1901C5 789U1901C5 789U1901C5 8470G57WFM 7D3VB244UX
Active Ingredient clotrimazole clove oil cloxyquin (chlorhydroxyquinoline) cnicus benedictus cnicus benedictus coal tar coal tar coal tar coal tar coal tar cocoa butter cocoa butter cocoa butter cocoa butter cocoa butter coconut oil soap, aqueous cod liver oil cod liver oil cod liver oil cod liver oil (in combination only) codeine codeine codeine codeine phosphate codeine phosphate codeine sulfate codeine sulfate collinsonia (extract stone root) collinsonia extract colloidal oatmeal colloidal oatmeal colloidal oatmeal colloidal oatmeal colocynth copper copper gluconate copper oleate copper undecylenate corn oil corn oil, aqueous emulsion corn silk
Monograph n/a skin protectant acne menstrual/diuretic weight control acne antifungal dandruff dandruff dandruff anorectal skin protectant skin protectant skin protectant skin protectant pediculicide anorectal cough/cold skin protectant anorectal cough/cold internal analgesic menstrual/diuretic cough/cold internal analgesic cough/cold internal analgesic menstrual/diuretic anorectal dandruff skin protectant skin protectant skin protectant laxative weight control weight control pediculicide antifungal weight control cholecystokinetic menstrual/diuretic
April 7, 2010
Sub-category astringent
Panel II II
psoriasis seborrheic dermatitis protectant diaper rash diaper rash fever blister/cold sore
wound healing antitussive diaper rash protectant antitussive
Pending I
II II ISIII ISIII ISIII I(e,i)
I II III(e,i) III
II II II II I I I I(e,i) III iii I I II III(e,i) IIIE I(e,i) I II
analgesic antitussive antitussive
I
I
II(e,i) II II
II(e,i) II
astringent diaper rash stimulant laxative
II I
II
FR Citation [67 FR 5942]
310.545(a)(18)(ii) 310.545(a)(1)
I(e,i) I II II I
other
Final
I
III I II II II II I II I II
310.545(a)(20) 310.545(a)(1) 310.545(a)(22)(ii) 358.710(c)(1) 358.710(b)(1) 358.710(a)(1) 346.14(a)(2) 310.545(a)(18)(iii) 310.545(a)(18)(iii) 347.10(d) 310.545(a)(25)(i) 310.545(a)(26)(x) [52 FR 30054] 346.14(b)(2) 341.14(a)(2)(i) 310.545(a)(23)(i) 310.545(a)(24)(i) 341.14(a)(2)(ii) 310.545(a)(23)(i) 341.14(a)(2)(iii) 310.545(a)(23)(i) 310.545(a)(24)(i) 310.545(a)(26)(vii) 310.545(a)(7) 310.545(a)(18)(ii) 347.10(f) 310.545(a)(12)(iv)(A) 310.545(a)(20) 310.545(a)(20) 310.545(a)(25)(i) 333.210(f) 310.545(a)(20) 357.210(a) 310.545(a)(24)(i)
oral
oral oral
OTC Active Ingredients
UNII Code O8232NY3SJ 9G5L16BK6N 8K1MK5E1FY
1MXY2UM8NV 1MXY2UM8NV 1MXY2UM8NV 1MXY2UM8NV 1MXY2UM8NV 1MXY2UM8NV LRX7AJ16DT LRX7AJ16DT LRX7AJ16DT P6YC3EG204 W0O1NHP4WE 7323N7T136 7323N7T136 7323N7T136 ZT934N0X4W 48TCX9A1VT Z4XE6IBF3V NH5000009I XYS8INN1I6 BPA9UT29BS B10YD955QW 1O6C93RI7Z 1O6C93RI7Z 1O6C93RI7Z 7SA290YK68 7355X3ROTS 9D2RTI9KYH IY9XDZ35W2
Active Ingredient corn silk, potassium extract corn starch corn syrup couch grass creosote creosote creosote, beechwood creosote, beechwood creosote, beechwood creosote, beechwood (oral) creosote, beechwood (topical) cresol cresol cresol cresol cresol cresol, saponated cupric sulfate cupric sulfate cupric sulfate cyanocobalamin (vitamin B12) cyclizine hydrochloride cyclomethycaine sulfate cyclomethycaine sulfate cyclomethycaine sulfate cysteine hydrochloride cystine danthron datura stramonium dehyrocholic acid dequalinium chloride dexbromopheniramine maleate dexchlorpheniramine maleate dexpanthenol dexpanthenol dexpanthenol dextran 70 dextromethorphan dextromethorphan hydrobromide dextrose diastase
Monograph Sub-category weight control skin protectant weight control menstrual/diuretic relief of oral discomfort skin protectant poison ivy/oak/sumac cough/cold antitussive external analgesic poison ivy/oak/sumac relief of oral discomfort cough/cold nasal decongestant cough/cold nasal decongestant oral health care anesthetic/analgesic oral health care non-antimicrobal relief of oral discomfort relief of oral discomfort skin protectant astringent dandruff external analgesic skin protectant astringent weight control weight control antiemetic external analgesic analgesic & anesthetic external analgesic fever blister/cold sore external analgesic poison ivy/oak/sumac skin protectant diaper rash weight control laxative stimulant laxative cough/cold anticholinergic digestive aid oral health care cough/cold antihistamine cough/cold antihistamine external analgesic poison ivy/oak/sumac external analgesic skin protectant diaper rash ophthalmic demulcents cough/cold antitussive cough/cold antitussive weight control digestive aid
April 7, 2010
Panel
Pending II I II
Final 310.545(a)(20) 347.10(q) 310.545(a)(20) 310.545(a)(24)(i)
FR Citation
IIIE 310.545(a)(18)(vi)(A) III
IIIE
[52 FR 30054] 310.545(a)(10)(vii)
III III II
IIISE III III IISE
310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(B) 310.545(a)(14)
IIISE IIISE II II
II
II
III III III
II
I I I
II II I III III III II I II II IIISE I I IIIE IIISE I I I II
310.545(a)(18)(ii) 310.545(a)(7) 310.545(a)(18)(ii) 310.545(a)(20) 310.545(a)(20) 336.10(a) 310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(18)(iii) 310.545(a)(20) 310.545(a)(12)(iv)(B) 310.53 310.545(a)(8)(i) 341.12(d) 341.12(e) 310.545(a)(10)(vii)
349.12(b) 341.14(a)(3) 341.14(a)(4) 310.545(a)(20) 310.545(a)(8)(ii)
oral oral
OTC Active Ingredients
UNII Code Z3D4AJ1R48 L6JW2TJG99 L6JW2TJG99 L6JW2TJG99 Z97702A5DG Z97702A5DG Z97702A5DG O7TSZ97GEP O7TSZ97GEP T1J0JOU64O 2UTZ0QC864 PGQ9BY2MDE D0250MG0W6 D0250MG0W6 84H8Z9550J 84H8Z9550J JB937PER5C 92RU3N3Y1O 92RU3N3Y1O 92RU3N3Y1O SMP2689462 F05Q2T2JA0 B762XZ551X 2456GO94TR 5YZ5R8I73Y 5YZ5R8I73Y 5YZ5R8I73Y 8GTS82S83M 8GTS82S83M 8GTS82S83M TC2D6JAD40 TC2D6JAD41 TC2D6JAD42 TC2D6JAD43 TC2D6JAD44 TC2D6JAD45
Active Ingredient diastase malt dibenzothiophene dibucaine dibucaine dibucaine dibucaine hydrochloride dibucaine hydrochloride dibucaine hydrochloride dicalcium phosphate dihydrate dicalcium phosphate dihydrate [see calcium phosphate, dibasic] dichlorodiphenyl trichloroethane (DDT) dichlorophen diethylhexyl butamido triazone digalloyl trioleate dihydroxyaluminum aminoacetate dihydroxyaluminum aminoacetic acid dihydroxyaluminum sodium carbonate dihydroxyaluminum sodium carbonate dimenhydrinate dimethicone dimethicone dimethicone dimethisoquin hydrochloride dioctyl sodium sulfosuccinate diolamine methoxycinnamate (diethanolamine methoxycinnamate) dioxybenzone diperodon diperodon hydrochloride diperodon hydrochloride diperodon hydrochloride diphenhydramine citrate diphenhydramine citrate diphenhydramine citrate diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine hydrochloride dipropylene glycol salicylate disodium hydrogen phosphate
Monograph Sub-category digestive aid acne anorectal local anesthetic external analgesic oral health care anesthetic/analgesic anorectal local anesthetic external analgesic oral health care anesthetic/analgesic anticaries gingivitis/plaque pediculicide antifungal sunscreen sunscreen antacid antacid antacid digestive aid antacid antiemetic skin protectant diaper rash skin protectant fever blister/cold sore skin protectant external analgesic pediculicide sunscreen sunscreen anorectal anesthetic corn/callus remover external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac cough/cold antihistamine cough/cold antitussive nighttime sleep aid antiemetic cough/cold antihistamine cough/cold antitussive external analgesic nighttime sleep aid antihistamine skin protectant poison ivy/oak/sumac sunscreen anticaries
April 7, 2010
Panel
Pending
II III(e,i) I II III(e,i) I II II
II I(e),III(i) I II I(e),III(i) I II NC IIIE II III
II III NA I
I I
I I II I I
I I I I I I I II I I
II
IISE
III
I III I III
IIIE I IIIE I IIISE
III II
IIISE NC
Final 310.545(a)(8)(ii) 310.545(a)(1) 346.10(c)
FR Citation
310.545(a)(14) 346.10(d) 310.545(a)(14) 310.545(a)(2)(ii)
310.545(a)(22)(ii) 310.545(a)(29) 331.11(a)(3) 331.11(a)(3) 331.11(a)(5) 310.545(a)(8)(i) 336.10(b)
347.10(g)
310.545(a)(29) 352.10(e) 310.545(a)(26)(vi) [55 FR 33261] 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 341.12(f) 341.14(a)(5) 338.10(b) 336.10(c) 341.12(g) 341.14(a)(6)
oral
oral
338.10(a) 310.545(a)(18)(vi)(A) 58 FR 28281 310.545(a)(2)(ii)
OTC Active Ingredients
UNII Code 6K7YS503HC CIK9F54ZHR F05Q2T2JA0 F05Q2T2JA0 F05Q2T2JA0 8K1MK5E1FY 8K1MK5E1FY R4CY19YS7C V9BI9B5YI2 V9BI9B5YI2 5X93W9OFZL ZEC193879Q ZEC193879Q ZEC193879Q M94R1PM439 7FLD91C86K E55SMD6DA8 91QY4PXU8Q 91QY4PXU8Q 9YQ9DI1W42 8I3XWY40L9 GN83C131XS GN83C131XS GN83C131XS GN83C131XS NLJ6390P1Z NLJ6390P1Z NLJ6390P1Z NLJ6390P1Z NLJ6390P1Z NLJ6390P1Z U6X61U5ZEG U6X61U5ZEG U6X61U5ZEG U6X61U5ZEG U6X61U5ZEG YKH834O4BH YKH834O4BH
Active Ingredient Monograph Sub-category docusate calcium sulfosuccinate laxative stool softener docusate potassium sulfosuccinate laxative stool softener docusate sodium pediculicide docusate sodium weight control docusate sodium sulfosuccinate laxative stool softener dodecaethylene glycol monolaurate (polyethylene glycol 600 monolauvaginal contraceptive dog grass digestive aid dog grass extract menstrual/diuretic domiphen bromide oral health care doxylamine succinate cough/cold antihistamine doxylamine succinate nighttime sleep aid antihistamine drometrizole trisiloxane sunscreen duodenal substance digestive aid anorectal local anesthetic dyclonine hydrochloride external analgesic dyclonine hydrochloride oral health care anesthetic/analgesic dyclonine hydrochloride ecamsule sunscreen edetate disodium relief of oral discomfort elaterin resin laxative stimulant laxative elecampane digestive aid elm bark cough/cold antitussive elm bark oral health care demulcents ensulizole (phenylbenzimidazole sulfonic acid) sunscreen enzacamene (4-methylbenzylidene camphor) sunscreen ephedrine cough/cold bronchodilator ephedrine (aqueous) cough/cold nasal decongestant ephedrine (jelly) cough/cold nasal decongestant ephedrine (oral) cough/cold nasal decongestant ephedrine hydrochloride cough/cold bronchodilator ephedrine hydrochloride external analgesic male genital desensitizer ephedrine hydrochloride ophthalmic vasoconstrictor ephedrine hydrochloride (aqueous) cough/cold nasal decongestant ephedrine hydrochloride (jelly) cough/cold nasal decongestant ephedrine hydrochloride (oral) cough/cold nasal decongestant ephedrine sulfate anorectal vasoconstrictor ephedrine sulfate cough/cold bronchodilator ephedrine sulfate (aqueous) cough/cold nasal decongestant ephedrine sulfate (jelly) cough/cold nasal decongestant ephedrine sulfate (oral) cough/cold nasal decongestant epinephrine anorectal vasoconstrictor epinephrine cough/cold bronchodilator
April 7, 2010
Panel
Pending
Final
II
310.545(a)(25)(i) 310.545(a)(20)
IIIE II
III NA II I I NA
II IIISE I IISE II I I I IISE II
III I I
IIIE I I
I
I I I III I
I III I I I III I I I III III(e,i) I
I I I III I I I I III I(e),III(i) I
FR Citation
310.545(a)(28)(i) 310.545(a)(8)(ii) 310.545(a)(24)(i) 341.12(h) [5 FR 6828] 310.545(a)(8)(i) 346.10(e)
310.545(a)(12)(iv)(A) 310.545(a)(8)(ii) [52 FR 30054] 352.10(n) 341.16(a) 341.20(b)(2) 341.20(b)(2) 310.545(a)(6)(ii)(B) 341.16(b) 310.545(a)(10)(iii) 349.18(a) 341.20(b)(3) 341.20(b)(3) 310.545(a)(6)(ii)(B) 346.12(a) 341.16(c) 341.20(b)(4) 341.20(b)(4) 310.545(a)(6)(ii)(B) 346.12(b) 341.16(d)
inhalation
OTC Active Ingredients
UNII Code YKH834O4BH 30Q7KI53AK 30Q7KI53AK WBB047OO38 WBB047OO38 VS041H42XC X3S33EX3KW X3S33EX3KW 514B9K0L10 2DI9HA706A 0F5N573A2Y M9JGK7U88V 54M9O25201 E1ZT886LR5 MFM5450P3T RV6J6604TK RV6J6604TK RV6J6604TK RV6J6604TK RV6J6604TK RV6J6604TK 2R04ONI662 2R04ONI663 2R04ONI664 2R04ONI665 2R04ONI666 2R04ONI667 2R04ONI668 2R04ONI669 2R04ONI670 2R04ONI671 2R04ONI672 2R04ONI673 3T8H1794QW 3T8H1794QW 3T8H1794QW 3T8H1794QW 3T8H1794QW L13YF113GN
Active Ingredient epinephrine epinephrine bitartrate epinephrine bitartrate epinephrine hydrochloride epinephrine hydrochloride epinephrine undecylenate ergocalciferol ergot fluid extract ergot fluidextract Escherichia coli vaccine estrone ether ethohexadiol ethyl 4-[bis(hydroxypropyl)] aminobenzoate (roxadimate) ethyl nitrate ethylmorphine hydrochloride eucalyptol eucalyptol eucalyptol eucalyptol eucalyptol (lozenge) eucalyptol (mouthwash) eucalyptol/eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil eucalyptus oil (lozenge) eucalyptus oil (mouthwash) eugenol eugenol eugenol eugenol eugenol euphorbia pilulifera fennel acid
Monograph Sub-category cough/cold bronchodilator cough/cold bronchodilator cough/cold bronchodilator anorectal vasoconstrictor cough/cold bronchodilator anorectal vasoconstrictor weight control skin protectant insect bites/stings external analgesic insect bite/sting anorectal other acne digestive aid dandruff sunscreen menstrual/diuretic cough/cold antitussive cough/cold antitussive cough/cold antitussive dandruff oral health care anesthetic/analgesic cough/cold nasal decongestant cough/cold nasal decongestant cough/cold expectorant cough/cold antitussive cough/cold antitussive cough/cold antitussive cough/cold nasal decongestant external analgesic counter irritant external analgesic fever blister/cold sore external analgesic poison ivy/oak/sumac skin protectant astringent skin protectant poison ivy/oak/sumac cough/cold nasal decongestant cough/cold nasal decongestant external analgesic analgesic & anesthetic external analgesic fever blister/cold sore external analgesic poison ivy/oak/sumac relief of oral discomfort skin protectant astringent cough/cold bronchodilator digestive aid
April 7, 2010
Panel Pending I I I I I I I(e),II(i) I(e),II(i) I I I I II
II
II
III I
III I
III
IIIE IIIE IIIE III III III III III IIIE IIIE IIIE IIIE I I I
III III III III III III III III I I I II III III III III III II III
III III III III III IIISE III
Final 341.16(d) 341.16(e) 341.16(e) 346.12(c) 310.545(a)(26)(ix) 310.545(a)(20) 310.545(a)(18)(v)(A) 310.545(a)(10)(vi) 310.545(a)(26)(vii) 310.545(a)(1) 310.545(a)(8)(ii) 310.545(a)(7) 310.545(a)(29) 310.545(a)(24)(i)
FR Citation rubber bulb inhalation rubber bulb
64 FR 27670 [52 FR 30054] [52 FR 30055] [52 FR 30055]
310.545(a)(7) 310.545(a)(14) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 310.545(a)(6)(iii) [52 FR 30055] [52 FR 30054] [52 FR 30055] [59 FR 43408] 310.545(a)(10)(ii) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(18)(ii) 310.545(a)(18)(vi)(A) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A) 310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(18)(ii) 310.545(a)(6)(iv) 310.545(a)(8)(ii)
OTC Active Ingredients
UNII Code UVP74NG1C5 U38V3ZVV3V U38V3ZVV3V U38V3ZVV3V U38V3ZVV3V QK8899250F 3QJ8WS6V8H R5L488RY0Q U1B11I423Z 39R4TAN1VT 39R4TAN1VT 4110YT348C 80OFG3WPYD 935E97BOY8 1HG84L3525 0YIW783RG1 S2D77IH61R 6YSS42VSEV 6YSS42VSEV BIA2SO6F5B 7556HJ7587 V1V998DC17 2G86QN327L 2G86QN327L J4Z741D6O5 J4Z741D6O5 S72O3284MS C5529G5JPQ ZQH6VH092Z ZQH6VH092Z 3KX376GY7L PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX
Active Ingredient ferric acid ferric ammonium citrate ferric chloride ferric chloride ferric chloride ferric chloride ferric pyrophosphate ferric subsulfate (Monsel's solution) ferrous fumarate ferrous gluconate ferrous sulfate ferrous sulfate (iron) flax seed fluorosalan folic acid formaldehyde solution formic acid frangula fructose fructose galega gamboge garlic, dehydrated gelatin gelatin gentian violet gentian voilet gentiana lutea (gentian) ginger ginseng ginseng glutamic acid hydrochloride glycerin glycerin glycerin glycerin glycerin glycerin glycerin glycerin glycerin
Monograph Sub-category skin protectant poison ivy/oak/sumac weight control external analgesic insect bite/sting menstrual/diuretic oral health care skin protectant insect bites/stings weight control skin protectant astringent weight control weight control menstrual/diuretic weight control weight control antimicrobial weight control relief of oral discomfort pediculicide laxative stimulant laxative overindulgence in a inebriation minimizer weight control digestive aid laxative stimulant laxative digestive aid ophthalmic demulcents oral health care demulcents oral health care anthelmintic menstrual/diuretic digestive aid nighttime sleep aid stimulant digestive aid stomach acidifier anorectal protectant external analgesic poison ivy/oak/sumac laxative hyperosmotic ophthalmic demulcents oral health care otic skin protectant diaper rash skin protectant fever blister/cold sore skin protectant insect bites/stings
April 7, 2010
Panel
Pending II
Final 310.545(a)(18)(vi)(A) 310.545(a)(20) 310.545(a)(10)(vi) 310.545(a)(24)(i)
FR Citation
IISE II II II II II II IIS II IIIE III IIIE II
II I I I
II II I I IIE II
310.545(a)(18)(v)(A) 310.545(a)(20) 310.545(a)(18)(ii) 310.545(a)(20) 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(25)(i) 310.545(a)(12)(iv)(A) [48 FR 32873] 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(12)(iv)(A) 310.545(a)(8)(i) 349.12(c)
310.545(a)(24)(i) 310.545(a)(8)(ii)
II I(e)
I
I
II IIE II I(e) I I I IIIE IIISE I IISE
[39 FR 6104] 310.545(a)(8)(i) 346.14(a)(3) 310.545(a)(10)(vii) 349.12(d)(1) [51 FR 28660] 310.545(a)(18)(iii) 310.545(a)(18)(vi)
OTC Active Ingredients
UNII Code PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX PDC6A3C0OX A886B5N5IM 230OU9XXE4 230OU9XXE4 230OU9XXE4 TE7660XO1C TE7660XO1C TE7660XO1C
61ZBX54883 5IE62321P4 495W7451VQ E89I1637KE E89I1637KE AIU7053OWL 8334LX7S21 8334LX7S21
IWW5FV6NK2 R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N R9QTB5E82N 3POA0Q644U 4QD397987E 68JRS2HC1C
Active Ingredient glycerin glycerine and anhydrous glycerine glycerine and anhydrous glycerine glycerine and anhydrous glycerine glyceryl aminobenzoate (lisadimate, glyceryl PABA) glyceryl stearate glyceryl stearate glyceryl stearate glycine glycine glycine (aminoacetic acid) glycol salicylate glycol salicylate glycyrrhiza (licorice) gramicidin guaifenesin guar gum guar gum haloprogin hard fat hard fat hectorite hectorite hectorite hemicellulase hexachlorophene hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol hexylresorcinol histamine dihydrochloride histidine homatropine methylbromide
Monograph skin protectant otic skin protectant skin protectant sunscreen skin protectant skin protectant skin protectant antidiarrheal digestive aid antacid external analgesic external analgesic menstrual/diuretic first aid antibiotic cough/cold laxative weight control antifungal anorectal skin protectant digestive aid external analgesic skin protectant digestive aid antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial external analgesic external analgesic external analgesic oral health care external analgesic weight control antidiarrheal
April 7, 2010
Sub-category
Panel I
Pending I
diaper rash poison ivy/oak/sumac
III
I insect bites/stings w/ sales less than $25,000 poison ivy/oak/sumac w/ sales less than $25,000 w/ sales less than $25,000 II
I
II
fever blister/cold sore poison ivy/oak/sumac
III III
I III III
I
III IIIE III III I
III
III
III III III I
I I IIE IIIE IIIE IIIE IIIE IIIE III III III I
III
II III
expectorant bulk laxative
protectant
poison ivy/oak/sumac poison ivy/oak/sumac
Final 347.10(h) 310.545(a)(15)(ii) 310.545(a)(18)(iii) 310.545(a)(18)(vi)(A) 310.545(a)(29) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(3)(i) 310.545(a)(8)(ii) 331.11(f) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(24)(i)
FR Citation
64 FR 27670
341.18 310.545(a)(12)(i) 310.545(a)(20) 333.210(b) 346.14(a)(4) 347.10(i) 310.545(a)(8)(ii) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(8)(i) [37 FR 20163]
analgesic & anesthetic fever blister/cold sore poison ivy/oak/sumac anesthetic/analgesic fever blister/cold sore
310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(10)(v) 310.545(a)(20) 310.545(a)(3)(i)
OTC Active Ingredients
UNII Code 68JRS2HC1C 68JRS2HC1C V06SV4M95S Y9H1V576FH 7A72MUN24Z 7A72MUN24Z 7A72MUN24Z SC52PT1846 9P2U39H18W 658O6T0WXZ 658O6T0WXZ S1EFO94F35 ZW3Z11D0JV ZW3Z11D0JV 1E8C2W13Z0 QTT17582CB NO70W886KK WI4X0X7BPJ WI4X0X7BPJ WI4X0X7BPJ WI4X0X7BPJ 3X7931PO74 3X7931PO75 3X7931PO76 3X7931PO77 RGL5YE86CZ BBX060AN9V BBX060AN9V BBX060AN9V BBX060AN9V BBX060AN9V BBX060AN9V BBX060AN9V BBX060AN9V BBX060AN9V XV74C1N1AE 273FM27VK1 F2R8V82B84
Active Ingredient Monograph homatropine methylbromide digestive aid homatropine methylbromide menstrual/diuretic homosalate sunscreen skin protectant honey horehound cough/cold horehound cough/cold horehound oral health care horsetail digestive aid digestive aid huckleberry hydrastis anorectal hydrastis anorectal hydrastis canadensis weight control hydrastis canadensis (golden seal) digestive aid hydrastis canadensis (golden seal) menstrual/diuretic hydrastis fluid extract digestive aid hydrate magnesium aluminate activated sulfate antacid hydrochloric acid digestive aid hydrocodone bitartrate cough/cold hydrocortisone external analgesic hydrocortisone (0.25-5%) external analgesic hydrocortisone (0.5-1%) external analgesic hydrocortisone (combination) anorectal hydrocortisone acetate external analgesic hydrocortisone acetate external analgesic hydrocortisone acetate (0.25-5.0%) external analgesic hydrocortisone acetate (0.25%-0.5%) external analgesic hydrocortisone preparations dandruff hydrogen fluoride anticaries hydrogen peroxide antimicrobial hydrogen peroxide external analgesic hydrogen peroxide oral health care hydrogen peroxide oral health care hydrogen peroxide oral health care hydrogen peroxide skin protectant hydrogen peroxide and povidone iodine gingivitis/plaque hydrogen peroxide and sodium bicarbonate gingivitis/plaque hydrogen peroxide, sodium citrate, sodium lauryl sulfate, and zinc ch gingivitis/plaque hydroquinone skin bleach ophthalmic hydroxyethylcellulose ophthalmic hydroxypropyl methycellulose antidiarrheal hyocyamine sulfate
April 7, 2010
Sub-category muscle relaxant astringent antitussive expectorant expectorant
antiseptic counterirritant
antitussive
Panel II/III II I II III
Pending III II I
Final 310.545(a)(8)(i) 310.545(a)(24)(i) 352.10(f) 310.545(a)(18)(ii)
IIIE
[52 FR 30054] 310.545(a)(6)(iii)
III
II(e,i) II(e,i)
II(e,i) II(e,i) II
II
II
II I I
IIS I I IIISE
I I I I III NC
I I I I IS III I
I
I III IIIE
310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(26)(ii) 310.545(a)(26)(iv) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(24)(i) 310.545(a)(8)(ii) 331.11(g)(1) 310.545(a)(8)(ii) [52 FR 30054]
310.545(a)(26)(xi)
poison ivy/oak/sumac wound cleansing
310.545(a)(2)(i) 310.545(a)(10)(vii)
poison ivy/oak/sumac
demulcents demulcents
FR Citation
310.545(a)(18)(vi)(A)
I I III
IIISE IIISE IIISE I I I III
349.12(a)(2) 310.545(a)(3)(i)
OTC Active Ingredients
UNII Code F2R8V82B84 3NXW29V3WO WK2XYI10QM WK2XYI10QM SY15A62UPX SY15A62UPX 969IQC5YJU 4L6452S749 9679TC07X4 9679TC07X5 9679TC07X6 9679TC07X7 9679TC07X8
9679TC07X10 9679TC07X11 9679TC07X4 9679TC07X5 9679TC07X6 9679TC07X7 9679TC07X8 9679TC07X9 9679TC07X4 V30V6H1QX4 62I3C8233L 62I3C8233L 62I3C8233L 62I3C8233L 62I3C8233L 62I3C8233L 62I3C8233L
Active Ingredient Monograph Sub-category hyoscyamine sulfate menstrual/diuretic hypromellose ophthalmic demulcents ibuprofen internal analgesic ibuprofen internal analgesic ichthammol corn/callus remover impatiens biflora tincture external analgesic poison ivy/oak/sumac impatiens biflora tincture skin protectant poison ivy/oak/sumac infusion of rose petals ophthalmic astringent inositol weight control expectorant iodides (calcium iodide anyhydrous, hydroidic acid syrup, iodized lim cough/cold iodine corn/callus remover iodine digestive aid iodine oral health care iodine wart remover iodine weight control antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene antimicrobial iodine complex/phosphate ester of alkylaryloxy polyethylene iodine tincture antimicrobial iodine tincture antimicrobial iodine tincture antimicrobial iodine tincture antimicrobial iodine tincture antimicrobial iodine tincture antimicrobial iodine tincture antimicrobial iodine tincture antimicrobial iodine topical solution antimicrobial internal analgesic iodoantipyrine (idopyrine) ipecac cough/cold expectorant ipecac fluidextract cough/cold expectorant ipecac fluidextract poison treatment ipecac syrup cough/cold expectorant ipecac syrup emetic ipecac syrup poison treatment ipecac tincture poison treatment ipomea laxative stimulant laxative iron ox bile digestive aid
April 7, 2010
Panel
Pending
II
I I I IISE
III
II
III II II IISE
Final 310.545(a)(24)(i) 349.12(a)(3)
FR Citation
[67 FR 54139] [67 FR 54139] [55 FR 33261] 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(21)(iii) 310.545(a)(20) 310.545(a)(6)(iii) [55 FR 33261] 310.545(a)(8)(ii)
II
II
IIISE IISE II IIISE IIISE IIISE IIISE IIISE IIISE IISE IISE IISE I I IIIS IIIS IIISE IIS I II II II III I I II II
[55 FR 33254] 310.545(a)(20)
310.545(a)(23)(i) 310.545(a)(6)(iii) 310.545(a)(6)(iii) 310.545(a)(16) 310.545(a)(6)(iii) 337.10 310.545(a)(16) 310.545(a)(12)(iv)(A) 310.545(a)(8)(ii)
OTC Active Ingredients
UNII Code 1K09F3G675 1K09F3G675 04Y7590D77 ND2M416302 ND2M416303 ND2M416304 ND2M416305 ND2M416306 ND2M416307 ND2M416308 8CRQ2TH63M 8CRQ2TH63M 8CRQ2TH63M 4UDO46YBK2 XK4IUX8MNB YNW2QPG8YK
24H4NWX5C0 24H4NWX5C0 24H4NWX5CO 24H4NWX5CO 24H4NWX5CO
64Y2IV7284 33X04XA5AT 33X04XA5AT
J2B2A4N98G J2B2A4N98G 7EV65EAW6H 7EV65EAW6H 7EV65EAW6H 7EV65EAW6H
Active Ingredient iron oxide iron oxide isobornyl thiocycanoacetate isoleucine isopropyl alcohol isopropyl alcohol isopropyl alcohol isopropyl alcohol isopropyl alcohol isopropyl alcohol isopropyl alcohol isopropyl palmitate isopropyl palmitate isopropyl palmitate jalap johnswort juniper oil (oil of juniper) juniper tar juniper tar juniper tar juniper tar juniper, potassium extract kaolin kaolin kaolin kaolin kaolin, colloidal karaya gum karaya gum kelp knotgrass lactic acid lactic acid Lactobacillus acidophilis Lactobacillus bulgaricus lactose lactose lanolin lanolin lanolin lanolin
Monograph external analgesic skin protectant pediculicide weight control alcohols (topical) external analgesic mercury otic otic skin protectant skin protectant skin protectant skin protectant skin protectant laxative digestive aid menstrual/diuretic anorectal dandruff digestive aid external analgesic weight control anorectal antidiarrheal skin protectant skin protectant digestive aid laxative weight control weight control digestive aid digestive aid wart remover antidiarrheal antidiarrheal digestive aid weight control anorectal external analgesic skin protectant skin protectant
Sub-category poison ivy/oak/sumac poison ivy/oak/sumac
April 7, 2010
Panel
Pending
II
II II I
I poison ivy/oak/sumac
Final 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(25)(i) 310.545(a)(20)
FR Citation
310.545(a)(10)(vii) I
astringent II poison ivy/oak/sumac insect bites/stings w/ sales less than $25,000 poison ivy/oak/sumac w/ sales less than $25,000 w/ sales less than $25,000 stimulant laxative
analgesic, anesthetic, antipruritic
protectant
II
II III(e,i) III
II I(e) III
I
I II I(e,i) IIIE I I
I(e,i) III
diaper rash I
I III III
protectant poison ivy/oak/sumac diaper rash poison ivy/oak/sumac
III III III
IIIE III III
I(e,i)
II I(e,i)
344.12 310.545(a)(15)(ii) 310.545(a)(18)(ii) 310.545(a)(18)(vi)(A) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(12)(iv)(A) 310.545(a)(8)(ii) 310.545(a)(24)(i) 346.16(b) 310.545(a)(7) 310.545(a)(8)(ii) 310.545(a)(20) 346.14(a)(5) 335.10(b) 347.10(j) 310.545(a)(8)(ii) 310.545(a)(20) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(8)(ii) [55 FR 33254] 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(8)(ii) 310.545(a)(20) 346.14(a)(6) 310.545(a)(10)(vii)
I 310.545(a)(18)(vi)(A)
OTC Active Ingredients
UNII Code 7EV65EAW6H 7EV65EAW6H
09TM5K0O34 9YT4B71U8P TLH4A6LV1W RX077P88RY RX077P88RY
GMW67QNF9C Y24T9BT2Q2 Y24T9BT2Q2 98PI200987 98PI200988 98PI200989 98PI200990 98PI200991 V13007Z41A V13007Z41A CFN6G1F6YK 3NY3SM6B8U 3NY3SM6B8U 3NY3SM6B8U 3NY3SM6B8U 3NY3SM6B8U K3Z4F929H6 JNJ23Q2COM JNJ23Q2COM I38ZP9992A 6M2P64V0NC 6M2P64V0NC
Active Ingredient lanolin lanolin lanolin (in combination) lanolin alcohols lanolin nonionic derivatives lanolin, anhydrous (in combination) lappa extract laureth 10S lauryl isoquinolinium bromide lavender compound, tincture of lawsone (w/ dihydroxyacetone) lead acetate lead acetate lecithin leptandra extract leucine levmetamfetamine levmetamfetamine lidocaine lidocaine lidocaine lidocaine lidocaine lidocaine hydrochloride lidocaine hydrochloride linden lipase live yeast cell derivative live yeast cell derivative live yeast cell derivative live yeast cell derivative live yeast cell derivative liver concentrate lysine lysine aspirin lysine hydrochloride lysine hydrochloride magaldrate magnesium magnesium aluminosilicate magnesium aluminosilicate
Monograph Sub-category skin protectant poison ivy/oak/sumac skin protectant ophthalmic emollient anorectal protectant ophthalmic ophthalmic emollient anorectal other vaginal contraceptive dandruff digestive aid sunscreen external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac weight control anorectal other weight control cough/cold nasal decongestant cough/cold nasal decongestant anorectal local anesthetic external analgesic male genital desensitizer external analgesic oral health care anesthetic/analgesic skin protectant poison ivy/oak/sumac external analgesic oral health care anesthetic/analgesic digestive aid digestive aid anorectal other anorectal wound healing skin protectant insect bites/stings w/ sales less than $2 poison ivy/oak/sumac w/ sales less than skin protectant skin protectant w/ sales less than $25,000 weight control weight control internal analgesic digestive aid weight control antacid weight control antacid antacid
April 7, 2010
Panel
Pending IISE
I I(e,i) I I II(e,i) III
I III(e,i) I I II(e,i) IIIE III
I
I
I II
II II(e,i) II I I I(e),III(i) I I II
I II
I II
III(e,i) III III III
III(e,i) III III III II II
II(e,i)
III(e,i)
II I II I I
Final 310.545(a)(18)(vi) 347.10(k) 349.14(a)(2) 310.545(a)(26)(viii) 349.14 349.14(a)(1) 310.545(a)(26)(vii) 310.545(a)(28)(i) 310.545(a)(7) 310.545(a)(8)(ii) 310.545(a)(29) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(20) 310.545(a)(26)(vii) 310.545(a)(20) 341.20(b)(1) 341.20(b)(1) 346.10(f) 348.10(a)(2) 310.545(a)(14) 310.545(a)(18)(vi)(A) 310.545(a)(14) 310.545(a)(8)(ii) 310.545(a)(8)(ii) 310.545(a)(26)(vii) 310.545(a)(26)(x) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(20) 310.545(a)(20) 310.545(a)(23)(i) 310.545(a)(8)(ii) 310.545(a)(20) 331.11(g)(2) 310.545(a)(20) 331.11(g)(3) 331.11(l)(1)
FR Citation
inhalant topical
OTC Active Ingredients
UNII Code 6M2P64V0NC 0E53J927NA 0E53J927NA RHO26O1T9V IFN18A4Y6B NBZ3QY004S NBZ3QY004S NBZ3QY004S 3A3U0GI71G 3A3U0GI71G 41728CY7UX 41728CY7UX DE08037SAB DE08037SAB DE08037SAB C2E1CI501T C2E1CI501T C2E1CI501T C2E1CI501T R3NBG8914U 7CVR7L4A2D 4Z2OA6A13N 3OWL53L36A 3OWL53L36A GGO4Y809LO HDP7W44CIO L7T10EIP3A L7T10EIP3A L7T10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A
Active Ingredient magnesium aluminum silicate magnesium carbonate magnesium carbonate magnesium citrate (oral) magnesium glycinate magnesium hydroxide magnesium hydroxide magnesium hydroxide magnesium oxide magnesium oxide magnesium salicylate magnesium salicylate magnesium sulfate magnesium sulfate magnesium sulfate magnesium trisilicate magnesium trisilicate magnesium trisilicate magnesium trisilicate malt malt soup extract maltodextrin manganese citrate mannitol mannitol m-cresol meclizine hydrochloride menfegol menthol menthol menthol menthol menthol menthol menthol menthol menthol menthol menthol menthol menthol
Monograph Sub-category acne antacid overindulgence in a hangover reliever laxative saline laxative antacid antacid digestive aid antacid laxative saline laxative antacid weight control internal analgesic menstrual/diuretic analgesic acne laxative saline laxative menstrual/diuretic antacid antacid digestive aid antacid overindulgence in a hangover reliever weight control laxative weight control weight control digestive aid weight control antifungal antiemetic vaginal contraceptive antifungal dandruff skin protectant astringent anorectal analgesic, anesthetic, antipruritic anorectal counterirritant cough/cold antitussive cough/cold antitussive cough/cold antitussive cough/cold antitussive cough/cold nasal decongestant external analgesic oral health care anesthetic/analgesic relief of oral discomfort
April 7, 2010
Panel
III
I I II
III
Pending I I I I I I I I II I II I I I I I II I II II II
II III II II(e,i) III III III III I I
I I II III I(e) II(e,i) IIIE IIIE I I IIIE I I IIS
Final 310.545(a)(1) 331.11(g)(4)
FR Citation
331.11(g)(5) 331.11(g)(6) 310.545(a)(8)(i) 331.11(g)(7) 310.545(a)(20)
310.545(a)(1) 310.545(a)(24)(i) 331.11(g)(8) 331.11(l)(2) 310.545(a)(8)(i) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(20) 310.545(a)(22)(iv) 336.10(d) 310.545(a)(22)(ii) 310.545(a)(7) 310.545(a)(18)(ii) 346.16(c) 310.545(a)(26)(iv) 341.14(b)(2) 341.14(b)(2) 341.14(b)(2) 341.14(b)(2)
steam inhalation lozenge lozenge topical [59 FR 43408]
OTC Active Ingredients
UNII Code LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A LT10EIP3A L7T10EIP3A J9QGD60OUZ M0T18YH28D M0T18YH28D M0T18YH28D 53GH7MZT1R 53GH7MZT1R 53GH7MZT1R IY191986AO
FXS1BY2PGL
GJ20H50YF0 KJ5I25TXYL KJ5I25TXYL KJ5I25TXYL 00S42N58OM 00S42N58OM 00S42N58OM 00S42N58OM 00S42N58OM 00S42N58OM J50OIX95QV AE28F7PNPL 52V8BVV7FX 7B1AVU9DJN
Active Ingredient Monograph Sub-category menthol skin protectant insect bites/stings menthol skin protectant poison ivy/oak/sumac menthol wart remover menthol (0.1 to 1.0%) external analgesic menthol (mouthwash) cough/cold antihistamine menthol exceeding 1% external analgesic fever blister/cold sore menthol/peppermint oil cough/cold expectorant meradimate (menthyl anthranilate) sunscreen meralein sodium oral health care merbromin external analgesic poison ivy/oak/sumac merbromin skin protectant poison ivy/oak/sumac merbromin (mercurochrome) antimicrobial first aid antiseptic mercufenol chloride (orthochloromercuriphenol, orthohydroxyphenyl antimicrobial first aid antiseptic mercuric chloride external analgesic poison ivy/oak/sumac mercuric chloride skin protectant poison ivy/oak/sumac mercuric chloride (bichloride of mercury, mercury chloride) antimicrobial first aid antiseptic mercuric oxide, yellow antimicrobial first aid antiseptic mercuric salicylate antimicrobial first aid antiseptic mercuric sulfide, red antimicrobial first aid antiseptic antimicrobial first aid antiseptic mercury mercury oleate antimicrobial first aid antiseptic mercury oleate dandruff mercury sulfide antimicrobial first aid antiseptic mercury, ammoniated skin bleach mercury-containing ingredient antimicrobial diaper rash mercury-containing ingredients vaginal contraceptive metaproterenol sulfate cough/cold antihistamine methapyrilene fumarate cough/cold antihistamine methapyrilene fumarate internal analgesic methapyrilene fumarate nighttime sleep aid antihistamine cough/cold antihistamine methapyrilene hydrochloride external analgesic analgesic & anesthetic methapyrilene hydrochloride external analgesic fever blister/cold sore methapyrilene hydrochloride external analgesic poison ivy/oak/sumac methapyrilene hydrochloride menstrual/diuretic methapyrilene hydrochloride nighttime sleep aid antihistamine methapyrilene hydrochloride methenamine menstrual/diuretic methionine weight control methoxyphenamine hydrochloride cough/cold bronchodilator vaginal contraceptive methoxypolyoxyethyleneglycol 550 laurate methyl nicotinate external analgesic fever blister/cold sore
April 7, 2010
Panel
Pending
II I III
IISE I III
I
III I IISE
II
II
I I III II I I I I
I II II IIS II II II II
II
IIS
I
II II IIIE
Final 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A)
FR Citation
[55 FR 33254] 310.545(a)(6)(ii)(A) 310.545(a)(10)(v) 310.545(a)(6)(iii) 352.10(h) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(27)(i) 310.545(a)(7) 310.545(a)(27)(i) 310.545(a)(17) 310.545(a)(27)(ii) 310.545(a)(28)(i) 310.545(a)(6)(iv) 310.545(a)(6)(i) 310.545(a)(23)(i) [54 FR 6826] 310.545(a)(6)(i) 310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(24)(i) [54 FR 6826] 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(6)(iv) 310.545(a)(28)(i) 310.545(a)(10)(v)
OTC Active Ingredients
UNII Code LAV5U5022Y LAV5U5022Y LAV5U5022Y LAV5U5022Y LAV5U5022Y LAV5U5022Y LAV5U5022Y
4GFU244C4J 4GFU244C4J 4GFU244C4J T42P99266K A2I8C7HI9T VW4H1CYW1K 917J3173FT N6K5787QVP T5L8T28FGP T5L8T28FGP T5L8T28FGP T5L8T28FGP T5L8T28FGP 9936O846LI N4G8379626 JC71GJ1F3L JC71GJ1F3L JC71GJ1F3L MZ1131787D MZ1131787D MZ1131787D
Active Ingredient methyl salicylate methyl salicylate methyl salicylate methyl salicylate methyl salicylate methyl salicylate methyl salicylate methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylbenzethonium chloride methylcellulose methylcellulose methylcellulose methylene blue methylparaben miconazole nitrate mild silver protein milk solids, dried minaeral oil mineral oil mineral oil mineral oil mineral oil mineral oil, light mono- and di-glycerides mullein mustard oil (alltlishthiocyanate) (tpoical/inhalant) mycozyme myrrh myrrh tincture myrrh, fluid extract of naphazoline hydrochloride naphazoline hydrochloride naphazoline hydrochloride
Monograph Sub-category corn/callus remover dandruff external analgesic fever blister/cold sore oral health care anesthetic/analgesic relief of oral discomfort relief of oral discomfort skin protectant astringent antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial corn/callus remover dandruff laxative ophthalmic demulcents weight control menstrual/diuretic antifungal antifungal ophthalmic anti-infective antacid skin protectant diaper rash anorectal protectant laxative lubricant ophthalmic emollient skin protectant ophthalmic emollient weight control anorectal other cough/cold nasal decongestant digestive aid relief of oral discomfort oral health care astringent digestive aid cough/cold nasal decongestant cough/cold nasal decongestant ophthalmic vasoconstrictor
April 7, 2010
Panel II III
Pending IISE III
III
III IISE IISE
Final
FR Citation [55 FR 33261]
310.545(a)(7) 310.545(a)(10)(v) 310.545(a)(14)
310.545(a)(18)(ii)
II III I
III I III
I I IIIE IIISE IIISE IIISE IIISE IISE IISE III I I III
II(e,i) II
III I II I I I(e,i) I I I I II II(e,i) II
II
IIISE II
I
I I I
I(e,i) I I
[55 FR 33261] 310.545(a)(7) 349.12(a)(4) 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(22)(ii) 333.210(c) 310.545(a)(21)(ii) 331.11(h) 346.14(a)(7) 349.14(b)(2) 347.10(l) 349.14(b)(1) 310.545(a)(20) 310.545(a)(26)(vii) 310.545(a)(8)(ii) 310.545(a)(14) 310.545(a)(8)(ii) 341.20(b)(6) 341.20(b)(6) 349.18(b)
OTC Active Ingredients
UNII Code MZ1131787D MZ1131787D
Active Ingredient naphazoline hydrochloride (jelly) naphazoline hydrochloride (jelly) natural estrogenic horomone I16QD7X297 neomycin ointment (combination only) 057Y626693 neomycin sulfate 057Y626693 neomycin sulfate cream 0GG6WIU2KW nettle 25X51I8RD4 niacinamide 25X51I8RD4 niacinamide 25X51I8RD4 niacinamide nickel-pectin nitromersol RU6242GP15 nitromersol RU6242GP15 nonylphenoxypoly nonoxynol 9 nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine nonylphenoxypoly (ethyleneoxy) ethanol iodine noscapine noscapine hydrochloride AEE24M3MQ9 nutmeg oil (oil of nutmeg) nux vomica extract 269XH13919 BDF1O1C72E nystatin obtundia surgical dressing obtundia surgical dressing octinoxate (octyl methoxycinnamate; ethylhexyl methoxycinnamate) 4Y5P7MUD51 octisalate (octyl salicylate; ethylhexyl salicylate) 4X49Y0596W octocrylene 5A68WGF6WM octoxynol 9 7JPC6Y25QS octyl triazone (ethylhexyl triazone) oil of erigeron Opium powder Opium tincture organic vegetables orthophosphoric acid E4GA8884NN ox bile ox bile extract 95OOS7VE0Y oxybenzone (benzophenone-3) K89MJ0S5VY oxymetazoline hydrochloride (aqueous)
Monograph Sub-category cough/cold nasal decongestant cough/cold nasal decongestant menstrual/diuretic first aid antibiotic first aid antibiotic ointment first aid antibiotic digestive aid menstrual/diuretic nighttime sleep aid weight control digestive aid antimicrobial first aid antiseptic oral health care vaginal contraceptive antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial cough/cold antitussive cough/cold antitussive menstrual/diuretic digestive aid antifungal external analgesic skin protectant insect bites/stings sunscreen sunscreen sunscreen vaginal contraceptive sunscreen menstrual/diuretic antidiarrheal antidiarrheal weight control digestive aid laxative stimulant laxative digestive aid sunscreen cough/cold nasal decongestant
April 7, 2010
Panel I I
Pending I I I I I
II II
III III
I
I I I
Final 341.20(b)(6) 341.20(b)(6) 310.545(a)(24)(i) 333.120 333.110(d) 333.110(e) 310.545(a)(8)(ii) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(27)(i)
IISE I IIISE IIISE IIISE IIISE IIISE IISE IIIE IIIE
III IISE IISE I I I I
[52 FR 30054] [52 FR 30054] 310.545(a)(24)(i) 310.545(a)(8)(ii) 310.545(a)(22)(iv)
352.10(j) 352.10(k) 352.10(i) 310.545(a)(28)(ii)
NA I I
II I
III III II III II I I
FR Citation
310.545(a)(24)(i) 310.545(a)(3)(i) 310.545(a)(3)(i) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(12)(iv)(A) 310.545(a)(8)(i) 352.10(l) 341.20(b)(7)
OTC Active Ingredients
UNII Code K89MJ0S5VY K89MJ0S5VY 5UTX5635HP 5UTX5635HP 5UTX5635HP 61VUG75Y3P 61VUG75Y3P 4U7K4N52ZM 77FU10423X 77FU10423X Z11006CMUZ UA8U0KJM72 FQ3DRG0N5K FQ3DRG0N5K FQ3DRG0N5K WV9CM0O67Z WV9CM0O67Z WV9CM0O67Z WV9CM0O67Z 19F5HK2737 A236A06Y32 A236A06Y32 KU94FIY6JB KU94FIY6JB 3JJ4O33LAY 3JJ4O33LAY I9O0E3H2ZE 414P5USJ7F 68E52E5J67 58FMD0Q0EV SY49TH8VUA 89NA02M4RX 89NA02M4RX 89NA02M4RX 89NA02M4RX V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B
Active Ingredient oxymetazoline hydrochloride (aqueous) oxymetazoline hydrochloride (jelly) oxyquinoline oxyquinoline oxyquinoline oxyquinoline sulfate oxyquinoline sulfate oxytetracycline hydrochloride (combination only) padimate a (5 percent or higher) padimate a (up to 5 percent) padimate o pamabrom pancreatin pancreatin pancrelipase panthenol panthenol panthenol panthenol pantothenic acid papain papain papaya enzymes papaya, natural para-chloromercuriphenol para-chloromercuriphenol paraffin paregoric parethoxycaine hydrochloride parethoxycaine hydrochloride parsley passion flower extract pectin pectin pectin pectin peppermint peppermint oil peppermint oil peppermint oil peppermint oil
Monograph Sub-category cough/cold nasal decongestant cough/cold nasal decongestant antifungal antimicrobial oral health care antifungal skin protectant astringent first aid antibiotic ointment sunscreen sunscreen sunscreen menstrual/diuretic antihistamine digestive aid exocrine pancreatic insufficiency weight control digestive aid exocrine pancreatic insufficiency corn/callus remover external analgesic insect bite/sting external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac weight control digestive aid weight control weight control digestive aid antimicrobial diaper rash antimicrobial first aid antiseptic ophthalmic emollient antidiarrheal external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac menstrual/diuretic nighttime sleep aid antidiarrheal w/ sales less than $25,000 digestive aid external analgesic fever blister/cold sore oral health care demulcents digestive aid cough/cold antitussive cough/cold nasal decongestant cough/cold nasal decongestant cough/cold nasal decongestant
April 7, 2010
Panel I III
III II
I I I II/III II/III II
II
Pending I I III IIISE IIISE III I IISE IIISE I I I II I IISE
II II II II
I I
I III
II III
III
I
I
Final 341.20(b)(7) 341.20(b)(7) 310.545(a)(22)(ii)
FR Citation
310.545(a)(22)(ii) 310.545(a)(18)(ii) 333.120
352.10(m) 310.545(a)(8)(i) 310.545(a)(20) 310.545(a)(8)(i) [55 FR 33261] 310.545(a)(10)(vi) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(20) 310.545(a)(8)(i) 310.545(a)(20) 310.545(a)(20) 310.545(a)(8)(ii) 310.545(a)(27)(ii) 310.545(a)(27)(i) 349.14(b)(3) 310.545(a)(3)(i) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(24)(i) 310.545(a)(3)(ii) 310.545(a)(8)(ii) 310.545(a)(10)(v) 310.545(a)(8)(ii)
IIIE IIIE IIIE IIIE
[52 FR 30054] [59 FR 43408] [59 FR 43408] [59 FR 43408]
OTC Active Ingredients
UNII Code V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B V95R5KMY2B
367E55FXGW 367E55FXGW 367E55FXGW 367E55FXGW 4T6H12BN9U 4T6H12BN9U 4T6H12BN9U 4T6H12BN9U 4T6H12BN9U 70C1507JU9 ER0CTH01H9 ER0CTH01H9 ER0CTH01H9 ER0CTH01H9 28725X3PV8 28725X3PV8 NYW905655B NYW905655B YQE403BP4D 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV
Active Ingredient peppermint oil peppermint oil peppermint oil peppermint oil peppermint oil (mouthwash) peppermint oil and sage oil peppermint spirit peppermint spirit pepsin pepsin pepsin, essence Peruvian balsam peruvian balsam peruvian balsam oil peruvian balsam oil petrolatum petrolatum petrolatum petrolatum, white petrolatum, white phenacaine hydrochloride phenacetin phenacetin phenacetin phenacetin phenindamine tartrate phenindamine tartrate pheniramine maleate pheniramine maleate phenobarbital phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol
Monograph digestive aid external analgesic skin protectant skin protectant cough/cold gingivitis/plaque digestive aid menstrual/diuretic digestive aid weight control menstrual/diuretic anorectal skin protectant ophthalmic skin protectant anorectal ophthalmic skin protectant ophthalmic skin protectant anorectal digestive aid internal analgesic menstrual/diuretic weight control cough/cold menstrual/diuretic cough/cold internal analgesic cough/cold acne anorectal antifungal antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial
April 7, 2010
Sub-category insect bite/sting astringent insect bites/stings antihistamine
Panel III
Pending III
II
Final 310.545(a)(8)(i) 310.545(a)(10)(vi) 310.545(a)(18)(ii) 310.545(a)(18)(v)(A) 310.545(a)(6)(ii)(A)
IIIE
wound healing diaper rash diaper rash protectant emollient emollient anesthetic
antihistamine
II
II II
III(e,i)
III(e,i) IIIE I III I(e,i)
NA I I I II(e,i)
I I I II(e,i)
II
II
I
II I
antihistamine III miscellaneous antiseptic
II II(e,i) II
I III IIS II II(e,i) III I IIIE IIIE IIIE IIIE IIIE IIIE IIIE
310.545(a)(8)(ii) 310.545(a)(24)(i) 310.545(a)(8)(i) 310.545(a)(20) 310.545(a)(24)(i) 310.545(a)(26)(x)
346.14(a)(8) 349.14(b)(4) 347.10(m) 349.14(b)(6) 347.10(r) 310.545(a)(26)(vi) 310.545(a)(8)(ii) 310.545(a)(23)(i) 310.545(a)(24)(i) 310.545(a)(20) 341.12(i) 310.545(a)(24)(i) 341.12(j) 310.545(a)(23)(i) 310.545(a)(1) 310.545(a)(26)(ii) 310.545(a)(22)(ii)
FR Citation
OTC Active Ingredients
UNII Code 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 339NCG44TV 4NC0T56V35 4NC0T56V35 4NC0T56V35 4NC0T56V35 4NC0T56V35 4NC0T56V35 4NC0T56V35 6QK969R2IF YRC253429Q 28A37T47QO 28A37T47QO 28A37T47QO 28A37T47QO 28A37T47QO 28A37T47QO 47E5O17Y3R 27O3Q5ML57 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ
Active Ingredient phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenol phenolate sodium phenolate sodium phenolate sodium phenolate sodium phenolate sodium phenolate sodium phenolate sodium phenolphthalein phenoxyacetic acid phenyl salicyiate phenyl salicylate phenyl salicylate phenyl salicylate phenyl salicylate phenyl salicylate (salo) phenylalanine phenylephrine bitartrate (effervescent) phenylephrine hydrochloride phenylephrine hydrochloride phenylephrine hydrochloride phenylephrine hydrochloride phenylephrine hydrochloride (0.08 to 0.2%) phenylephrine hydrochloride (aqueous) phenylephrine hydrochloride (aqueous) phenylephrine hydrochloride (aqueous)
Monograph Sub-category antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial dandruff external analgesic oral health care anesthetic/analgesic relief of oral discomfort relief of oral discomfort skin protectant astringent skin protectant insect bites/stings skin protectant poison ivy/oak/sumac acne antifungal dandruff external analgesic oral health care anesthetic/analgesic relief of oral discomfort relief of oral discomfort laxative stimulant laxative corn/callus remover corn/callus remover acne antiemetic antifungal menstrual/diuretic antidiarrheal weight control cough/cold nasal decongestant anorectal vasoconstrictor cough/cold nasal decongestant ophthalmic vasoconstrictor oral health care ophthalmic vasoconstrictor cough/cold nasal decongestant cough/cold nasal decongestant cough/cold nasal decongestant
April 7, 2010
Panel
III I I
Pending IIISE IIS IIS IIS IIS IIS IIS IIS III I I I IIISE
II
II II III I I
III II II III III
III III I I I I
II III III I I I IIISE I IIIE II II II III
Final
310.545(a)(7)
310.545(a)(18)(ii) 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A) 310.545(a)(1) 310.545(a)(22)(ii) 310.545(a)(7)
310.545(a)(12)(iv)(B) [55 FR 33261] 310.545(a)(1)
I I III
310.545(a)(22)(ii) 310.545(a)(24)(i) 310.545(a)(3)(i) 310.545(a)(20) 341.20(a)(4) 346.12(d) 341.20(a)(1) 310.545(a)(21)(v)
I I I I
349.18(c) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8)
III II
FR Citation
oral
OTC Active Ingredients
UNII Code 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ 04JA59TNSJ OSX88361UX CG8692ZN14 CG8692ZN14 B48FTC099P 8D5I63UE1Q 8D5I63UE1Q 8D5I63UE1Q 8D5I63UE1Q 8UE48MJH8M 8UE48MJH8M 8UE48MJH8M 8UE48MJH8M 8UE48MJH8M 8UE48MJH8M 8UE48MJH8M
E4GA8884NN 27YLU75U4W 11E6VI8VEG ZLT174DL7U
63KP7FXF2I Q2RH0XR1MB LWK91TU9AH 58JV0P12FY 9C60Y73166 9C60Y73166 9C60Y73166 9C60Y73166
Active Ingredient Monograph Sub-category phenylephrine hydrochloride (aqueous) cough/cold nasal decongestant cough/cold nasal decongestant phenylephrine hydrochloride (jelly) cough/cold nasal decongestant phenylephrine hydrochloride (jelly) cough/cold nasal decongestant phenylephrine hydrochloride (jelly) phenylmercuric acetate vaginal contraceptive phenylmercuric nitrate antimicrobial first aid antiseptic phenylmercuric nitrate vaginal contraceptive phenylpropanolamine bitartrate cough/cold nasal decongestant phenylpropanolamine hydrochloride oral health care phenylpropanolamine hydrochloride weight control phenylpropanolamine hydrochloride (oral) cough/cold nasal decongestant phenylpropanolamine hydrochloride (topical) cough/cold nasal decongestant phenylpropanolamine maleate cough/cold nasal decongestant phenyltoloxamine citrate internal analgesic phenyltoloxamine citrate menstrual/diuretic antihistamine phenyltoloxamine dihydrogen citrate cough/cold antihistamine phenyltoloxamine dihydrogen citrate external analgesic poison ivy/oak/sumac phenyltoloxamine dihydrogen citrate internal analgesic phenyltoloxamine dihydrogen citrate nighttime sleep aid antihistamine phenyltoloxamine dihydrogen citrate skin protectant poison ivy/oak/sumac phenyltoloxamine hydrochloride cough/cold antihistamine phosphorated carbohydrate antiemetic phosphoric acid anticaries phosphorus weight control phytolacca weight control picrotoxin pediculicide pine tar dandruff expectorant pine tar preparations (extract white pine compound, pine tar, syrup of cough/cold pineapple enzymes weight control piperazine citrate anthelmintic piperocaine hydrochloride ophthalmic anesthetic piperonyl butoxide (combination) pediculicide pipsissewa menstrual/diuretic piscidia erythrina menstrual/diuretic botanical/vegetable herb plantago ovata husks laxative bulk laxative plantago seed laxative bulk laxative plantago seed weight control plantago seed husks [see psyllium seed husks ] laxative plantago seed, blond [see plantago seed] laxative podophyllum resin (podophyllin) laxative stimulant laxative poloxamer laxative stool softener
April 7, 2010
Panel I I I I
Pending I I I I IIS IIS
Final 341.20(b)(8) 341.20(b)(8) 341.20(b)(8) 341.20(b)(8) 310.545(a)(28)(i) 310.545(a)(27)(i) 310.545(a)(28)(i)
FR Citation
I III I/IIS I III I NA
IIIE III 310.545(a)(6)(i) 310.545(a)(10)(vii)
III III
III IISE
[54 FR 6826] 310.545(a)(18)(vi)(A) 310.545(a)(6)(i)
II
II III
II II II II
III NC II II II III III II IIS II II II I I III IISE IISE II III
310.545(a)(2)(ii) 310.545(a)(20) 310.545(a)(20) 310.545(a)(25)(i) 310.545(a)(7) 310.545(a)(6)(iii) 310.545(a)(20) [51 FR 27758] 310.545(a)(21)(i) 310.545(a)(25)(ii) 310.545(a)(24)(i) 310.545(a)(24)(i)
310.545(a)(20)
310.545(a)(12)(iv)(A) 310.545(a)(12)(iii)
OTC Active Ingredients
UNII Code LQA7B6G8JG TUF2IVW3M2
5655G9Y8AQ B697894SGQ 30IQX730WE 19371312D4
6OZP39ZG8H 532B59J990 M911911U02 HM5Z15LEBN HM5Z15LEBN OSD78555ZM BQN1B9B9HA BQN1B9B9HA BQN1B9B9HA H35KS68EE7 EE90ONI6FF GTP1P30292 TTK33Z47F1 1C4QK22F9J RU45X2JN0Z K91YT16P5M FZ989GH94E 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M
Active Ingredient poloxamer 188 poloxamer 407 poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex poloxamer-iodine complex polycarbophil polycarbophil polydimethylsiloxane and poloxamer polyethylene glycol 300 polyethylene glycol 400 polyethylene glycol 6000 polymyxin b sulfate (combination only) polyols, liquid polyoxeythylene laurate polysorbate 80 polyvinyl alcohol potassium acetate potassium bicarbonate potassium bicarbonate potassium bromide potassium carbonate potassium carbonate potassium carbonate potassium chlorate potassium citrate potassium ferrocyanide potassium guaiacolsulfonate potassium iodide potassium nitrate potassium salicylate povidone povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine
Monograph Sub-category antimicrobial relief of oral discomfort antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antidiarrheal w/ sales less than $25,000 laxative gingivitis/plaque ophthalmic demulcents ophthalmic demulcents ophthalmic demulcents first aid antibiotic ointment ophthalmic demulcents skin protectant astringent ophthalmic demulcents ophthalmic demulcents menstrual/diuretic antacid digestive aid nighttime sleep aid bromide antacid antidiarrheal w/ sales less than $25,000 digestive aid oral health care weight control skin protectant astringent cough/cold expectorant oral health care expectorant menstrual/diuretic internal analgesic ophthalmic demulcents acne antifungal antimicrobial antimicrobial antimicrobial antimicrobial
April 7, 2010
Panel
I
I I NA
Pending I IIIE IIISE IIISE IIISE IIISE IIISE IIISE IISE I I IIIE I I III I
II I I
I I
II
IISE
II
II IISE II
II III
Final
310.545(a)(3)(ii)
349.12(d)(2) 349.12(d)(3) 310.545(a)(21)(iv) 333.120 349.12(d) 310.545(a)(18)(ii) 349.12(d)(4) 349.12(e) 310.545(a)(24)(i) 331.11(j)(1) 310.545(a)(8)(ii) [54 FR 6826] 331.11(j)(1) 310.545(a)(3)(ii) 310.545(a)(8)(ii) 310.545(a)(20) 310.545(a)(18)(ii) 310.545(a)(6)(iii)
II 310.545(a)(24)(i) I III III
III I III I I IIISE IIISE IIISE
FR Citation
349.12(f) 310.545(a)(1) 333.210(d)
OTC Active Ingredients
UNII Code 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M 85H0HZU99M
88AYB867L5 88AYB867L5 88AYB867L5 88AYB867L5 70FD1KFU70 JHU490RVYR 6DC9Q167V3 6DC9Q167V3 LQU92IU8LL Z8IX2SC1OH
S8O01I9YLZ S8O01I9YLZ 6V9V2RYJ8N 6V9V2RYJ8N Y9DL7QPE6B Y9DL7QPE6B Y9DL7QPE6B 9C60Y73166 9C60Y73166
0462U14DUI 81BK194Z5M ZUM06L90GV ZUM06L90GV 68Y4CF58BV 68Y4CF58BV 68Y4CF58BV
Active Ingredient povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-iodine povidone-vinylacetate copolymers povidone-vinylacetate copolymers pramoxine hydrochloride pramoxine hydrochloride pramoxine hydrochloride pramoxine hydrochloride (combination) precipitated sulfur prolase propionic acid propylene glycol propylene glycol propylhexedrine propylparaben protease protein hydrolysate prune concentrate dehydrate prune powder pseudoephedrine hydrochloride pseudoephedrine hydrochloride pseudoephedrine sulfate pseudoephedrine sulfate pseudoephedrine sulfate (oral) psyllium (hemicellulose) [see plantago seed] psyllium hydrophilic mucilloid psyllium seed psyllium seed (blond) psyllium seed husks psylllium (hemicellulose) p-t-butyl-m-cresol pyrantel pamoate pyrethrum extract (combination) pyrethrum extract (combination) pyridoxine hydrochloride pyridoxine hydrochloride pyridoxine hydrochloride (vitamin B6)
Monograph antimicrobial antimicrobial antimicrobial antimicrobial dandruff oral health care external analgesic skin protectant anorectal external analgesic skin protectant anorectal anorectal digestive aid antifungal ophthalmic pediculicide cough/cold antifungal digestive aid skin protectant laxative laxative cough/cold cough/cold cough/cold cough/cold cough/cold laxative laxative laxative laxative laxative laxative skin protectant anthelmintic pediculicide pediculicide menstrual/diuretic skin protectant weight control
April 7, 2010
Sub-category
Panel
III poison ivy/oak/sumac poison ivy/oak/sumac local anesthetic
I(e),III(i) I
Pending IIISE IIISE IIISE IIISE III IIISE
I(e),III(i) I
Final
FR Citation
310.545(a)(7) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 346.10(g)
diaper rash keratolytic
demulcents nasal decongestant
diaper rash stimulant laxative stimulant laxative bronchodilator nasal decongestant bronchodilator nasal decongestant nasal decongestant
III(e),II(i) III(e),II(i) III I II I III
II I II I
bulk laxative astringent I aresol non-aresol vitamine fever blister/cold sore
I III
III I II I III III III III II I II I I IISE I I I I I I I I IIIE II
310.545(a)(26)(xi) 310.545(a)(26)(v) 310.545(a)(8)(ii) 310.545(a)(22)(ii) 349.12(d)(5) 310.545(a)(25)(i) 341.20(b)(9) 310.545(a)(22)(ii) 310.545(a)(8)(ii) 310.545(a)(18)(iii) 310.545(a)(12)(iv)(A) 310.545(a)(12)(iv)(A) 310.545(a)(6)(iv) 341.20(a)(2) 310.545(a)(6)(iv) 341.20(a)(3)
310.545(a)(18)(ii) 357.11 310.545(a)(25)(ii) 358.61 310.545(a)(18)(iv) 310.545(a)(20)
inhalant
oral oral
OTC Active Ingredients
UNII Code R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R35D29L3ZA R953O2RHZ5 R953O2RHZ6 R953O2RHZ7 R953O2RHZ8 A7V27PHC7A A7V27PHC7A 73JWT2K6T3 43SK4LAO7D 43SK4LAO7D 43SK4LAO7D 43SK4LAO7D
YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK YUL4LO94HK G280W4MW6E G280W4MW6E TLM2976OFR TLM2976OFR
Active Ingredient pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrilamine maleate pyrithione zinc pyrithione zinc pyrithione zinc pyrithione zinc quinine quinine racemethionine racephedrine hydrochloride racephedrine hydrochloride (oral/topical) racepinephrine hydrochloride racepinephrine hydrochloride red petrolatum reosote resorcinol resorcinol resorcinol resorcinol resorcinol resorcinol resorcinol resorcinol (as single ingredient only) resorcinol (when combined with sulfur) resorcinol monoacetate (as single ingredient only) resorcinol monoacetate (when combined with sulfur) rhubarb fluid extract rhubarb fluidextract rhubarb, Chinese riboflavin riboflavin rice polishings
Monograph Sub-category acne cough/cold antihistamine external analgesic insect bite/sting external analgesic poison ivy/oak/sumac internal analgesic menstrual/diuretic antihistamine nighttime sleep aid antihistamine oral health care anesthetic/analgesic skin protectant insect bites/stings skin protectant insect bites/stings skin protectant poison ivy/oak/sumac dandruff dandruff (wash-off) dandruff dandruff (leave-on) dandruff seborrheic dermatitis (wash-off) dandruff seborrheic dermatitis (leave-on) antimalarial internal analgesic skin protectant diaper rash cough/cold bronchodilator cough/cold nasal decongestant cough/cold bronchodilator cough/cold bronchodilator sunscreen relief of oral discomfort anorectal antiseptic anorectal keratolytic antifungal antimicrobial dandruff external analgesic skin protectant diaper rash acne acne acne acne digestive aid antidiarrheal w/ sales less than $25,000 laxative stimulant laxative menstrual/diuretic weight control weight control
April 7, 2010
Panel II I
Pending II I
III I III II
III IIISE IIISE II IISE
I I I I
I I I I
II
II III I I I I I I I I I IIISE III(e),II(i) III(e),II(i) I(e),II(i) I(e),II(i) II II IISE II II I I III
II
III
II
II
II III II II
Final 310.545(a)(1) 341.12(k) 310.545(a)(10)(vi) 310.545(a)(10)(vii) 310.545(a)(23)(i)
FR Citation
[54 FR 6826] 310.545(a)(14) 310.545(a)(18)(v)(A) 310.545(a)(18)(v)(A) 358.710(a)(2) 358.710(a)(3) 358.710(b)(2) 358.710(b)(3) 310.547 310.545(a)(23)(i) 310.545(a)(18)(iii) 341.16(f) 310.545(a)(6)(ii)(B) 341.16(g) 341.16(g) 310.545(a)(29)
inhalation rubber bulb
310.545(a)(26)(ii) 346.20(b) 310.545(a)(22)(ii) 310.545(a)(7)
310.545(a)(1) 333.310(b) 310.545(a)(1) 333.310(c) 310.545(a)(8)(ii) 310.545(a)(3)(ii) 310.545(a)(12)(iv)(A) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(20)
56 FR 63567
OTC Active Ingredients
UNII Code 6NAF1689IO FST467XS7D U27K0H1H2O FA1N0842KB EM8BM710ZC EM8BM710ZC EM8BM710ZC EM8BM710ZC EM8BM710ZC EM8BM710ZC O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ O414PZ4LPZ V9MO595C9I N9288CD508 J7WWH9M8QS 451IFR0GXB 451IFR0GXB Z69D9E381Q Z69D9E381Q Z69D9E381Q 5WS1632J8W AK7JF626KX AK7JF626KX S8SJ19N2NX
7Y1255HVXR 4B24275HEU
Active Ingredient sabadilla, alkaloids saccharin sage oil salicyl alcohol salicylamide salicylamide salicylamide salicylamide salicylamide salicylamide salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid salicylic acid (over 2 up to 5%) salsalate sanguinaria extract saw palmetto scopolamine aminoxide hydrobromide scopolamine hydrobromide scopolamine hydrobromide sea minerals selenium sulfide selenium sulfide selenium sulfide, micronized senecio aureus senna senna fluidextract senna pod concentrate senna syrup sennosides a and b sesame seed shark liver oil
Monograph Sub-category pediculicide weight control skin protectant astringent oral health care external analgesic analgesic & anesthetic external analgesic fever blister/cold sore external analgesic poison ivy/oak/sumac internal analgesic menstrual/diuretic nighttime sleep aid acne antifungal corn/callus remover collodoin-like vehicle corn/callus remover plaster vehicle dandruff dandruff dandruff psoriasis dandruff seborrheic dermatitis external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac wart remover collodoin-like vehicle wart remover karaya gum, glycol plaster vehicle wart remover plaster vehicle acne internal analgesic gingivitis/plaque menstrual/diuretic nighttime sleep aid scopolamine compound antidiarrheal nighttime sleep aid scopolamine compound weight control dandruff dandruff dandruff seborrheic dermatitis dandruff dandruff menstrual/diuretic botanical/vegetable herb digestive aid laxative laxative laxative laxative weight control anorectal wound healing
April 7, 2010
Panel II II I III III III III II III III I I I I I
I I III III
Pending II II I III III III IIISE IIISE IIE I III I I I I I
I I IISE III III IIIE
Final 310.545(a)(25)(i) 310.545(a)(20) 310.545(a)(18)(ii)
FR Citation
310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii)
[54 FR 6826] 333.310(d) 310.545(a)(22)(ii) 358.510(b) 358.510(a) 358.710(a)(4) 358.710(c)(2) 358.710(b)(4) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 358.110(b) 358.110(c) 358.110(a) 310.545(a)(1) 310.545(a)(23)(i) 310.545(a)(24)(i)
II II II I I I II
IIS II IIS II I I I II
III(e,i)
I/IIIS I/IIIS I/IIIS I II III(e,i)
[54 FR 6826] 310.545(a)(3)(i) [54 FR 6826] 310.545(a)(20) 358.710(a)(5) 358.710(b)(5) 358.710(a)(6) 310.545(a)(24)(i) 310.545(a)(8)(ii)
310.545(a)(20) 310.545(a)(26)(x)
OTC Active Ingredients
UNII Code 4B24275HEU 4B24275HEU 4B24275HEU 4B24275HEU 4B24275HEU 95IT3W8JZE TYU5GP6XGE TYU5GP6XGE TYU5GP6XGE TYU5GP6XGE 25K35WQ32Q
OJ245FE5EU 8MDF5V39QO 8MDF5V39QO 8MDF5V39QO 8MDF5V39QO 8MDF5V39QO 8MDF5V39QO 8MDF5V39QO 8MDF5V39QO 91MBZ8H3QO 91MBZ8H3QO 91MBZ8H3QO 91MBZ8H3QO 91MBZ8H3QO 91MBZ8H3QO 91MBZ8H3QO 91MBZ8H3QO LC1V549NOM LC1V549NOM 9XTM81VK2B 9XTM81VK2B 45P3261C7T 45P3261C7T
7473P66J9E 451W47IQ8X
Active Ingredient shark liver oil shark liver oil shark liver oil shark liver oil shark liver oil (combination only) silver nitrate simethicone simethicone simethicone simethicone sodium sodium 3, 4-dimethylphenyl-glyoxylate sodium acetylsalicylate (in solution) sodium aluminum chlorohydroxy lactate sodium benzoate sodium bicarbonate sodium bicarbonate sodium bicarbonate sodium bicarbonate sodium bicarbonate sodium bicarbonate sodium bicarbonate sodium bicarbonate sodium borate sodium borate sodium borate sodium borate sodium borate sodium borate sodium borate sodium borate monohydrate sodium bromide sodium bromide sodium caprylate sodium caprylate sodium carbonate sodium carbonate sodium carboxymethylcellulose sodium carboxymethylcellulose sodium caseinate sodium chloride
Monograph Sub-category Panel antimicrobial skin protectant insect bites/stings w/ sales less than $2 I I poison ivy/oak/sumac w/ sales less than skin protectant skin protectant w/ sales less than $25,000 I anorectal protectant I(e,i) skin protectant astringent II antiflatulent digestive aid antiflatulent III external analgesic poison ivy/oak/sumac skin protectant poison ivy/oak/sumac weight control sunscreen II overindulgence in a hangover reliever antiperspirant IIISE menstrual/diuretic antacid anticaries II digestive aid antacid III external analgesic gingivitis/plaque oral health care wound cleansing I skin protectant I weight control acne II antifungal III dandruff II external analgesic insect bite/sting oral health care skin protectant astringent II skin protectant insect bites/stings oral health care daytime sedative nighttime sleep aid bromide II antifungal III oral health care antacid anticaries antidiarrheal III laxative bulk laxative weight control digestive aid
April 7, 2010
Pending n/a I I I I(e,i) I I
II IISE I IIISE I II I n/a IIIE I NA III II II
Final
FR Citation
310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 346.14(b)(3) 310.545(a)(18)(ii) 332.10 [58 FR 54454] 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A) 310.545(a)(20) [64 FR 27682] 310.545(a)(4)(i) 310.545(a)(24)(i) 331.11(k)(1) 310.545(a)(8)(i)
347.10(o) 310.545(a)(20) 310.545(a)(1) 310.545(a)(22)(ii) 310.545(a)(7) 310.545(a)(10)(vi)
IISE 310.545(a)(18)(ii) 310.545(a)(18)(v)(A) IISE IISE IISE III IIIE I III I II
310.519(a) [54 FR 6826] 310.545(a)(22)(ii) 331.11(k)(1) 310.545(a)(2)(i)
310.545(a)(20) 310.545(a)(8)(ii)
OTC Active Ingredients
UNII Code 451W47IQ8X 451W47IQ8X 1Q73Q2JULR 1Q73Q2JULR 1Q73Q2JULR 1Q73Q2JULR 26WJH3CS0B 3980JIH2SW 8ZYQ1474W7 8ZYQ1474W7 8ZYQ1474W7 8ZYQ1474W7 8ZYQ1474W7 8ZYQ1474W7 8ZYQ1474W7 C810JCZ56Q C810JCZ56Q C810JCZ56Q C810JCZ56Q C810JCZ56Q 8M4L3H2ZVZ 399SL044HN 75UI7QUZ5J Y52BK1W96C Y9UKD0XE6F SE337SVY37 SE337SVY37 SE337SVY37 SE337SVY37 QH257BPV3J QH257BPV3J DK6Y9P42IN DK6Y9P42IN WIQ1H85SYP WIQ1H85SYP WIQ1H85SYP WIQ1H85SYP WIQ1H85SYP WIQ1H85SYP
Active Ingredient Monograph Sub-category sodium chloride ophthalmic hypertonic agent sodium chloride (salt) weight control sodium citrate cough/cold expectorant sodium citrate digestive aid antacid sodium citrate relief of oral discomfort sodium citrate in solution overindulgence in a hangover reliever/overindulgence sodium diacetate skin protectant astringent sodium dichromate oral health care sodium dihydrogen phosphate anticaries sodium dihydrogen phosphate monohydrate anticaries sodium fluoride relief of oral discomfort sodium fluoride relief of oral discomfort sodium fluoride (aqueous) anticaries sodium fluoride (aqueous) (acidulated phosphate fluoride with .01% fl anticaries sodium fluoride (aqueous) (acidulated phosphate fluoride with .02% fl anticaries sodium fluoride gel or paste anticaries dentifrices sodium fluoride powder anticaries dentifrices sodium monofluorophosphate anticaries sodium monofluorophosphate (rinse) anticaries sodium monolfuorophosphate relief of oral discomfort sodium monolfuorophosphate (gel or paste) anticaries dentifrices sodium monolfuorophosphate (gel or paste) anticaries dentifrices sodium nitrate menstrual/diuretic sodium oleate laxative stimulant laxative sodium para-aminobenzoate internal analgesic sodium perborate oral health care sodium perborate monohydrate oral health care wound cleansing sodium phosphate anticaries sodium phosphate anticaries sodium phosphate, dibasic laxative saline laxative sodium phosphate, monobasic laxative saline laxative sodium potassium tartrate antacid sodium potassium tartrate antacid sodium propionate antifungal sodium propionate antimicrobial sodium salicylate dandruff sodium salicylate digestive aid sodium salicylate internal analgesic sodium salicylate menstrual/diuretic analgesic sodium salicylate overindulgence in alcohol/food sodium salicylic acid phenolate anorectal antiseptic
April 7, 2010
Panel I
III
Pending I II III I IIIE I
Final 349.16 310.545(a)(20) 310.545(a)(6)(iii) 310.545(a)(8)(i)
310.545(a)(18)(ii) II II
I/NC NC I I I II I
II II II II
III III I I II(e,i)
IISE NC NC IIIE IISE I I I I I II IIIE I I III II IIISE I NC NC I I I I III IIISE III
310.545(a)(2)(ii) 310.545(a)(2)(ii)
355.10(a)(3)(iii)-(v)
355.10(a)(1) 355.10(a)(2) 310.545(a)(2)(i)
355.10(b)(1) 355.10(b)(2) 310.545(a)(24)(i) 310.545(a)(12)(iv)(A) 310.545(a)(23)(i)
310.545(a)(2)(i) 310.545(a)(2)(ii)
331.11(j)(2) 331.11(k)(2) 310.545(a)(22)(ii) 310.545(a)(7) 310.545(a)(8)(ii)
I I II(e,i)
310.545(a)(26)(ii)
FR Citation
OTC Active Ingredients
UNII Code C02T02993U HX1032V43M 451IFR0GXB 506T60A25R 506T60A25R 506T60A25R 241ATL177A R44IWB3RN5 3629601H5D 3FTR44B32Q 3FTR44B32Q 3FTR44B32Q 3FTR44B32Q 3FTR44B32Q 2KR89I4H1Y 2KR89I4H1Y 2KR89I4H1Y ZLM4P8929R 4J2TY8Y81V 5R78837D4A 5R78837D4A H9Y79VD43J 70FD1KFU70 C151H8M554 C151H8M554 4NRT660KJQ 70FD1KFU70 70FD1KFU70 70FD1KFU70 70FD1KFU70 70FD1KFU70 70FD1KFU70 70FD1KFU70 70FD1KFU70 70FD1KFU70 1W6L629B4K 7SEV7J4R1U
Active Ingredient sodium sulfide (aqueous) sodium thiosulfate soopolamine hydrobromide sorbitol sorbitol sorbitol soy meal soybean oil, hydrogenated (powder) soybean protein squill preparations (squill, squill extract) stannous fluoride stannous fluoride stannous fluoride stannous fluoride (gel) stannous fluoride (rinse) stannous pyrophosphate and zinc citrate stearyl alcohol stearyl alcohol stearyl alcohol stem bromelain strawberry strontium chloride strontium chloride strychnine sublimed sulfur sucrose sucrose sugars sulfacetamide sodium sulferated oils of turpentine sulfur sulfur sulfur sulfur sulfur sulfur sulfur sulfur (when combined w/ resorcinol, resocinol monoacetate) sulfur, sublimed sulisobenzone talc
Monograph Sub-category Panel Pending ingrown toenail gel vehicle I acne II II antiemetic III digestive aid II II laxative hyperosmotic I oral health care demulcents III weight control II cholecystokinetic weight control II cough/cold expectorant II anticaries dentifrices I I anticaries dentifrices I I relief of oral discomfort IIIE anticaries I I anticaries I I gingivitis/plaque IIIE skin protectant insect bites/stings w/ sales less than $25,000 skin protectant poison ivy/oak/sumac w/ sales less than $25,000 skin protectant w/ sales less than $25,000 digestive aid digestive aid relief of oral discomfort IIIE relief of oral discomfort IISE digestive aid anorectal keratolytic III(e),II(i) III(e),II(i) menstrual/diuretic weight control II oral health care demulcents III ophthalmic anti-infective II II menstrual/diuretic acne I I antifungal III dandruff dandruff I I external analgesic poison ivy/oak/sumac skin protectant diaper rash II skin protectant fever blister/cold sore II II skin protectant II II acne I I pediculicide II II sunscreen I I skin protectant astringent II
April 7, 2010
Final 538.31 310.545(a)(1) 310.545(a)(8)(i) 310.545(a)(14) 310.545(a)(20) 357.210(b) 310.545(a)(20) 310.545(a)(6)(iii) 355.10(c)(1)(i) 355.10(c)(1)(ii) 355.10(c)(2) 355.10(c)(3) 310.545(a)(18)(v)(B) 310.545(a)(18)(vi)(B) 310.545(a)(18)(i)(B) 310.545(a)(8)(ii) 310.545(a)(8)(ii)
310.545(a)(8)(ii) 310.545(a)(26)(v) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(14) 310.545(a)(24)(i) 333.310(e) 310.545(a)(22)(ii) 358.710(a)(7) 310.545(a)(10)(vii) 310.545(a)(18)(iii) 310.545(a)(18)(iv) 310.545(a)(18)(i)(A) 333.310(f) 310.545(a)(25)(i) 352.10(o) 310.545(a)(18)(ii)
FR Citation
OTC Active Ingredients
UNII Code 7SEV7J4R1U 7SEV7J4R1U 28F9E0DJY10 28F9E0DJY11 28F9E0DJY12 28F9E0DJY13 28F9E0DJY14 28F9E0DJY14 28F9E0DJY6 28F9E0DJY7 28F9E0DJY8 28F9E0DJY9 28F9E0DJY15 W4888I119H
0619F35CGV 0619F35CGV 0619F35CGV 5NF5D4OPCI 5NF5D4OPCI 5NF5D4OPCI 5NF5D4OPCI 5NF5D4OPCI 0YZT43HS7D M572600E5P 8K0I04919X 7ZQC1892H9 7ZQC1892H9 7ZQC1892H9 C137DTR5RG C137DTR5RG
0I55128JYK M572600E5P M572600E5P 2225PI3MOV
Active Ingredient talc talc tannic acid tannic acid tannic acid tannic acid tannic acid tannic acid tannic acid tannic acid tannic acid tannic acid tannic acid glycerite taraxacum officinale tartaric acid tartrate (acid or salt) terpin hydrate prearations (terpin hydrate, terpin hydrate elixer) tetracaine tetracaine tetracaine tetracaine hydrochloride tetracaine hydrochloride tetracaine hydrochloride tetracaine hydrochloride tetracycline hydrochloride tetrahydrozoline hydrochloride thaimine hydrochloride (vitamin B1) thaimine mononitrate (vitamine B1 mononitrate) thenyldiamine hydrochloride thenyldiamine hydrochloride thenyldiamine hydrochloride theobromine sodium salicylate theophylline theophylline (in combination) theophylline calcium salicylate theophylline sodium glycinate theophylline, anhydrous thiamine hydrochloride thiamine hydrochloride thimerosal thiocyanoacetate
Monograph skin protectant skin protectant external analgesic skin protectant skin protectant skin protectant skin protectant skin protectant anorectal antifungal digestive aid external analgesic skin protectant menstrual/diuretic laxative antacid cough/cold anorectal external analgesic oral health care acne anorectal external analgesic oral health care first aid antibiotic ophthalmic weight control weight control cough/cold cough/cold cough/cold menstrual/diuretic menstrual/diuretic cough/cold cough/cold cough/cold cough/cold menstrual/diuretic nighttime sleep aid antimicrobial pediculicide
Sub-category astringent diaper rash poison ivy/oak/sumac diaper rash fever blister/cold sore poison ivy/oak/sumac diaper rash wound healing astringent
fever blister/cold sore astringent botanical/vegetable herb saline laxative expectorant local anesthetic analgesic & anesthetic anesthetic/analgesic local anesthetic anesthetic/analgesic ointment vasoconstrictor
antihistamine nasal decongestant nasal decongestant antihistamine antihistamine bronchodilator bronchodilator bronchodilator bronchodilator
April 7, 2010
Panel II
II II II II II(e,i) II
II II
Pending IISE I II II II II II II(e,i)
II
III III III III III
I III I(e),III(i) I II II I(e),III(i) I II I I II II III III IIIE III III
I I I
II II II
II
II
II
II
III(e,i) I II II III(e,i) I II I
first aid antiseptic
Final 310.545(a)(18)(ii)
FR Citation
310.545(a)(10)(vii) 310.545(a)(18)(iii) 310.545(a)(18)(iv) 310.545(a)(18)(vi)(A) 310.545(a)(18)(iii) 310.545(a)(18)(i)(A) 310.545(a)(26)(iii) 310.545(a)(22)(ii) 310.545(a)(8)(ii) 310.545(a)(10)(v) 310.545(a)(18)(ii) 310.545(a)(24)(i) 310.545(a)(12)(ii) 331.11(m) 310.545(a)(6)(iii) 346.10(h) pending 310.545(a)(14) 310.545(a)(1) 346.10(i) 310.545(a)(14) 333.110(f) 349.18(d) 310.545(a)(20) 310.545(a)(20) 310.545(a)(6)(i) 310.545(a)(6)(ii)(A) [59 FR 43408] 310.545(a)(24)(i) 310.545(a)(24)(i) 310.545(a)(6)(iv)(B) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 310.545(a)(6)(iv) 310.545(a)(24)(i) 310.545(a)(27)(i) 310.545(a)(25)(i)
OTC Active Ingredients
UNII Code 6K9YKD48Y4 2ZD004190S 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 3J50XA376E 15FIX9V2JP 5236RK32KG 06KB629TKV TD2LE91MBE TD2LE91MBE 08232NY3SJ O8232NY3SJ O8232NY3SJ O8232NY3SJ O8232NY3SJ O8232NY3SJ O8232NY3SJ O8232NY3SJ XHX3C3X673 K4C08XP666 K4C08XP666 BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y BGG1Y1ED0Y
Active Ingredient thonzylamine hydrochloride threonine thymol thymol thymol thymol thymol thymol thymol thymol thymol thymol thymol thymol (lozenge) thymol (mouthwash) thymol iodide thymol iodide thymol iodide titanium dioxide tolindate tolnaftate tolu balsam tolu preparations (tolu, tolu balsalm, tolu balsalm tincture) topical starch topical starch topical starch topical starch topical starch topical starch topical starch topical starch triacetin tricalcium phosphate tricalcium phosphate triclocarban triclocarban triclocarban triclocarban triclocarban triclocarban triclocarban
Monograph Sub-category cough/cold antihistamine weight control acne antifungal cough/cold nasal decongestant dandruff external analgesic analgesic & anesthetic external analgesic fever blister/cold sore external analgesic poison ivy/oak/sumac oral health care anesthetic/analgesic relief of oral discomfort relief of oral discomfort skin protectant astringent cough/cold nasal decongestant cough/cold nasal decongestant oral health care relief of oral discomfort relief of oral discomfort sunscreen antifungal antifungal oral health care cough/cold expectorant anorectal protectant external analgesic skin protectant astringent skin protectant diaper rash skin protectant fever blister/cold sore skin protectant poison ivy/oak/sumac skin protectant skin protectant antifungal antacid weight control antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial
April 7, 2010
Panel I II II III III III III III III
II III III
I II I III I(e,i)
Pending I II III III III III III III III IIIE IIIE III III IIISE IIIE IIIE I II I III I(e,i) IISE
II
Final 341.12(l) 310.545(a)(20) 310.545(a)(1) 310.545(a)(22)(ii) 310.545(a)(6)(ii)(A) 310.545(a)(7) 310.545(a)(10)(i) 310.545(a)(10)(v) 310.545(a)(10)(vii) 310.545(a)(14)
310.545(a)(18)(ii) 310.545(a)(6)(ii)(A) 310.545(a)(6)(ii)(A)
352.10(p) 310.545(a)(22)(ii) 333.210(e) 310.545(a)(6)(iii) 346.14(a)(9) 310.545(a)(18)(ii)
I
III
I IIISE III II IIIE IIISE IIISE IIISE IISE IISE IISE
310.545(a)(18)(iv) 310.545(a)(18)(vi)(A) 347.10(q) 310.545(a)(18)(iv) 310.545(a)(22)(ii) 331.11(i)(3) 310.545(a)(20)
FR Citation
OTC Active Ingredients
UNII Code BGG1Y1ED0Y 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X 4NM5039Y5X FWV8GJ56ZN FWV8GJ56ZN
YAN7R5L890 8K1MK5E1FY 9O3K93S3TK 9O3K93S3TK 9O3K93S3TK 9O3K93S3TK H8O4040BHD H8O4040BHD H8O4040BHD H8O4040BHD 8DUH1N11BX XJ6RUH0O4G XJ6RUH0O4G XJ6RUH0O4G XJ6RUH0O4G XJ6RUH0O4G XJ6RUH0O4G XJ6RUH0046 XJ6RUH0O4G XJ6RUH0O4G
Active Ingredient triclocarban triclosan triclosan triclosan triclosan triclosan triclosan triclosan triclosan triclosan trillium tripelennamine hydrochloride tripelennamine hydrochloride triple dye triple dye triple dye triple dye triple dye triple dye triple dye triple dye triprolidine hydrochloride triticum trolamine trolamine trolamine trolamine trolamine salicylate trolamine salicylate (triethanolamine salicylate) trolamine salicylate (trietnanolamine salicylate) trolamine salicylate (trietnanolamine salicylate) tryptophan turpentine oil turpentine oil turpentine oil turpentine oil turpentine oil turpentine oil (oral) turpentine oil (rectified) turpentine oil (spirits of turpentine) turpentine oil (spirits of turpentine) (oral)
Monograph antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial digestive aid external analgesic external analgesic antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial cough/cold menstrual/diuretic external analgesic skin protectant skin protectant skin protectant sunscreen external analgesic external analgesic external analgesic weight control external analgesic external analgesic external analgesic skin protectant skin protectant cough/cold anorectal cough/cold cough/cold
April 7, 2010
Sub-category
Panel
fever blister/cold sore
antihistamine II
Pending IISE IIIE IIISE IIISE IIISE IIISE IIISE IIISE IIISE IIISE I I IIISE IIISE IIISE IISE IISE IISE IISE IISE I II IISE
fever blister/cold sore insect bites/stings poison ivy/oak/sumac fever blister/cold sore insect bite/sting poison ivy/oak/sumac fever blister/cold sore insect bite/sting poison ivy/oak/sumac insect bites/stings poison ivy/oak/sumac antitussive counterirritant expectorant nasal decongestant
I III III III I
I III III III II I
III II(e,i)
IISE II(e,i)
II
II
Final
310.545(a)(8)(ii) 310.545(a)(10)(v)
341.12(m) 310.545(a)(24)(i) 310.545(a)(18)(iv) 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A) 352.10(q) 310.545(a)(10)(v) 310.545(a)(10)(vi) 310.545(a)(10)(vii) 310.545(a)(20) 310.545(a)(10)(v) 310.545(a)(10)(vi) 310.545(a)(10)(vii) 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A) 310.545(a)(26)(iv) 310.545(a)(6)(iii) 310.545(a)(6)(ii)(A)
FR Citation
OTC Active Ingredients
UNII Code XJ6RUH0O4G XJ6RUH0O4G AD8LJ73GQF 42HK56048U
K3D86KJ24N K3D86KJ24N 8W8T17847W 3M5V3D1X36 HG18B9YRS7 9ZP99WL196 81G40H8B0T 81G40H8B0T 81G40H8B0T 81G40H8B0T
H4N855PNZ1 H4N855PNZ1 H4N855PNZ1 H4N855PNZ1
059QF0KO0R 7G1J5DA97F 2ZA36H0S2V YR3G369F5A 4T6H12BN9U 101I4J0U34 1014J0U34 N8C4A9A49H TTV12P4NEE X5S84033NZ
Active Ingredient turpentine oil (spirits of turpentine) (topical) turpentine oil (topical/inhalant) turpentine, venice (venice turpentine) tyrosine undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecoylium chlorideiodine complex undecylenic acid undecylenic acid urea uva ursi, extract of uva ursi, potassium extract valine vegetable (green) vitamin A vitamin A vitamin A vitamin A vitamin A acetate vitamin A palmitate vitamin E vitamin E vitamin E vitamin E vitromersol water and additives water, purified wax, white wax, yellow wheat germ white ointment white petrolatum witch hazel witch hazel (haramelis water) woodruff xanthan gum xylometazoline hydrochloride (aqueous)
Monograph Sub-category cough/cold nasal decongestant cough/cold antitussive menstrual/diuretic weight control antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antimicrobial antifungal dandruff menstrual/diuretic menstrual/diuretic weight control weight control weight control anorectal wound healing corn/callus remover skin protectant diaper rash weight control weight control weight control acne nighttime sleep aid stimulant weight control antimicrobial first aid antiseptic ophthalmic ophthalmic ophthalmic emollient ophthalmic emollient weight control ophthalmic emollient anorectal protectant skin protectant astringent anorectal astringent digestive aid weight control cough/cold nasal decongestant
April 7, 2010
Panel III III
I III II
III(e,i) II
II
Pending III IIIE II IIIE IIISE IIISE IIISE IIISE IIISE IISE I III II II II II III(e,i) IISE IIISE II II II II II IIE II
Final 310.545(a)(6)(ii)(A)
[52 FR 30055] 310.545(a)(24)(i) 310.545(a)(20)
333.210(f) 310.545(a)(7) 310.545(a)(24)(i) 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(26)(x) [55 FR 33261] 310.545(a)(20) 310.545(a)(20) 310.545(a)(20) 310.545(a)(1) [39 FR 6104] 310.545(a)(20) 310.545(a)(27)(i)
I I NA I I(e,i) I I(e)
I I II I I(e,i) I I(e) III I
FR Citation
349.20 349.14(b)(7) 349.14(b)(8) 310.545(a)(20) 349.14(b)(5) 346.14(a)(10) 347.12(c) 346.18(b) 310.545(a)(8)(ii) 310.545(a)(20) 341.20(b)(10)
OTC Active Ingredients
UNII Code X5S84033NZ X5S84033NZ X5S84033NZ 3NY3SM6B8U 3NY3SM6B8U 3NY3SM6B8U IY191986AO FM5526K07A FM5526K07A FM5526K07A FM5526K07A QL5435GI2S EQR32Y7H0M EQR32Y7H0M 86Q357L16B 86Q357L16B 86Q357L16B K72I3DEX9B SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z SOI2LOH54Z 4O71YT5YB5 4O71YT5YB5 4O71YT5YB5 4O71YT5YB5 H92E6QA4FV H92E6QA4FV 89DS0H96TB 89DS0H96TB 89DS0H96TB 89DS0H96TB 89DS0H96TB 89DS0H96TB 388VZ25DUR
Active Ingredient xylometazoline hydrochloride (aqueous) xylometazoline hydrochloride (jelly) xylometazoline hydrochloride (jelly) yeast yeast cell derivative, live yeast cell derivative, live yellow mercuric oxide zinc acetate zinc acetate zinc acetate zinc acetate zinc caprylate zinc carbonate zinc carbonate zinc chloride zinc chloride zinc chloride zinc citrate zinc oxide zinc oxide zinc oxide zinc oxide zinc oxide zinc oxide zinc oxide zinc oxide zinc oxide (combination only) zinc phenol sulfonate zinc phenolsulfonate zinc phenolsulfonate zinc phenolsulfonate zinc propionate zinc stearate zinc stearate zinc sulfate zinc sulfate zinc sulfate zinc sulfate zinc sulfate zinc sulfide zinc undecylenate
Monograph Sub-category cough/cold nasal decongestant cough/cold nasal decongestant cough/cold nasal decongestant weight control skin protectant diaper rash skin protectant wound healing agent ophthalmic anti-infective external analgesic skin protectant diaper rash skin protectant wound healing agent skin protectant antifungal skin protectant diaper rash skin protectant corn/callus remover oral health care skin protectant astringent gingivitis/plaque acne anorectal astringent external analgesic insect bite/sting external analgesic n/a skin protectant astringent skin protectant sunscreen anorectal protectant sunscreen antidiarrheal antiemetic skin protectant astringent antifungal acne skin protectant astringent external analgesic fever blister/cold sore ophthalmic astringent poison treatment skin protectant astringent skin protectant fever blister/cold sore acne antifungal
April 7, 2010
Panel I I
III
I I III I III I II II I(e,i)
II I I(e,i)
Pending I I I II IIIE IIISE II IISE III I I III III I IIIE I
Final 341.20(b)(10) 341.20(b)(10) 341.20(b)(10) 310.545(a)(20)
FR Citation
310.545(a)(18)(i)(B) 310.545(a)(21)(ii) 310.545(a)(18)(iii) 310.545(a)(18)(i)(A) 347.10(s) 310.545(a)(22)(ii) 310.545(a)(18)(iii) 347.10(t) [55 FR 33261] 310.545(a)(18)(ii)
IIIE II I(e,i) IISE I II I III I(e,i)
310.545(a)(1) 346.18(c) 310.545(a)(10)(vi) 352.10(r) 310.545(a)(18)(ii) 347.10(u) 352.10(r) 346.14(b)(4) [64 FR 27682]
III II III II II I
III II III II
I II
II II I
II I
310.545(a)(3)(i) 310.545(a)(18)(ii) 310.545(a)(22)(ii) 310.545(a)(1) 310.545(a)(18)(ii) 310.545(a)(10)(v) 349.10 310.545(a)(16) 310.545(a)(18)(ii) 310.545(a)(18)(iv) 310.545(a)(1) 333.210(f)
OTC Active Ingredients
UNII Code
Active Ingredient zirconium oxide zirconium oxide zirconium oxide zirconium oxide zyloxin zyloxin zyloxin
Monograph external analgesic external analgesic skin protectant skin protectant antimicrobial external analgesic skin protectant
Sub-category insect bite/sting poison ivy/oak/sumac insect bites/stings poison ivy/oak/sumac first aid antiseptic poison ivy/oak/sumac poison ivy/oak/sumac
April 7, 2010
Panel
Pending
Final 310.545(a)(10)(vi) 310.545(a)(10)(vii) 310.545(a)(18)(v)(A) 310.545(a)(18)(vi)(A) 310.545(a)(27)(i) 310.545(a)(10)(vii) 310.545(a)(18)(vi)(A)
FR Citation