FDA-2013-N-1524 Non USP Monographed And/Or Non FDA Approved Drug Substances
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25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances CAS Dose Recognition in Bibliographies on Safety and Ingredient Name Chemical Name UNII Code Number Format Pharmacopeias Efficacy Data 2-ethylhexyl-4- 2-ethylhexyl-4- 93NOD9WBCS sunscreen phenylbenzophenone-2- phenylbenzophenone-2- carboxylic acid carboxylic acid 4-Aminopyridine 4-AP; Fampridine; 504-24-5 Reagent Federal Register 1999 Dalfampridine 5-Hydroxytryptophan (L) Oxitriptan; L-Tryptophan? 9/8/4350; 73- Powder USP 22-3 Page 1 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances 7-Keto Dehydroepiandrosterone, 7-Keto DHEA 566-19-8 Powder Not USP Micronized 8-Methoxypsoralen 8-MOP; Methoxsalen? 298-81-7 USP if correct stuff Acacia Gum, Spray-Dried Powder Acacia Gum, Spray-Dried ? NF, FCC Powder Acacia Syrup Acacia Syrup NF Acepromazine Maleate Acepromazine Maleate 61-00-7 USP Acesulfame Potassium Acesulfame Potassium 55589-62-3 NF, FCC acetaminophen acetaminophen 362O9ITL9D USP, USPMC internal analgesic acetaminophen acetaminophen 362O9ITL9D USP, USPMC menstrual/diuretic analgesic acetaminophen acetaminophen 362O9ITL9D USP, UPSMC nighttime sleep aid acetaminophen acetaminophen 362O9ITL9D USP, USPMC overindulgence in a hangover reliever Acetaminophen Paracetamol 103-90-2 Powder USP Acetaminophen, 60 Mesh Paracetamol 103-90-2 Powder USP acetanilide acetanilide SP86R356CC Not in USPNF, FCC or USPMC internal analgesic Page 2 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances acetaZOLAMIDE Acetazolamide 59-66-5 Tablet, Powder USP Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, OH. Lexi-Comp, Inc. 2010: 41-43. acetic acid acetic acid Q40Q9N063P NF otic acetic acid acetic acid Q40Q9N063P NF wart remover Acetic Acid, 3% (w/v) Aqueous Acetic Acid, 3% (w/v) Not USP Solution Aqueous Solution Acetic Acid, 5% (w/v) Aqueous Acetic Acid, 5% (w/v) Liquid USP has a monograph for Otic Solution Aqueous Solution Solution Acetic Acid, Glacial Acetic Acid, Glacial USP acetic acid, glacial acetic acid, glacial Q40Q9N063P USP, FCC corn/callus remover acetic acid, glacial acetic acid, glacial Q40Q9N063P USP, FCC wart remover Acetone Dimethylformaldehyde, 2- 67-64-1 Liquid USP Reagents A list for Acetone Propanone acetone acetone 1364PS73AF USP, FCC skin protectant astringent Page 3 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances Acetone Sodium Bisulfite 2-Hydroxy-2- 540-92-1 Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, propanesulfonic acid, name eds. Handbook of Pharmaceutical Excipients. sodium salt 7th ed. London, UK. Pharmaceutical Press div Royal Pharmaceutical Society of Great Britain and Washington, DC. American Pharmacists Association; 2012. Acetyl glucosamine Glucosamine Hydrochloride? 66-84-2? USP if correct stuff Acetyl Hexapeptide-3 Acetyl Hexapeptide-3 Not USP unless by another name Acetylcysteine Acetylcysteine 616-91-1 Oral or USP Morgan DL, Borys DJ. Chapter 45. Poisoning. Inhalation In: Stone CK, Humphries RL, eds. CURRENT solution, Diagnosis & Treatment: Emergency powder Medicine. 6th ed. New York: McGraw-Hill; 2011. Acetylcysteine Acetylcysteine 616-91-1 Oral or USP Morgan DL, Borys DJ. Chapter 45. Poisoning. Inhalation In: Stone CK, Humphries RL, eds. CURRENT solution, Diagnosis & Treatment: Emergency powder Medicine. 6th ed. New York: McGraw-Hill; 2011. Acetyl-L-Carnitine Hydrochloride 2-(acetyloxy)-3-carboxy- 5080-50-2 powder Not USP unless by another N,N,N-trimethyl-, chloride, ®- name 1-propanaminiu; Acetyl-L- Carnitine Acidophilus Lactobacillus Acidophilus Lactobacillus Powder Not USP, FCC? Active Ingredient Chemical Name CAS Number UNII Code Dose Format Pharmacopeia Recognition Monograph and Sub-category Adenosine-5-triphosphate Adenosine? 58-61-7? On Negative list? USP if right disodium salt name and CAS. agar agar USP, FCC laxative bulk laxative Page 4 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances Alanine Alanine; L-Alanine 56-41-7 USP alcloxa alcloxa 18B8O9DQA2 Not in USPNF, FCC or USPMC acne alcloxa alcloxa 18B8O9DQA2 Not in USPNF, FCC or USPMC anorectal keratolytic alcloxa alcloxa 18B8O9DQA2 Not in USPNF, FCC or USPMC antifungal Alcohol Ethanol; Ethyl Alcohol 64-17-5 Liquid USP, BP alcohol alcohol 3K9958V90M USP digestive aid alcohol alcohol 3K9958V90M USP external analgesic insect bite/sting alcohol alcohol 3K9958V90M USP external analgesic poison ivy/oak/sumac alcohol alcohol 3K9958V90M USP menstrual/diuretic alcohol alcohol 3K9958V90M USP oral heath care Page 5 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances alcohol alcohol 3K9958V90M USP skin protectant alcohol alcohol 3K9958V90M USP skin protectant astringent alcohol alcohol 3K9958V90M USP skin protectant insect bites/stings alcohol alcohol 3K9958V90M USP skin protectant poison ivy/oak/sumac alcohol alcohol 3K9958V90M USP weight control alcohol alcohol 3K9958V90M USP mercury alcohol, ethoxylated alkyl alcohol, ethoxylated alkyl 3K9958V90M external analgesic insect bite/sting alcohol, ethoxylated alkyl alcohol, ethoxylated alkyl 3K9958V90M skin protectant insect bites/stings aldioxa aldioxa 8T66I31YNK Not in USPNF, FCC or USPMC skin protectant diaper rash Aldosterone Aldosterone Not USP Page 6 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances alfalfa alfalfa SQI2NBY9KR Not in USPNF, FCC or USPMC weight control alfalfa leaves alfalfa leaves SQI2NBY9KR Not in USPNF, FCC or USPMC menstrual/diuretic alginic acid alginic acid 8C3Z4148WZ NF weight control Aliphatic Polyesters Numerous: Poly(DL-lactide- Not USP unless by another Rowe RC, Sheskey PJ, Cook WG, Quinn ME, co-glycolide)(100:0), (85:15), name eds. Handbook of Pharmaceutical Excipients. 975:25), (65:35), and 7th ed. London, UK. Pharmaceutical Press div Numerous at (50:50); Poly(L- Royal Pharmaceutical Society of Great Britain lactide), Poly(glycolide), Poly- and Washington, DC. American Pharmacists e-caprolactone Association; 2012. Alitame Aclame; L-aspartyl-D-alanine-80863-62-3 USP Rowe RC, Sheskey PJ, Cook WG, Quinn ME, N-(2,2,4,4- (anhydrous) eds. Handbook of Pharmaceutical Excipients. tetramethylthietan-3-yl)a- and 99016-42- 7th ed. London, UK. Pharmaceutical Press div mide; 3-(L-aspartyl-D- 9 (hydrate) Royal Pharmaceutical Society of Great Britain alaninamido)-2,2,4,4- and Washington, DC. American Pharmacists tetramethylthietane Association; 2012. alkyl dimethyl amine oxide and alkyl dimethyl amine oxide gingivitis/plaque aklyl dimethyl glycine and aklyl dimethyl glycine alkyl isoquinolinium bromide alkyl isoquinolinium bromide acne Page 7 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances Allantoin Allantoin 97-59-6 USP allantoin allantoin 344S277G0Z USP dandruff analgesic allantoin allantoin 344S277G0Z USP external analgesic allantoin allantoin 344S277G0Z USP skin protectant allantoin (5-ureidohydantoin) allantoin (5- 344S277G0Z USP corn/callus remover ureidohydantoin) allantoin (with a minobenzoin allantoin (with a 344S277G0Z sunscreen acid) minobenzoin acid) allantoin (wound healing claims allantoin (wound healing 344S277G0Z USP skin protectant only) claims only) Allithiamine Thiamine Hydrochloride? 67-03-8? USP if correct stuff Allopurinol Allopurinol Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 17th ed. Hudson, Ohio. Lexi-Comp, Inc. 2010: 66-67. Page 8 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances allyl isothiocyanate allyl isothiocyanate BN34FX42G3 cough/cold nasal decongestant allyl isothiocyanate allyl isothiocyanate BN34FX42G3 external analgesic counterirritant pending allyl isothiocyanate allyl isothiocyanate BN34FX42G3 external analgesic fever blister/cold sore almadrate sulfate almadrate sulfate 9104833TPA Not in USPNF, FCC or USPMC digestive aid antacid Almond Oil Almond Oil 8007-69-0 Oil USP aloe ingredients (aloe, aloe aloe ingredients (aloe, aloe V5VD430YW9, Not in USPNF, FCC or USPMC laxative stimulant laxative extract, aloe flower extract) extract, aloe flower extract) ZY8 Aloe Vera Aloe Vera Powder Not USP unless by another name aloe vera [see aloe} aloe vera [see aloe} 09TD8L5SQV Not in USPNF, FCC or USPMC gingivitis/plaque Aloe Vera Gel Extract Aloe Vera Gel Extract 85507-69-3 Gel Extract, Not USP unless by another 200:1 name aloes aloes V5VD430YW9 USP menstrual/diuretic aloin aloin W41H6S09F4 Not in USPNF, FCC or USPMC laxative stimulant laxative Page 9 of 1183 25 February 2014 IACP Nominations on Bulk Ingredients: FDA-2013-N-1524 Non USP Monographed and/or Non FDA Approved Drug Substances alpha Ketoglutaric acid alpha Ketoglutaric acid Not USP Alpha Tocopherol Alpha Tocopherol 10191-41-0 USP Alpha Tocopheryl Acetate Alpha Tocopheryl Acetate 7695-91-2 USP alum, ammonium alum, ammonium DPU64XYB1D USP oral health care astringent alum, ammonium alum, ammonium DPU64XYB1D USP skin protectant astringent alum, potassium alum, potassium 1L24V9R23S USP antifungal alum, potassium alum,