FDA Application
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NDC Search Results on Active Ingredient: acetaminophen
Click on Active Ingredient to view the label.
Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
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ACETAMINOPHEN | 47682-804-33 | Unifirst First Aid Corporation | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE | 52083-482-90 | Kramer Novis | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 52904-457-02 | Select Corporation | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 41163-512-02 | Supervalu Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 41250-335-40 | Meijer Distribution Inc | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE | 0363-9896-24 | Walgreens | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 50844-252-02 | L.N.K. International, Inc. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 53345-025-01 | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 73057-350-11 | Ulai Health LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 63824-241-10 | RB Health (US) LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 29485-7003-2 | Lil' Drug Store Products, Inc. | M013 | HUMAN OTC DRUG | OTC monograph final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 68737-235-19 | Eagle Distributors,Inc. | part338 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 41163-035-06 | EQUALINE (SuperValu) | part341 | HUMAN OTC DRUG | OTC monograph final |
POLYMYXIN B SULFATE; MAGNESIUM OXIDE; NEOMYCIN SULFATE; LIDOCAINE HYDROCHLORIDE; POTASSIUM CHLORIDE; CALCIUM CARBONATE; GUAIFENESIN; DIPHENHYDRAMINE HYDROCHLORIDE; MECLIZINE HYDROCHLORIDE; ACETAMINOPHEN; BENZALKONIUM CHLORIDE; LORATADINE; DEXTROMETHORPHAN HYDROBROMIDE; HYDROCORTISONE ACETATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE; BENZOCAINE; BACITRACIN ZINC; BISMUTH SUBSALICYLATE | 82652-021-01 | Remedy Pack LLC | ANDA076134 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 71309-077-04 | Safrel Pharmaceuticals, LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 41250-766-16 | Meijer Distribution Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 73097-013-50 | Savings Distributors LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 41520-064-76 | American Sales Company | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 60683-124-13 | Lab Safety Supply, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 59779-459-34 | CVS Pharmacy | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 59779-161-16 | CVS Pharmacy | part343 | HUMAN OTC DRUG | OTC monograph not final |
ASPIRIN; CAFFEINE; ACETAMINOPHEN | 73598-1372-1 | JHK Inc dba American Safety & First Aid | M013 | HUMAN OTC DRUG | OTC monograph drug |
ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE | 63029-656-06 | Medtech Products Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN | 24385-145-71 | Amerisource Bergen | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 36800-484-78 | Topco Associates LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 63868-234-12 | QUALITY CHOICE (Chain Drug Marketing Association) | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 82706-023-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 49580-0621-2 | P & L Development, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 36800-455-71 | Topco Associates LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 0904-5769-60 | Major Pharmaceuticals | ANDA075077 | HUMAN OTC DRUG | ANDA |
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