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 | 52959-002-24 | H.J. Harkins Company, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68210-5001-1 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 17856-0166-1 | ATLANTIC BIOLOGICALS CORP | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0363-9664-60 | WALGREENS CO. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68001-495-00 | BluePoint Laboratories | ANDA207229 | HUMAN OTC DRUG | ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 51013-191-14 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 58805-002-08 | Agile Pharmachem | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 72615-0001-0 | America's Pharmacy Source LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 37808-586-80 | H E B | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0135-0608-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 0113-0437-78 | L. Perrigo Company | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 51013-427-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE | 63029-656-16 | Medtech Products Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN | 56062-544-78 | Publix Super Markets Inc | ANDA075077 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN | 33992-0503-8 | GREENBRIER INTERNATIONAL, INC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 58602-730-67 | Aurohealth LLC | ANDA207229 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 58602-730-14 | Aurohealth LLC | ANDA207229 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 81238-3500-2 | Western First Aid Safety DBA Aramark | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 63868-809-08 | CHAIN DRUG MARKETING ASSOCIATION INC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0363-0175-15 | Walgreen Company | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 11822-1583-2 | Rite Aid Corporation | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 71335-1186-1 | Bryant Ranch Prepack | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 51672-2114-4 | Taro Pharmaceuticals U.S.A. Inc. | NDA018337 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 0536-1289-35 | Rugby Laboratories | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 47682-836-80 | Unifirst First Aid Corporation | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 53149-2002-6 | All Pharma LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 68016-135-00 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 50580-451-50 | Johnson & Johnson Consumer Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 69168-010-50 | Allegiant Health | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 50580-507-03 | Johnson & Johnson Consumer Inc. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
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