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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PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE | 63824-959-64 | RB Health (US) LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN | 76281-525-24 | AptaPharma Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 57344-170-12 | AAA Pharmaceutical, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 50580-449-14 | Johnson & Johnson Consumer Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 50580-449-09 | Johnson & Johnson Consumer Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 63868-084-10 | Chain Drug Marketing Association | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 37000-517-08 | The Procter & Gamble Manufacturing Company | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 55910-982-08 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 59726-399-24 | P & L Development, LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 63868-578-24 | CHAIN DRUG MARKETING ASSOCIATION INC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 50436-6719-1 | Unit Dose Services | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 0067-2035-50 | Haleon US Holdings LLC | NDA020802 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN | 55910-010-26 | Dolgencorp Inc | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 68998-139-02 | Marc Glassman, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 41250-374-82 | Meijer Distribution Inc | ANDA075794 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 69256-966-83 | Harris Teeter, LLC | ANDA075077 | HUMAN OTC DRUG | ANDA |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 47682-543-03 | Unifirst First Aid Corporation | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 68016-144-00 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 72288-959-26 | Amazon.com Services LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 71309-006-30 | Safrel Pharmaceuticals, LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 37808-708-26 | H E B | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 25000-071-45 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 50332-0129-7 | HART Health | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 51013-155-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 66715-6332-3 | Lil' Drug Store Products, Inc. | M012 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 55910-459-40 | Dolgencorp, LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; IBUPROFEN | 58602-895-21 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 49314-1763-3 | Unishield | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 51013-198-14 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 0363-2029-40 | Walgreen Company | part341 | HUMAN OTC DRUG | OTC monograph final |
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