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 | 41520-982-25 | FOODHOLD U.S.A., LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 41520-956-31 | FOODHOLD U.S.A., LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 41520-984-14 | FOODHOLD U.S.A., LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 41520-919-20 | FOODHOLD U.S.A., LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 41520-919-12 | FOODHOLD U.S.A., LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 72245-683-03 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 72245-682-03 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 72245-193-03 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 72245-681-03 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 72245-683-10 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 72245-648-50 | Forte Bio-Pharma LLC | ANDA202142 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 72245-648-12 | Forte Bio-Pharma LLC | ANDA202142 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 72245-681-10 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 72245-193-10 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 72245-682-10 | Forte Bio-Pharma LLC | ANDA040608 | HUMAN PRESCRIPTION DRUG | ANDA |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 51467-005-01 | FORTUNE PHARMACAL COMPANY LIMITED | M | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51467-008-01 | FORTUNE PHARMACAL COMPANY LIMITED | part341 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51467-010-02 | FORTUNE PHARMACAL COMPANY LIMITED | M | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 51467-006-01 | FORTUNE PHARMACAL COMPANY LIMITED | part341 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51467-010-01 | FORTUNE PHARMACAL COMPANY LIMITED | M | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 51467-007-01 | FORTUNE PHARMACAL COMPANY LIMITED | M | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 51467-007-02 | FORTUNE PHARMACAL COMPANY LIMITED | M | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51467-008-02 | FORTUNE PHARMACAL COMPANY LIMITED | part341 | HUMAN OTC DRUG | OTC monograph final |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 51467-005-02 | FORTUNE PHARMACAL COMPANY LIMITED | M | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 51467-127-24 | FORTUNE PHARMACAL COMPANY, LIMITED | part343 | HUMAN OTC DRUG | OTC monograph not final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 80070-330-04 | Foundation Consumer Brands | HUMAN OTC DRUG | UNAPPROVED DRUG OTHER | |
ACETAMINOPHEN; CAFFEINE | 69293-565-16 | Four Ventures Enterprises, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 55315-060-50 | Freds Inc | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 55315-082-04 | Freds Inc | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 55315-443-12 | Freds Inc | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
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