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; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 55758-043-08 | Pharmadel LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 55758-313-18 | Pharmadel LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
CAFFEINE; ACETAMINOPHEN; ASPIRIN | 55758-306-50 | Pharmadel LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 55758-314-18 | Pharmadel LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 55758-372-24 | Pharmadel LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; ACETAMINOPHEN; PYRILAMINE MALEATE | 55758-326-50 | Pharmadel LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 55758-381-18 | Pharmadel LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 55758-012-05 | Pharmadel LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 55758-026-04 | Pharmadel LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 55758-055-06 | Pharmadel LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ACETAMINOPHEN; PYRILAMINE MALEATE | 55758-326-25 | Pharmadel LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE | 55758-009-18 | Pharmadel LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 55758-311-06 | Pharmadel LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ACETAMINOPHEN; ASPIRIN | 55758-306-99 | Pharmadel LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE; DEXTROMETHORPHAN HYDROBROMIDE | 14505-398-06 | Pharmalab Enterprises, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 14505-399-06 | Pharmalab Enterprises, Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 54348-066-10 | PharmPak, Inc. | ANDA040736 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 54348-066-01 | PharmPak, Inc. | ANDA040736 | HUMAN PRESCRIPTION DRUG | ANDA |
CODEINE PHOSPHATE; ACETAMINOPHEN | 54348-015-01 | PharmPak, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN; PYRILAMINE MALEATE | 72090-026-02 | Pioneer Life Sciences, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE | 72090-006-25 | Pioneer Life Sciences, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ACETAMINOPHEN | 72090-004-02 | Pioneer Life Sciences, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 72090-008-30 | Pioneer Life Sciences, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 72090-007-02 | Pioneer Life Sciences, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 72090-005-01 | Pioneer Life Sciences, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 63548-0065-1 | PLD Acquisitions LLC D/B/A Avema Pharma Solutions | part343 | HUMAN OTC DRUG | OTC monograph not final |
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 72828-520-24 | Plus Distributors LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 50991-535-02 | Poly Pharmaceuticals, Inc. | HUMAN OTC DRUG | unapproved drug other | |
PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 50991-535-01 | Poly Pharmaceuticals, Inc. | HUMAN OTC DRUG | unapproved drug other | |
ASPIRIN; CAFFEINE; ACETAMINOPHEN | 52605-014-01 | Polygen Pharmaceuticals LLC | part343 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
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