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; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE | 0067-7918-06 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 0067-7919-12 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 0067-7923-02 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0067-8125-16 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 0067-8127-08 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 0067-8129-08 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN | 0067-8132-08 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; PHENIRAMINE MALEATE; ACETAMINOPHEN | 0067-8135-10 | Haleon US Holdings LLC | HUMAN OTC DRUG | Export only | |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0067-8136-10 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0067-8136-20 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE | 0067-8137-10 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE | 0067-8137-20 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CAFFEINE | 0067-8139-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CAFFEINE | 0067-8139-02 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 0067-8145-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE CITRATE; CAFFEINE; ACETAMINOPHEN; ASPIRIN | 0067-8147-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CAFFEINE; DIPHENHYDRAMINE CITRATE; ASPIRIN | 0067-8148-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CAFFEINE; ASPIRIN | 0067-8151-01 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE | 0067-8161-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0067-8200-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 0067-8201-03 | Haleon US Holdings LLC | NDA020802 | HUMAN OTC DRUG | NDA |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 0067-8202-03 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 0067-8203-02 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 0067-8203-03 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 0067-8203-04 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0067-8204-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 0067-8205-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 0067-8206-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0067-8211-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE | 0067-8212-01 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
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