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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DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 0280-0922-06 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN | 0280-0924-12 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 0280-1138-20 | Bayer HealthCare LLC. | part343 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0280-1580-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 0280-1581-40 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 0280-1590-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0280-1600-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0280-1610-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE | 0280-1620-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 0280-1630-16 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 0280-1630-24 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0280-1640-16 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0280-1640-24 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0280-1650-16 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0280-1680-24 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 0280-8005-01 | Bayer HealthCare LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 0280-8005-02 | Bayer HealthCare LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 0280-8005-16 | Bayer HealthCare LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 0280-8005-24 | Bayer HealthCare LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 0280-8005-40 | Bayer HealthCare LLC. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE | 0280-8015-24 | Bayer HealthCare LLC | M027 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0280-8090-20 | Bayer HealthCare LLC. | ANDA075077 | HUMAN OTC DRUG | ANDA |
ASPIRIN; CAFFEINE; ACETAMINOPHEN | 0363-0021-80 | Walgreens | part343 | HUMAN OTC DRUG | OTC monograph not final |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 0363-0034-04 | Walgreens | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN | 0363-0109-24 | Walgreens | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 0363-0132-01 | Walgreens | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0363-0132-02 | Walgreens | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0363-0143-03 | Walgreens Co. | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN | 0363-0143-06 | Walgreens Co. | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN | 0363-0161-10 | Walgreen Company | part343 | HUMAN OTC DRUG | OTC monograph not final |
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