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 | 82706-012-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 82706-015-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 82706-015-02 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 82706-016-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 82706-016-02 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 82706-017-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 82706-018-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 82706-020-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 82706-020-02 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 82706-022-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 82706-023-01 | VIVUNT PHARMA LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 82804-002-30 | Proficient Rx LP | ANDA075794 | HUMAN OTC DRUG | ANDA |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 82804-002-60 | Proficient Rx LP | ANDA075794 | HUMAN OTC DRUG | ANDA |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 82804-002-90 | Proficient Rx LP | ANDA075794 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 82804-003-30 | Proficient Rx LP | ANDA040400 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 82804-003-60 | Proficient Rx LP | ANDA040400 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 82804-003-90 | Proficient Rx LP | ANDA040400 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 82804-008-30 | Proficient Rx LP | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 82804-008-60 | Proficient Rx LP | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 82804-008-90 | Proficient Rx LP | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 83008-002-30 | Quality Care Products, LLC | ANDA040405 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 83008-002-60 | Quality Care Products, LLC | ANDA040405 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 83008-002-90 | Quality Care Products, LLC | ANDA040405 | HUMAN PRESCRIPTION DRUG | ANDA |
CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN | 83049-489-08 | O Positiv, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 83057-0001-6 | HBC Pharma, LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 83057-0003-6 | HBC Pharma, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE | 83059-0006-1 | Shield Pharmaceuticals Corp | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 83059-0023-1 | Shield Pharmaceuticals Corp | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 83059-0024-1 | Shield Pharmaceuticals Corp | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN | 83059-0029-1 | Shield Pharmaceuticals Corp | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
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