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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DIPHENHYDRAMINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 79903-236-20 | WALMART INC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
IBUPROFEN; ACETAMINOPHEN | 79903-244-44 | WAL-MART STORES INC. | ANDA216592 | HUMAN OTC DRUG | ANDA |
CAFFEINE; ACETAMINOPHEN | 79903-373-01 | WAL-MART STORES INC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
IBUPROFEN; ACETAMINOPHEN | 79903-931-44 | Wal-Mart Stores Inc. | ANDA216592 | HUMAN OTC DRUG | ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 80070-330-04 | Foundation Consumer Brands | HUMAN OTC DRUG | UNAPPROVED DRUG OTHER | |
GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 80267-350-62 | Live Betr LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 80267-484-78 | Live Betr LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 80267-721-62 | Live Betr LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 80272-002-04 | Ellywell, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CAFFEINE; BUTALBITAL | 80425-0215-1 | Advanced Rx Pharmacy of Tennessee, LLC | ANDA213321 | HUMAN PRESCRIPTION DRUG | ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 80513-301-50 | Advanced Rx LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 80513-302-50 | Advanced Rx LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 80513-303-50 | Advanced Rx LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 80513-304-50 | Advanced Rx LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; BUTALBITAL | 81005-123-01 | Aarkish Pharmaceuticals NJ Inc. | ANDA214955 | HUMAN PRESCRIPTION DRUG | ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 81013-101-01 | Aspire Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE | 81013-102-01 | Aspire Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 81013-103-01 | Aspire Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; GUAIFENESIN | 81013-105-01 | Aspire Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 81033-002-05 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-10 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-20 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-30 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-31 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-40 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-41 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-50 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81033-002-51 | Kesin Pharma Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 81179-803-01 | YET HEALTH GROUP LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 81179-804-02 | YET HEALTH GROUP LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
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