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; PYRILAMINE MALEATE; CAFFEINE | 67751-145-01 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PYRILAMINE MALEATE; CAFFEINE | 67751-145-02 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 67751-161-01 | Navajo Manufacturing Company Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 67751-167-01 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 67751-167-02 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 67751-167-03 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 67751-167-04 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; IBUPROFEN | 67751-211-01 | Navajo Manufacturing Company Inc. | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; IBUPROFEN | 67751-211-02 | Navajo Manufacturing Company Inc. | NDA211733 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 67751-215-01 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE | 67751-217-01 | Navajo Manufacturing Company Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE | 67751-217-02 | Navajo Manufacturing Company Inc. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 67877-322-01 | Ascend Laboratories, LLC | ANDA202076 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 67877-322-05 | Ascend Laboratories, LLC | ANDA202076 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 67877-322-10 | Ascend Laboratories, LLC | ANDA202076 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 68001-495-00 | BluePoint Laboratories | ANDA207229 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 68016-029-14 | Chain Drug Consortium, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68016-029-20 | Chain Drug Consortium, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68016-029-47 | Chain Drug Consortium, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 68016-103-04 | Chain Drug Consortium (Premier Value) | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 68016-135-00 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 68016-141-04 | Chain Drug Consortium (Premier Value) | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 68016-144-00 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 68016-144-01 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68016-146-00 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 68016-146-01 | Chain Drug Consortium, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 68016-147-16 | Pharmacy Value Alliance, LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 68016-148-16 | Pharmacy Value Alliance, LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 68016-160-02 | Chain Drug Consortium (Premier Value) | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 68016-173-24 | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e0ef968-dff3-4446-8412-8085677332f0 | part341 | HUMAN OTC DRUG | OTC monograph final |
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