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; PAMABROM; PYRILAMINE MALEATE | 50844-679-27 | L.N.K. International, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 50844-930-10 | L.N.K. International, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 50844-951-12 | L.N.K. International, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 50844-951-15 | L.N.K. International, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 50844-951-20 | L.N.K. International, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 50844-956-10 | L.N.K. International, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 50991-535-01 | Poly Pharmaceuticals, Inc. | HUMAN OTC DRUG | unapproved drug other | |
PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 50991-535-02 | Poly Pharmaceuticals, Inc. | HUMAN OTC DRUG | unapproved drug other | |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 51013-110-04 | PuraCap Pharmaceutical LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 51013-117-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 51013-118-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 51013-124-02 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 51013-128-25 | PuraCap Pharmaceutical LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 51013-130-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 51013-131-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 51013-134-01 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 51013-135-01 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 51013-141-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51013-143-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 51013-147-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE | 51013-154-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 51013-155-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 51013-156-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51013-157-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 51013-158-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51013-159-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51013-160-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 51013-162-08 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE | 51013-163-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 51013-164-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
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