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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GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 49580-0335-9 | P & L Development, LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE | 73097-009-02 | Savings Distributors LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PAMABROM; PYRILAMINE MALEATE; ACETAMINOPHEN | 71687-3102-4 | Focus Consumer Healthcare, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 58602-873-94 | Aurohealth LLC | ANDA207229 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN | 67046-025-60 | Coupler Enterprises Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN | 41226-628-16 | Kroger Company | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 69423-798-24 | The Procter & Gamble Manufacturing Company | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE | 55910-573-08 | DOLGENCORP, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 50844-664-08 | L.N.K. International, Inc. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 61245-175-13 | Conney Safety Products, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 0363-0484-71 | Walgreen Company | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ASPIRIN; CAFFEINE; ACETAMINOPHEN | 70005-004-02 | We Care Distributor Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 71335-9644-0 | Bryant Ranch Prepack | part343 | HUMAN OTC DRUG | OTC monograph not final |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51467-010-02 | FORTUNE PHARMACAL COMPANY LIMITED | M | 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; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 0363-2801-34 | Walgreen Company | part341 | HUMAN OTC DRUG | OTC monograph final |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 72854-133-66 | RB Health (US) LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 57243-560-02 | Salado Sales, Inc. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 71335-1398-1 | Bryant Ranch Prepack | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 68151-2262-4 | Carilion Materials Management | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 41250-317-78 | Meijer Distribution Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 0067-2039-84 | Haleon US Holdings LLC | NDA020802 | HUMAN OTC DRUG | NDA |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 69842-541-17 | CVS Pharmacy, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 72988-0027-1 | Lydia Co., Ltd. | HUMAN OTC DRUG | unapproved drug other | |
ACETAMINOPHEN | 50580-457-11 | Johnson & Johnson Consumer Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; IBUPROFEN | 58602-893-35 | Aurohealth LLC | ANDA218359 | HUMAN OTC DRUG | ANDA |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 53943-319-05 | DISCOUNT DRUG MART | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE | 64525-0556-6 | Quality Home Products | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 68998-300-03 | MARC GLASSMAN, INC. | ANDA211544 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; PHENIRAMINE MALEATE; ACETAMINOPHEN | 0067-8135-10 | Haleon US Holdings LLC | HUMAN OTC DRUG | Export only |
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