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; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 29485-8057-3 | Lil' Drug Store Products, Inc. | M012 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 0904-1987-80 | Major Pharmaceuticals | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 75712-010-40 | DOLGENCORP, INC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 72162-2279-2 | Bryant Ranch Prepack | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; IBUPROFEN | 76162-501-16 | Topco Associates LLC | ANDA214836 | HUMAN OTC DRUG | ANDA |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 79903-155-42 | WALMART INC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 0031-0100-04 | Haleon US Holdings LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 11673-519-20 | Target Corporation | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; TRIPROLIDINE HYDROCHLORIDE | 69842-966-06 | CVS PHARMACY, INC | part341 | HUMAN OTC DRUG | OTC monograph final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 36800-964-91 | Topco Associates LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
PYRILAMINE MALEATE; CAFFEINE; ACETAMINOPHEN | 24689-121-01 | APNAR PHARMA LP | part343 | HUMAN OTC DRUG | OTC monograph not final |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 0067-2039-94 | Haleon US Holdings LLC | NDA020802 | HUMAN OTC DRUG | NDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 49035-558-42 | Wal-Mart Stores Inc | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 82501-1579-1 | Gobrands, Inc | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 50580-170-01 | Johnson & Johnson Consumer Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 69842-168-47 | CVS Pharmacy | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 11822-0812-6 | Rite Aid Corporation | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 41250-227-78 | Meijer Distribution Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE | 69729-131-50 | OPMX LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 51316-695-04 | CVS PHARMACY | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
GUAIFENESIN; CHLORPHENIRAMINE MALEATE; CAFFEINE; PENTOXYVERINE CITRATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51352-189-73 | DONGWHA PHARM. CO. LTD. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PYRILAMINE MALEATE; CAFFEINE | 67751-145-01 | Navajo Manufacturing Company Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 72854-138-66 | RB Health (US) LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 68210-4087-1 | SPIRIT PHARMACEUTICALS LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0363-0792-40 | WALGREEN CO. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 47682-509-03 | Unifirst First Aid Corporation | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN | 72854-126-08 | RB Health (US) LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 72288-437-78 | Amazon.com Services LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 63824-954-04 | RB Health (US) LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 0113-4500-62 | L. Perrigo Company | part341 | HUMAN OTC DRUG | OTC monograph final |
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