FDA Application
-
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 |
---|---|---|---|---|---|
ACETAMINOPHEN | 25000-071-11 | MARKSANS PHARMA LIMITED | ANDA215486 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 51316-627-09 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 48433-401-25 | Safecor Health, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 11673-437-78 | Target Corporation | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 51013-159-04 | PuraCap Pharmaceutical LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 83059-0030-1 | Shield Pharmaceuticals Corp | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CAFFEINE; ASPIRIN | 0067-2042-05 | Haleon US Holdings LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 55910-599-48 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 63941-192-02 | VALU MERCHANDISERS COMPANY | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
CAFFEINE; ACETAMINOPHEN; METHYLEPHEDRINE HYDROCHLORIDE, (+/-)-; GUAIFENESIN; CHLORPHENIRAMINE | 55277-1001-1 | Kafus Co., Ltd | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 55319-926-12 | FAMILY DOLLAR SERVICES INC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 49035-777-08 | Wal-Mart Stores Inc | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN | 75712-007-20 | DOLGENCORP, INC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE | 56062-459-40 | Publix Super Markets Inc | part341 | HUMAN OTC DRUG | OTC monograph final |
PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 63824-237-21 | RB Health (US) LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN | 33261-142-20 | Aidarex Pharmaceuticals LLC | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN | 79903-032-10 | Wal-Mart Stores Inc | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN | 10267-2634-7 | Contract Pharmacal Corp. | HUMAN OTC DRUG | Export only | |
ACETAMINOPHEN | 49483-341-10 | TIME CAP LABS INC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0113-0518-83 | L. Perrigo Company | part343 | HUMAN OTC DRUG | OTC monograph not final |
ASPIRIN; ACETAMINOPHEN; CAFFEINE | 0067-2039-92 | Haleon US Holdings LLC | NDA020802 | HUMAN OTC DRUG | NDA |
PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE | 29485-7964-2 | Lil' Drug Store Products, Inc. | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 55910-506-78 | Dolgencorp, LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN; IBUPROFEN | 50580-208-16 | Johnson & Johnson Consumer Inc. | ANDA214836 | HUMAN OTC DRUG | ANDA |
CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 55910-031-04 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 11822-0959-1 | Rite Aid Corporation | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 59726-494-24 | P & L Development, LLC | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN | 0113-0484-71 | L. Perrigo Company | part343 | HUMAN OTC DRUG | OTC monograph not final |
CAFFEINE; ASPIRIN; ACETAMINOPHEN | 81522-374-62 | FSA Store Inc. | ANDA075794 | HUMAN OTC DRUG | ANDA |
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 79481-0030-4 | Meijer, Inc. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
-