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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DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 37012-480-20 | Shopko Stores Operating Co., LLC. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 37012-470-24 | Shopko Stores Operating Co., LLC. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 37012-480-24 | Shopko Stores Operating Co., LLC. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN | 70875-500-02 | Simpor Pharma Sdn Bhd | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 70875-500-04 | Simpor Pharma Sdn Bhd | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 70875-500-05 | Simpor Pharma Sdn Bhd | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 70875-500-03 | Simpor Pharma Sdn Bhd | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 70875-500-01 | Simpor Pharma Sdn Bhd | part343 | HUMAN OTC DRUG | OTC monograph not final |
ACETAMINOPHEN | 81389-001-01 | Sinew Pharma Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE | 59368-005-01 | Sixarp, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 49738-184-20 | SMART SENSE (Kmart) | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 49738-184-10 | SMART SENSE (Kmart) | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE | 49738-480-24 | SMART SENSE (Kmart) | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; ASPIRIN; CAFFEINE | 49738-184-50 | SMART SENSE (Kmart) | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN | 50405-009-24 | Sohm Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN | 50405-001-24 | SOHM Inc. | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE | 50405-006-24 | SOHM Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN; CAFFEINE; ASPIRIN | 50405-008-24 | SOHM Inc. | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE | 50405-003-24 | SOHM Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN | 50405-007-24 | SOHM Inc. | part343 | HUMAN OTC DRUG | OTC MONOGRAPH NOT FINAL |
CAFFEINE; BUTALBITAL; ACETAMINOPHEN | 43547-686-10 | SOLCO HEALTHCARE US, LLC | ANDA214087 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 55579-110-01 | Solupharm Pharmazeutische Erzeugnisse GmbH | ANDA202605 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 55579-405-24 | Solupharm Pharmazeutische Erzeugnisse GmbH | ANDA202605 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 69822-692-10 | Southern Sales & Service, Inc. | M013 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-23 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0406-0125-01 | SpecGx LLC | ANDA040400 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0406-0125-62 | SpecGx LLC | ANDA040400 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 0406-0376-01 | SpecGx LLC | ANDA206718 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 0406-0123-62 | SpecGx LLC | ANDA040409 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 0406-0522-01 | SpecGx LLC | ANDA040545 | HUMAN PRESCRIPTION DRUG | ANDA |
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