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U.S. Department of Health and Human Services

FDA Application
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NDC Search Results on Active Ingredient: codeine

Click on Active Ingredient to view the label.

Ingredient Name NDC Company Name Application Number or Regulatory Citation Product Type Marketing Category
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-12  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 58657-500-16  Method Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
PSEUDOEPHEDRINE; CODEINE PHOSPHATE; GUAIFENESIN 43378-126-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN; CODEINE PHOSPHATE 43378-124-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN 43378-121-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 70752-180-12  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0208-1  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1775-00  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 53002-3191-1  RPK Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 66594-499-16  Pro-Pharma, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 0121-0775-04  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; PYRILAMINE MALEATE 66594-333-16  Pro-Pharma LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 23359-023-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 70752-177-06  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 55154-5791-5  Cardinal Health 107, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 60575-414-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; PYRILAMINE MALEATE 66594-333-01  Pro-Pharma LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 70861-1107-1  Bishop Pharma, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 68071-5173-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN 70147-414-16  Glendale Inc  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 57963-103-16  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0273-2  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 0121-0775-08  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 43378-106-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 70752-180-06  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 55154-9627-5  Cardinal Health 107, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0500-5  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 43378-120-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 69367-272-16  Westminster Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC MONOGRAPH DRUG 
CODEINE PHOSPHATE; GUAIFENESIN 50436-2520-1  Unit Dose Services  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 50090-0423-0  A-S Medication Solutions  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 72162-1669-2  Bryant Ranch Prepack  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 54932-208-81  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 60575-313-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 60575-616-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 71205-624-04  Proficient Rx LP  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 29978-420-16  Capital Pharmaceutical, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 57963-103-04  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-16  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 58605-303-16  MCR American Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-05  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 69315-248-48  Leading Pharma, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 70752-180-15  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-10  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 58657-500-04  Method Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 68788-8361-1  Preferred Pharmaceuticals Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 58605-313-16  MCR American Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 70752-177-15  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1775-10  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1775-05  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 21695-421-04  Rebel Distributors Corp.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 68258-8904-4  Dispensing Solutions, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 63187-117-04  Proficient Rx LP  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 69367-272-04  Westminster Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC MONOGRAPH DRUG 
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 43378-125-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 71205-363-04  Proficient Rx LP  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 70156-112-04  Noble Pharmaceuticals, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 0682-0475-16  Marnel Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 50991-723-16  Poly Pharmaceuticals, Inc.    HUMAN OTC DRUG  unapproved drug other 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 54859-520-16  Llorens Pharmaceutical International Division  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50090-5398-0  A-S Medication Solutions  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 54932-208-86  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 60575-515-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1550-40  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 43378-104-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 68071-1350-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 60575-212-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 58605-303-10  MCR American Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN 43378-123-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 69315-248-12  Leading Pharma, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1550-10  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 68071-2935-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0273-1  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 29978-420-15  Capital Pharmaceutical, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 68071-2472-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50090-6435-0  A-S Medication Solutions  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 43378-105-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 54932-208-85  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1550-00  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-07  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 50090-1428-0  A-S Medication Solutions  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-04  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 70147-313-16  Glendale Inc  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 61919-110-04  DirectRX  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 23359-040-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 12634-969-04  Apotheca, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 50991-723-15  Poly Pharmaceuticals, Inc.    HUMAN OTC DRUG  unapproved drug other 
CODEINE PHOSPHATE; GUAIFENESIN 0121-0775-16  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
CODEINE PHOSPHATE; GUAIFENESIN 70752-177-12  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 66594-499-01  Pro-Pharma, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1775-40  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
ACETAMINOPHEN; CODEINE PHOSPHATE 68788-7835-3  Preferred Pharmaceuticals Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 45865-439-30  Medsource Pharmaceuticals  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 13107-060-99  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-20  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50383-338-10  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-15  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 0121-0504-16  PAI Holdings, LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 71930-054-52  Eywa Pharma Inc  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4430-8  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
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