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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 50090-6435-0  A-S Medication Solutions  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 0121-1550-40  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 68071-1350-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 60575-616-16  Respa Pharmaceuticals, Inc  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 0121-1550-10  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 68071-2472-4  NuCare Pharmaceuticals,Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 43378-105-08  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0273-1  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 68071-2935-4  NuCare Pharmaceuticals,Inc.  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 57963-103-04  The Generic Pharmaceutical Company  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 
CODEINE PHOSPHATE; GUAIFENESIN 53002-3191-1  RPK Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 21695-421-04  Rebel Distributors Corp.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-07  Akorn Operating Company LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 55154-5791-5  Cardinal Health 107, LLC  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 23359-040-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 0121-0775-16  PAI Holdings, LLC  M012  HUMAN OTC DRUG  OTC Monograph Drug 
GUAIFENESIN; CODEINE PHOSPHATE 54932-208-81  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 12634-969-04  Apotheca, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
CODEINE PHOSPHATE; GUAIFENESIN 68258-8904-4  Dispensing Solutions, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 70147-414-16  Glendale Inc  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; GUAIFENESIN 61919-110-04  DirectRX  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-16  The Generic Pharmaceutical Company  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 
GUAIFENESIN; CODEINE PHOSPHATE 69315-248-48  Leading 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 
CODEINE PHOSPHATE; GUAIFENESIN 70752-177-12  QUAGEN PHARMACEUTICALS LLC  part341  HUMAN OTC DRUG  OTC monograph final 
1-30 31-60 61-90 91-120 121-150 151-180 181-210 211-240 241-270 271-300
301-330 331-360 361-390 391-420 421-450 451-480 481-510 511-540 541-570 571-600
601-630 631-660 661-690 691-720 721-750 751-763

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