Durahist
Durahist
Approved
Approval ID
33d71863-5cac-669f-e063-6394a90a6f21
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Poly Pharmaceuticals, Inc.
DUNS: 198449894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexbrompheniramine Maleate, Pseudoephedrine HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50991-865
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dexbrompheniramine Maleate, Pseudoephedrine HCL
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (7)
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DEXBROMPHENIRAMINE MALEATEActive
Quantity: 2 mg in 1 1
Code: BPA9UT29BS
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT