Allergy Relief
Foster and Thrive 44-194
Approved
Approval ID
c9fa8d93-d9d6-4206-a13d-32b9e7555e7f
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Strategic Sourcing Services LLC
DUNS: 116956644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorpheniramine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70677-1016
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Chlorpheniramine maleate
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (6)
CHLORPHENIRAMINE MALEATEActive
Quantity: 4 mg in 1 1
Code: V1Q0O9OJ9Z
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT