Childrens Chewable Allergy Relief
Kroger Diphenhydramine Hydrochloride 12.5 mg Chewable Tablets - Childrens Grape Flavor
Approved
Approval ID
2cac72be-4830-ad49-e063-6394a90a7832
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 16, 2025
Manufacturers
FDA
KROGER COMPANY
DUNS: 006999528
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code41226-669
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (14)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
D&C RED NO. 30 ALUMINUM LAKEInactive
Code: GE75M6YV5W
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYDROXYPROPYLCELLULOSEInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT