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FDA Approval

ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Cabinet Health P.B.C.
DUNS: 117102391
Effective Date
January 31, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Diphenhydramine(25 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl

Product Details

NDC Product Code
82725-1101
Application Number
M012
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
January 31, 2025
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DICALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: TC2D6JAD40Class: ACTIBQuantity: 25 mg in 1 1
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