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FDA Approval

DIPHENHYDRAMINE HYDROCHLORIDE

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

FDA Approval Summary

Company
Effective Date
April 8, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Diphenhydramine(50 mg in 1 1)

Products1

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

DIPHENHYDRAMINE HYDROCHLORIDE

Product Details

NDC Product Code
35916-0472
Application Number
M010
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
April 8, 2025
POLYETHYLENE GLYCOL 600Inactive
Code: NL4J9F21N9Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: TC2D6JAD40Class: ACTIBQuantity: 50 mg in 1 1
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