DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride Capsules USP 50 mg (Dye-free)
Approved
Approval ID
32033991-a4f0-f767-e063-6394a90a0b06
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Softgel Healthcare Pvt Ltd
DUNS: 675584180
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 Code35916-0472
Application NumberM010
Product Classification
M
Marketing Category
C200263
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (8)
POLYETHYLENE GLYCOL 600Inactive
Code: NL4J9F21N9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB