DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride Oral Solution USP
Approved
Approval ID
6fe6fe2d-4405-4e7a-a2ed-5eb367d52842
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2022
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
Products 2
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 Code0121-0978
Application NumberANDA087513
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2022
FDA Product Classification
INGREDIENTS (8)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 10 mL
Code: TC2D6JAD40
Classification: ACTIB
DIPHENHYDRAMINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0489
Application NumberANDA087513
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2022
FDA Product Classification
INGREDIENTS (8)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 5 mL
Code: TC2D6JAD40
Classification: ACTIB