Ibuprofen PM
Drug Facts
Approved
Approval ID
54c5b6dd-baac-40da-a2b6-e153d5a84a95
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Walgreens
DUNS: 008965063
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen, Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0363-0250
Application NumberANDA210676
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen, Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (15)
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT