MedPath

All Night Pain Relief PM

Drug Facts

Approved
Approval ID

12ab219a-051c-4e54-98e1-32cb3689586e

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.

Naproxen Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0844
Application NumberANDA209726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (11)

DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 220 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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All Night Pain Relief PM - FDA Drug Approval Details