Diclofenac Sodium
These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 2% w/w, for topical use Initial U.S. Approval: 1988
Approved
Approval ID
1757e3a8-6123-45f9-b5f8-46040bf07c6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-578
Application NumberNDA204623
Product Classification
M
Marketing Category
C73605
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 20 mg in 1 g
Code: QTG126297Q
Classification: ACTIB