DICLOFENAC SODIUM
These highlights do not include all the information needed to use DICLOFENACSODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution, USP 2% w/w for topical use Initial U.S. Approval: 1988
Approved
Approval ID
e7304b3e-530a-4519-aed0-bed4512d8925
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DICLOFENAC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-033
Application NumberANDA217646
Product Classification
M
Marketing Category
C73584
G
Generic Name
DICLOFENAC
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 20 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROXYPROPYL CELLULOSE (430000 WAMW)Inactive
Code: VQ8ZWO78F6
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/16/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/16/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/16/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/16/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/16/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/16/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 4/16/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 4/16/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/16/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/16/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/16/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/16/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/16/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/16/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/16/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/16/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/16/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/16/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/16/2025