MedPath

PENNSAID

These highlights do not include all the information needed to use PENNSAID safely and effectively. See full prescribing information for PENNSAID. PENNSAID (diclofenac sodium topical solution) 1.5% w/w is for topical use only. Initial U.S. Approval: 1988

Approved
Approval ID

4732a181-9fe0-49b4-b486-e2da9ad66e31

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 1, 2010

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

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 Code16590-453
Application NumberNDA020947
Product Classification
M
Marketing Category
C73594
G
Generic Name
DICLOFENAC SODIUM
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 1, 2010
FDA Product Classification

INGREDIENTS (6)

DICLOFENAC SODIUMActive
Quantity: 16.05 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 1/20/2010

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

****See full prescribing information for complete boxed warning.

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/20/2010

1. INDICATIONS AND USAGE

PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

Key Highlight

PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1)

DOSAGE FORMS & STRENGTHS SECTION

LOINC: 43678-2Updated: 1/20/2010

3. DOSAGE FORMS AND STRENGTHS

1.5% w/w topical solution

Key Highlight
  • 1.5% w/w topical solution (3)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

PENNSAID - FDA Drug Approval Details