FDA label

What is diclofenac used for?

The FDA-approved uses of diclofenac, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).”

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Diclofenac Sodium, tablet, delayed release

Indications and Usage, quoted from the label by Umedica Laboratories USA Inc. (ANDA219945). Cross-references to other label sections are left out.

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).

Diclofenac sodium delayed-release tablets are indicated:

  • For relief of the signs and symptoms of osteoarthritis
  • For relief of the signs and symptoms of rheumatoid arthritis
  • For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Source: DailyMed label, set id 0e5c6669-390f-4c32-b9b8-13ed3c517462, version 6, effective January 30, 2026. NDC 60290-082, one of 120 listings for this product.

Diclofenac Sodium, solution

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA203818). Cross-references to other label sections are left out.

Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

Source: DailyMed label, set id b60e6572-0624-40c5-e053-2995a90ade48, version 4, effective July 24, 2026. NDC 51672-1358, one of 66 listings for this product.

Diclofenac Sodium Topical, gel

Indications and Usage, quoted from the label by Alembic Pharmaceuticals Limited (ANDA212351). Cross-references to other label sections are left out.

Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK).

Source: DailyMed label, set id 11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd, version 1, effective March 4, 2025. NDC 46708-581, one of 49 listings for this product.

Questions

What is diclofenac used for?

The FDA label says: “Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).”

What drug class is diclofenac?

FDA lists diclofenac in the Nonsteroidal Anti-inflammatory Drug established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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