Quick answers
- What is Diclofenac used for?
- The FDA-approved label (Zipsor, Assertio Specialty Pharmaceuticals LLC, March 1, 2026) says: “ZIPSOR is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ZIPSOR is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Diclofenac have a boxed warning?
- Yes. The FDA label for Zipsor has a boxed warning (“WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Diclofenac?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated August 13, 2026). Ask your pharmacist about alternatives.
- Has Diclofenac been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started January 27, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Diclofenac?
- 82 companies list prescription products of Diclofenac in the FDA NDC Directory, including A-S Medication Solutions, Proficient Rx LP and Bryant Ranch Prepack.
What Diclofenac is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZIPSOR is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ZIPSOR is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.
— FDA label: Zipsor, Assertio Specialty Pharmaceuticals LLC, effective March 1, 2026. Read the full label on DailyMed →
The FDA has 286 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
. Read it on the full label →
275 of 286 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, delayed release · Solution · Gel · Tablet, film coated · Capsule, liquid filled · Tablet, coated · Powder, for solution · Tablet · Tablet, film coated, extended release · Solution/ drops |
|---|---|
| Route | Oral · Topical · Ophthalmic · Transdermal |
| Prescription products | 331 in the FDA NDC Directory |
| Brand names | Zipsor, Lofena, Cambia |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| diclofenac potassium 25 mg capsule, liquid filled | Generic | $2.96 per capsule |
| diclofenac potassium 25 mg tablet | Generic | $4.10 per tablet |
| diclofenac potassium 25 mg tablet, coated | Generic | $4.10 per tablet |
| diclofenac potassium 25 mg tablet, film coated | Generic | $4.10 per tablet |
| diclofenac potassium 50 mg powder, for solution | Generic | $11.52 per unit |
| diclofenac potassium 50 mg tablet | Generic | $0.1213 per tablet |
| diclofenac potassium 50 mg tablet, coated | Generic | $0.1213 per tablet |
| diclofenac potassium 50 mg tablet, film coated | Generic | $0.1213 per tablet |
| diclofenac sodium 1 mg/mL solution | Generic | $1.60–$1.71 per mL 4 packages, lowest to highest |
| diclofenac sodium 1 mg/mL solution/ drops | Generic | $1.71 per mL |
| diclofenac sodium 100 mg tablet, extended release | Generic | $0.6355 per tablet |
| diclofenac sodium 100 mg tablet, film coated | Generic | $0.6355 per tablet |
| diclofenac sodium 16.05 mg/mL solution | Generic | $0.1252 per mL |
| diclofenac sodium 2% solution | Generic | $0.3865 per gram |
| diclofenac sodium 25 mg tablet, delayed release | Generic | $0.6626 per tablet |
| diclofenac sodium 3% gel | Generic | $0.3526 per gram |
| diclofenac sodium 50 mg tablet, delayed release | Generic | $0.0630 per tablet |
| diclofenac sodium 75 mg tablet, delayed release | Generic | $0.0630 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions29 products
- Proficient Rx LP27 products
- Bryant Ranch Prepack25 products
- Preferred Pharmaceuticals Inc.18 products
- NuCare Pharmaceuticals, Inc.17 products
- Asclemed USA, Inc.15 products
- Remedyrepack Inc.12 products
- Advanced Rx of Tennessee, LLC12 products
- Advanced Rx Pharmacy of Tennessee, LLC11 products
- Phoenix RX LLC11 products
- Direct_Rx10 products
- Golden State Medical Supply, Inc.9 products
- Advagen Pharma Ltd7 products
- Umedica Laboratories USA Inc.6 products
- Northwind Health Company, LLC5 products
- Carlsbad Technology, Inc.5 products
- AvKARE4 products
- PD-Rx Pharmaceuticals, Inc.4 products
- Aurobindo Pharma Limited4 products
- NorthStar Rx LLC4 products
- BluePoint Laboratories4 products
- SOLA Pharmaceuticals, LLC4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Rising Pharma Holdings, Inc.3 products
- Actavis Pharma, Inc.3 products
- Redpharm Drug3 products
- Quality Care Products, LLC3 products
- Amici Pharma, Inc.3 products
- DirectRx2 products
- Ingenus Pharmaceuticals, LLC2 products
- Amneal Pharmaceuticals LLC2 products
- American Health Packaging2 products
- Alembic Pharmaceuticals Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Sportpharm LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Coupler LLC2 products
- Nivagen Pharmaceuticals, Inc.2 products
- Leading Pharma, LLC2 products
- Carwin Pharmaceutical Associates, LLC2 products
- INA Pharmaceutics Inc2 products
- Assertio Therapeutics, Inc.2 products
- Hawaii Repack, Inc.1 product
- Encube Ethicals, Inc.1 product
- Edenbridge Pharmaceuticals LLC.1 product
- Altaire Pharmaceuticals Inc.1 product
- RedPharm Drug, Inc.1 product
- Aurolife Pharma, LLC1 product
- Sandoz Inc1 product
- NuCare Pharmaceuticals, LLC.1 product
- Bausch & Lomb Incorporated1 product
- Padagis Israel Pharmaceuticals Ltd1 product
- Novel Laboratories, Inc.1 product
- Medsource Pharmaceuticals1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Oceanside Pharmaceuticals1 product
- SOLA Pharmaceuticals1 product
- Apotex Corp.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Ascend Laboratories, LLC1 product
- Doc Rx1 product
- Lifsa Drugs LLC1 product
- Archis Pharma LLC1 product
- Puretek Corporation1 product
- Strides Pharma Science Limited1 product
- Par Health USA, LLC1 product
- Torrent Pharmaceuticals Limited1 product
- Chartwell RX, LLC1 product
- Havix Group Inc d-b-a Aavis Pharmaceuticals1 product
- Assertio Specialty Pharmaceuticals LLC1 product
- VICI Pharmaceuticals, Inc1 product
- Marlex Pharmaceuticals, Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Cintex Services, LLC1 product
- Trifluent Pharma, LLC1 product
- Amerisyn LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Teva Pharmaceuticals, Inc.1 product
- Happy Robin, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022122 VOLTAREN ARTHRITIS PAIN | Haleon Us Holdings | October 17, 2007 | 16, latest August 7, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
| NDA022165 CAMBIA | Cosette | June 17, 2009 | 9, latest November 21, 2024 2024: Labeling · 2024: Labeling · 2021: Labeling |
| NDA022202 ZIPSOR | Cosette | June 16, 2009 | 8, latest November 21, 2024 2024: Labeling · 2021: Labeling · 2021: Efficacy |
Generic approvals (51)
- ANDA074514Actavis Elizabeth · March 26, 1996
- ANDA075219Teva · August 6, 1998
- ANDA075185Carlsbad · November 13, 1998
- ANDA075229Rubicon Research · November 20, 1998
- ANDA075463Rising · July 26, 1999
- ANDA075492Vpna · February 11, 2000
- ANDA076152Aurobindo Pharma USA · December 13, 2001
- ANDA075281Aurobindo Pharma USA · February 12, 2002
- ANDA076201Dexcel Ltd · November 6, 2002
- ANDA076561Pangea · March 18, 2004
- ANDA077863Unique · June 8, 2007
- ANDA078792Bausch and Lomb · December 28, 2007
- ANDA078031Sandoz · February 6, 2008
- ANDA077600Rubicon Research · November 13, 2008
- ANDA090066Unique · December 1, 2010
- ANDA200936Amneal · October 28, 2013
- ANDA203818Sun Pharma Canada · November 26, 2014
- ANDA202769Pai Holdings Pharm · July 8, 2015
- ANDA204132Lupin · August 20, 2015
- ANDA203383Altaire Pharms Inc · November 16, 2015
- ANDA206493Actavis Mid Atlantic · December 2, 2015
- ANDA205878Novel Labs Inc · December 9, 2015
- ANDA204648Bionpharma · February 23, 2016
- ANDA206298Sun Pharma Canada · April 28, 2016
- ANDA202964Ph Health · May 2, 2016
- ANDA206116Amneal Pharms · September 2, 2016
- ANDA208301Glenmark Pharms Ltd · September 13, 2016
- ANDA210893Padagis Israel · July 27, 2018
- ANDA209903Cipla · August 3, 2018
- ANDA210078Onesource · December 3, 2019
- ANDA210986Encube · January 27, 2020
- ANDA215585Ingenus Pharms LLC · October 8, 2021
- ANDA213875Aurobindo Pharma Ltd · October 19, 2021
- ANDA215375Annora Pharma · March 4, 2022
- ANDA207714Apotex · May 6, 2022
- ANDA215750Umedica · May 11, 2022
- ANDA216635Alkem Labs Ltd · July 20, 2022
- ANDA212351Alembic · July 27, 2022
- ANDA208198Amneal · August 18, 2022
- ANDA208021Lupin Pharms · September 21, 2022
Showing the 40 earliest of 51.
Shortage status
To be discontinued · updated August 13, 2026 · first posted August 13, 2026
| Product | Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-06) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 27, 2026 · Class II · Ongoing · D-0342-2026
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 — SUN PHARMACEUTICAL INDUSTRIES INC
-
June 22, 2023 · Class II · Ongoing · D-0941-2023
Defective Delivery System
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Di — ALEMBIC PHARMACEUTICALS, INC.
-
July 2, 2019 · Class II · Completed · D-0461-2020
Lack of Assurance of Sterility
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05 — Altaire Pharmaceuticals, Inc.
-
July 2, 2019 · Class II · Completed · D-0421-2020
Lack of Assurance of Sterility
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02 — Altaire Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zipsor, Assertio Specialty Pharmaceuticals LLC, effective March 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →