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Drugs A–Z

Diclofenac Sodium

Diclofenac Sodium is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.

Type
Over the counter (OTC)
Brand names
Arthritis Pain Relieving, Aspercreme Arthritis, kirkland signature arthritis pain relief
Taken
Topical
Label
Haleon US Holdings LLC, revised February 11, 2025 · full label on DailyMed

Purpose

Arthritis pain reliever

What it is used for

  • for the temporary relief of arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o foot, ankle, knee (lower body areas)
  • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Active ingredient

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

Do not use

  • if you have ever had an allergic reaction to any other pain reliever or to a fever reducer
  • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
  • right before or after heart surgery
  • on more than 2 body areas at the same time
  • in the eyes, nose or mouth

Ask a doctor before use if you have

if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water

Stop use and ask a doctor if

  • pain gets worse or lasts more than 21 days
  • redness or swelling is present in the painful area
  • fever occurs
  • skin irritation occurs
  • any new symptoms appear. These could be signs of a serious condition.
  • you experience any of the following signs of stomach bleeding: o feel faint o have bloody or black stools o vomit blood o have stomach pain that does not get better
  • you have symptoms of heart problems or stroke: o chest pain o trouble breathing o leg swelling o weakness in one part or side of body o slurred speech

Warnings

For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • asthma (wheezing)
  • skin reddening
  • blisters
  • facial swelling
  • shock
  • rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply
  • more or for a longer time than directed
  • when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use
  • if you have ever had an allergic reaction to any other pain reliever or to a fever reducer
  • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
  • right before or after heart surgery
  • on more than 2 body areas at the same time
  • in the eyes, nose or mouth Ask a doctor before use if
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if you are
  • under a doctor’s care for any serious condition
  • taking any other drug When using this product
  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if
  • pain gets worse or lasts more than 21 days
  • redness or swelling is present in the painful area
  • fever occurs
  • skin irritation occurs
  • any new symptoms appear. These could be signs of a serious condition.
  • you experience any of the following signs of stomach bleeding: o feel faint o have bloody or black stools o vomit blood o have stomach pain that does not get better
  • you have symptoms of heart problems or stroke: o chest pain o trouble breathing o leg swelling o weakness in one part or side of body o slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.

Diclofenac in the news

We have not covered this medicine yet. Latest news

Products being discontinued

Product Availability Expected supply / notes
Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-06)
Teva Pharmaceuticals USA, Inc.
A business decision was made to discontinue manufacture of the drug.
Being discontinued · August 13, 2026
Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-96)
Teva Pharmaceuticals USA, Inc.
A business decision was made to discontinue manufacture of the drug.
Being discontinued · August 13, 2026
Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-11)
Teva Pharmaceuticals USA, Inc.
A business decision was made to discontinue manufacture of the drug.
Being discontinued · August 13, 2026
Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-06)
Teva Pharmaceuticals USA, Inc.
A business decision was made to discontinue manufacture of the drug.
Being discontinued · August 13, 2026
Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-11)
Teva Pharmaceuticals USA, Inc.
A business decision was made to discontinue manufacture of the drug.
Being discontinued · August 13, 2026
Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-96)
Teva Pharmaceuticals USA, Inc.
A business decision was made to discontinue manufacture of the drug.
Being discontinued · August 13, 2026

All current drug shortages

Recalls

  • Class II Ongoing

    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

    Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

    SUN PHARMACEUTICAL INDUSTRIES INC

    Lots, distribution and details
    Lots / codes
    Lot # AD92721, Exp Date: 3/31/2027.
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    January 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0342-2026
  • Class III Ongoing

    Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

    Reason: Failed PH Specifications

    Cipla USA, Inc.

    Lots, distribution and details
    Product
    Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
    Lots / codes
    Batch XHBG; Exp. 08/31/2027
    Distribution
    Nationwide in the USA
    Quantity
    92,376 tubes
    Recall started
    December 22, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0291-2026
  • Class II Ongoing

    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…

    Reason: Defective Delivery System

    ALEMBIC PHARMACEUTICALS, INC.

    Lots, distribution and details
    Product
    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 Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
    Lots / codes
    Lot #: 220151, 220152, 220153, Exp. Date 11/2024
    Distribution
    Nationwide within the United States
    Quantity
    2844 units
    Recall started
    June 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0941-2023
  • Class II Ongoing

    Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

    Reason: Defective container: Out of specification for container integrity leading to bottles leaking.

    Preferred Pharmaceuticals, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: E1220B
    Distribution
    Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
    Quantity
    72 bottles
    Recall started
    November 29, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0278-2022

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

Get alerts for Diclofenac Sodium

We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.









Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 30a94282-0892-442a-aa10-6525cbd4fe88.


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Important: this content is for informational purposes only and is not medical advice, a prescribing instruction, or a recommendation to act. Consult a licensed healthcare professional before taking any medication.

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