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Aspercreme Arthritis
Diclofenac Sodium · Gel
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Diclofenac Sodium | .01 g/g | 855633 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Decreased Prostaglandin Production [PE] | PE | All 54 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 211253-001 | DICLOFENAC SODIUM | GEL | DICLOFENAC SODIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Manufacturing (CMC) | Approved | September 28, 2022 | Unknown |
| Supplement | 10 | Manufacturing (CMC) | Approved | October 23, 2020 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | October 23, 2020 | — |
| Supplement | 5 | Labeling | Approved | April 1, 2020 | Standard |
| Original application | 1 | Approved | May 16, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260112). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse s ■ for the temporary relief of arthritis pain ONLY in the following areas: ■ hand, wrist, elbow (upper body areas) ■ 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.
Purpose
openFDA Drug LabelingPurpose Arthritis pain reliever *nonsteroidal anti-inflammatory drug
Dosage and Administration
openFDA Drug LabelingDirections Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain : ■ Use 4 times per day every day ■ Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose ■ For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) ■ For each lower body area (foot, ankle or knee) – Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: ■ use only as directed ■ do not use more than directed or for longer than directed ■ apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes ■ do not apply in same area as any other product ■ do not apply with external heat such as heating pad ■ do not apply a bandage over the treated area ■ store ENCLOSED DOSING CARD with your Aspercreme Arthritis Pain. The dosing card is re-usable. Other information ■ store at 20-25°C (68-77°F). Keep from freezing. ■ read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.
Warnings
openFDA Drug LabelingWarnings 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: ■ feel faint ■ have bloody or black stools ■ vomit blood ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ leg swelling ■ weakness in one part or side of body ■ slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product during the last 3 months of 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 (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo 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
openFDA Drug LabelingAsk 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.
Stop Use
openFDA Drug LabelingStop 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: ■ feel faint ■ have bloody or black stools ■ vomit blood ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ leg swelling ■ weakness in one part or side of body ■ slurred speech
Active Ingredient
openFDA Drug LabelingActive ingredient Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DICLOFENAC SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 41167-0571-0 | 41167-0571 | Chattem, Inc. | 1 TUBE in 1 CARTON (41167-0571-0) / 50 g in 1 TUBE | February 1, 2024 |
| 41167-0571-1 | 41167-0571 | Chattem, Inc. | 1 TUBE in 1 CARTON (41167-0571-1) / 100 g in 1 TUBE | February 1, 2024 |
| 41167-0573-2 | 41167-0573 | Chattem, Inc. | 1 TUBE in 1 CARTON (41167-0573-2) / 50 g in 1 TUBE | April 15, 2021 |
| 41167-0573-3 | 41167-0573 | Chattem, Inc. | 1 TUBE in 1 CARTON (41167-0573-3) / 100 g in 1 TUBE | April 15, 2021 |
| 41167-0571 | 41167-0571 | Chattem, Inc. | — | February 1, 2024 |
| 41167-0573 | 41167-0573 | Chattem, Inc. | — | April 15, 2021 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.