Aleve Arthritis Pain Gel

Manufacturer
Bayer HealthCare LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:02

Label at a glance#

ProductAleve Arthritis Pain Gel
Active ingredientDICLOFENAC SODIUM
Label structure10 sections

Indications and uses

for 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.

Dosage and administration

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 g...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Arthritis pain reliever

Uses

INDICATIONS & USAGE SECTION

  • for 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.

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is 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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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 18 years.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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.

DailyPer 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 (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 for longer than directed
  • apply to only clean, dry skin that does not have cuts, open wounds, infections or rashes
  • do not apply in the same area as any other product
  • do not apply with external heat such as heating pad
  • do not apply to bandage over the treated area
  • store ENCLOSED DOSING CARD with your ALEVE Arthritis Pain. The dosing cards is re-usable.

Other information

OTHER SAFETY 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

CARBOMER HOMOPOLYER TYPE C, COCOYL CAPRYLOCAPRATE, FRAGRANCE, ISOPROPYL ALCOHOL; MINERAL OIL; POLYOXYL 20 CETOSTEARYL ETHER; PROPYLENE GLYCOL, PURIFIED WATER, STRONG AMONIA SOLUTION

OTC - QUESTIONS SECTION

Questions or Comments 1-800-395-0689

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

DIFFERENT

INGREDIENT

DICLOFENAC

SODIUM

ALEVE® ARTHRITIS

PAIN GEL

Diclofenac Sodium Topical Gel 1% (NSAID)

Arthritis Pain Reliever

FOR DAILY

TREATMENT OF

ARTHRITIS PAIN

ANTI-INFLAMMATORY

FOR EXTERNAL USE ONLY

NET WT 3.53 OZ (100 g)

Carton label AleveX Pain GelCarton label AleveX Pain Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2550740Aleve Arthritis Pain 1 % Topical GelPSN5
855633diclofenac sodium 1 % Topical GelPSN5
2550740diclofenac sodium 0.01 MG/MG Topical Gel [Aleve Arthritis Pain]SBD5
855633diclofenac sodium 0.01 MG/MG Topical GelSCD5
2550740Aleve Arthritis Pain 0.01 MG/MG Topical GelSY5
2550740Aleve Arthritis Pain 1 % Topical GelSY5
855633diclofenac sodium 1 % Topical GelSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DICLOFENAC Pharmacologic Class Indexing2Indexing - Pharmacologic Class20190118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0039-01Aleve Arthritis Pain Gel1 in 1 CARTONGEL15
0280-0039-01Aleve Arthritis Pain Gel100 g in 1 TUBEGEL1005
0280-0039-02Aleve Arthritis Pain Gel1 in 1 CARTONGEL15
0280-0039-02Aleve Arthritis Pain Gel50 g in 1 TUBEGEL505

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00390280-0039-01, 0280-0039-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211253-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1684e616aacf4f…
2026-08-18 06:07:402026-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A211253-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A211253-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211253-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211253-001AB1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve Arthritis Pain GelDICLOFENAC SODIUMBayer HealthCare LLCbad675d1-1204-0136-e053-2995a90a994e2025-12-04WarningsExact identifier
ndc (package): 0280-0039-02
ndc (package): 0280-0039-01
ndc (product): 0280-0039
ndc11 (package): 00280003901
ndc11 (package): 00280003902
spl id: 452615d3-7d62-4fa6-e063-6394a90a5dfd
spl set id: bad675d1-1204-0136-e053-2995a90a994e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.