FDA.reportPublic FDA data

Voltaren

Manufacturer
Haleon US Holdings LLC
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:55:31

Label at a glance#

ProductVoltaren Arthritis Pain
Active ingredientDICLOFENAC SODIUM
Label structure13 sections

Indications and uses

• 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.

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....

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Arthritis pain reliever

Uses

INDICATIONS & USAGE SECTION

  • 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.

Warnings

WARNINGS SECTION

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

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 age 18 years.

Ask a doctor or pharmacist before use if you are

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

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:

INSTRUCTIONS FOR USE SECTION

  • 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 Voltaren Arthritis Pain. The dosing card 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 homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Additional Information

SPL UNCLASSIFIED SECTION

ORIGINAL PRESCRIPTION STRENGTH

Medicated Gel Clinically Proven to Relieve Arthritis Pain

TREATMENT AREAS

  • Hand Wrist Elbow Foot Ankle Knee
  • Not for use on any other body area (such as back, hip, or shoulder)

Use Enclosed Dosing Card to Measure a Dose

Voltaren ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) – arthritis pain reliever

Dosing Card (NOT ACTUAL SIZE)

Read product User Guide before use

Not for immediate pain relief

Upper body dose 2.25 inches long (2 grams)

Lower body dose 4.5 inches long (4 grams)

How to Use:

  • For arthritis pain only
  • Use 4 times a day
  • May take up to 7 days to work for your arthritis pain
  • For use on no more than 2 body areas
  • Use up to 21 days unless directed by your doctor
  • Screw Cap Tamper evident statement: Do not use if safety seal on tube nozzle is broken or missing.
  • Flip Cap Tamper evident statement: Do not use if plastic safety seals on sides of cap are broken or missing.

Principal Display Panel (50 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Voltaren

ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever

ANTI-INFLAMMATORY

For Daily Treatment of Arthritis Pain

For external use only

NET WT 50 g (1.76 oz)

Voltaren gel 50 g
Voltaren gel 50 g

Principal Display Panel (150 g + 150 g + 50 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH

Voltaren

ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever

ANTI-INFLAMMATORY

For Daily Treatment of Arthritis Pain

Medicated Gel Clinically Proven to Relieve Arthritis Pain

NEW FLIP TOP CAP*

*Cap for 150 g only

For external use only

TREATMENT AREAS

  • Hand Wrist Elbow Foot Ankle Knee
  • Not for use on any other body area (such as back, hip, or shoulder)
  • 3 TUBES: 150 g + 150 g + 50 g TOTAL NET WT 350 g (12.34 oz)
204419 Voltaren Arthritis Pain 350g (12.34 oz) backercard
204419 Voltaren Arthritis Pain 350g (12.34 oz) backercard

Principal Display Panel (100 g + 20 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREE 20 g* TRAVEL SIZE

*WITH PURCHASE OF 100 g TUBE

ORIGINAL PRESCRIPTION STRENGTH

Voltaren

ARTHRITIS PAIN

Diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever

ANTI-INFLAMMATORY

For Daily Treatment of Arthritis Pain

FLIP-TOP CAP†

†Cap for 100 g only

For external use only

100 g + 20 g TOTAL NET WT 120 g (4.23 oz)

Voltaren Kit 100 g plus 20 g
Voltaren Kit 100 g plus 20 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855633diclofenac sodium 1 % Topical GelPSN13
855635Voltaren 1 % Topical GelPSN13
855635diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]SBD13
855633diclofenac sodium 0.01 MG/MG Topical GelSCD13
855633diclofenac sodium 1 % Topical GelSY13
855635Voltaren 0.01 MG/MG Topical GelSY13
855635Voltaren 1 % Topical GelSY13

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0067-8152-01VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-01VoltarenArthritis Pain20 g in 1 TUBEGEL2013
0067-8152-02VoltarenArthritis Pain50 g in 1 TUBEGEL5013
0067-8152-02VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-03VoltarenArthritis Pain100 g in 1 TUBEGEL10013
0067-8152-03VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-04VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-04VoltarenArthritis Pain150 g in 1 TUBEGEL15013
0067-8152-05VoltarenArthritis Pain150 g in 1 TUBEGEL15013
0067-8152-05VoltarenArthritis Pain3 in 1 CARTONGEL313
0067-8152-08VoltarenArthritis Pain100 g in 1 TUBEGEL10013
0067-8152-08VoltarenArthritis Pain2 in 1 CARTONGEL213
0067-8152-09VoltarenArthritis Pain20 g in 1 TUBEGEL2013
0067-8152-09VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8153-01VoltarenArthritis Pain1 in 1 CARTONKIT113
0067-8152-01VoltarenArthritis Pain20 g in 1 TUBEGEL1 g10 mg in 1g13
0067-8152-01VoltarenArthritis Pain1 in 1 CARTONGEL10 mg in 1g13
0067-8152-03VoltarenArthritis Pain1 in 1 CARTONGEL10 mg in 1g13
0067-8152-03VoltarenArthritis Pain100 g in 1 TUBEGEL1 g10 mg in 1g13
0067-8154-01VoltarenArthritis Pain1 in 1 CARTONKIT113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8152VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 14 package rows20250221_30a94282-0892-442a-aa10-6525cbd4fe88.zip
0067-8153VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 1 package rows20250221_30a94282-0892-442a-aa10-6525cbd4fe88.zip
0067-8154VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [HALEON US HOLDINGS LLC]13Current NDC, 5 package rows20250221_30a94282-0892-442a-aa10-6525cbd4fe88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8152-02GM - Gram0067-8152da597a77-f9db-46bb-8368-0c2105ebcaf312020-06-05
0067-8152-03GM - Gram0067-81523599c9ac-1030-4b1e-bac1-159d39012a1a12020-06-05
0067-8152-04GM - Gram0067-815245daba01-e185-435f-8e9c-592e3d72ae6012020-06-05
0067-8152-08GM - Gram0067-8152badbb74e-b64a-4367-878d-4c15f1dacd7312024-10-04
0067-8153-01GM - Gram0067-8153504abe4b-f2a6-49c2-aefd-65dfc379cd6b12020-08-06

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
0067-81520067-8152-01, 0067-8152-02, 0067-8152-03, 0067-8152-04, 0067-8152-05, 0067-8152-08, 0067-8152-09
0067-81530067-8153-01
0067-81540067-8154-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICLOFENAC SODIUMQTG126297QACTIB
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ISOPROPYL ALCOHOLND2M416302IACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DICLOFENAC SODIUMQTG126297QACTIB
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ISOPROPYL ALCOHOLND2M416302IACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DICLOFENAC SODIUMQTG126297QACTIB
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ISOPROPYL ALCOHOLND2M416302IACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DICLOFENAC SODIUMQTG126297QACTIB
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ISOPROPYL ALCOHOLND2M416302IACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DICLOFENAC SODIUMQTG126297QACTIB
AMMONIA5138Q19F1XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT

Source Document#

Source XML · Source PDF

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 44.

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
N022122-001VOLTAREN ARTHRITIS PAINDICLOFENAC SODIUM1%GEL / TOPICALRLD, RS2007-10-17

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17c2088c7a36db…
2026-09-14 22:38:342026-08N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-1784e616aacf4f…
2026-08-18 06:07:402026-07N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022122-001VOLTAREN1%GEL / TOPICALABRLD, RS2007-10-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022122-001VOLTAREN1%GEL / TOPICALABRLD, RS2007-10-173f01610625f2…
2019-09-15 20:21 UTC2019-09N022122-001VOLTAREN1%GEL / TOPICALABRLD, RS2007-10-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N022122-001VOLTAREN1%GEL / TOPICALABRLD, RS2007-10-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-173a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N022122-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N022122-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022122-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022122-001AB1ea99ee380514…

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
Voltaren Arthritis PainDICLOFENAC SODIUMHaleon US Holdings LLC30a94282-0892-442a-aa10-6525cbd4fe882025-02-11WarningsExact identifier
ndc (package): 0067-8152-09
ndc (package): 0067-8152-08
ndc (package): 0067-8152-01
ndc (package): 0067-8154-01
ndc (package): 0067-8152-04
ndc (package): 0067-8153-01
ndc (package): 0067-8152-05
ndc (package): 0067-8152-02
ndc (package): 0067-8152-03
ndc (product): 0067-8154
ndc (product): 0067-8152
ndc (product): 0067-8153
ndc11 (package): 00067815205
ndc11 (package): 00067815201
ndc11 (package): 00067815203
ndc11 (package): 00067815208
ndc11 (package): 00067815202
ndc11 (package): 00067815401
ndc11 (package): 00067815204
ndc11 (package): 00067815301
ndc11 (package): 00067815209
spl id: 71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c
spl set id: 30a94282-0892-442a-aa10-6525cbd4fe88

Reported adverse events (FAERS/openFDA)#

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