Voltaren

Product NDC
0067-8154
11-digit product format
000678154
Labeler code
0067
Product ID
0067-8154_71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c
Type
HUMAN OTC DRUG
Nonproprietary name
diclofenac sodium
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
NDA022122
Marketing category
NDA
Marketing start
2025-02-19
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17e64feba35796…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Voltaren
Brand name suffix
Arthritis Pain
Listing expiration
2026-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855633Internal RxNorm lookup
855635Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30a94282-0892-442a-aa10-6525cbd4fe88Available on FDA.report

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 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
0067-8154VOLTAREN 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

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 · 2 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
application applno (NDA): 022122
application number: NDA022122
ndc (product): 0067-8154
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPa7447467-79e0-436e-a273-d1ddd06169cf2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022122
application number: NDA022122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN30a94282-0892-442a-aa10-6525cbd4fe8813
855635Voltaren 1 % Topical GelPSN30a94282-0892-442a-aa10-6525cbd4fe8813
855635diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]SBD30a94282-0892-442a-aa10-6525cbd4fe8813
855633diclofenac sodium 0.01 MG/MG Topical GelSCD30a94282-0892-442a-aa10-6525cbd4fe8813
855633diclofenac sodium 1 % Topical GelSY30a94282-0892-442a-aa10-6525cbd4fe8813
855635Voltaren 0.01 MG/MG Topical GelSY30a94282-0892-442a-aa10-6525cbd4fe8813
855635Voltaren 1 % Topical GelSY30a94282-0892-442a-aa10-6525cbd4fe8813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-8152-010006781520120 g in 1 TUBE20 gHistorical
0067-8152-03000678152031 in 1 CARTONHistorical
0067-8154-01000678154011 KIT in 1 CARTON (0067-8154-01) * 1 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE * 1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE1 kit2025-02-19NoNoCurrent