Voltaren

Product NDC
68387-456
11-digit product format
683870456
Labeler code
68387
Product ID
68387-456_9c160477-60c6-4f71-9269-48432b6799f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Keltman Pharmaceuticals Inc.
Application
NDA022122
Marketing category
NDA
Marketing start
2011-01-27
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68387-456IInactivated by FDA2026-08-07
excluded packagepackage68387-45668387-456-01IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68387-456-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68387-456-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68387-456-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68387-456-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68387-456-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68387-456-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68387-456-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68387-456-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68387-456-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68387-456-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68387-456-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68387-456-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68387-456-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68387-456-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68387-456-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68387-456-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68387-456-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68387-456-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68387-456-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68387-456-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68387-456-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68387-456-01110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022122-001VOLTAREN ARTHRITIS PAIN1%GEL / TOPICALRLD, RS2007-10-17cb3db0bc1861…

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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-456-01Voltaren100 g in 1 TUBEGEL1001
68387-456-01Voltaren1 in 1 CARTONGEL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-456-01GM - Gram68387-456af632620-0ae6-412b-90b3-45d3bc2cc92612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-456VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20110712_26b2d99e-d471-4758-8aa0-a26ef464eb35.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
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 GelPSN26b2d99e-d471-4758-8aa0-a26ef464eb351
855635Voltaren 1 % Topical GelPSN26b2d99e-d471-4758-8aa0-a26ef464eb351
855635diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]SBD26b2d99e-d471-4758-8aa0-a26ef464eb351
855633diclofenac sodium 0.01 MG/MG Topical GelSCD26b2d99e-d471-4758-8aa0-a26ef464eb351
855633diclofenac sodium 1 % Topical GelSY26b2d99e-d471-4758-8aa0-a26ef464eb351
855635Voltaren 0.01 MG/MG Topical GelSY26b2d99e-d471-4758-8aa0-a26ef464eb351
855635Voltaren 1 % Topical GelSY26b2d99e-d471-4758-8aa0-a26ef464eb351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68387-456-0168387045601100 g in 1 TUBE100 gHistorical