Diclofenac Sodium

Product NDC
49884-935
11-digit product format
498840935
Labeler code
49884
Product ID
49884-935_5573200b-bb6a-4197-9f5d-bff47f824ddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Par Pharmaceutical Inc
Application
NDA022122
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-07-01
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
No
Listing certified through
2021-12-31
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 productproduct49884-935IInactivated by FDA2026-08-07
excluded packagepackage49884-93549884-935-47DDiscontinued by firm2026-08-07

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 · 35 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-935-47DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-935-47DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-935-47DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-935-47DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-935-47DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-935-47DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-935-47DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-935-47DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-935-47DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-935-47DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-935-47DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-935-47DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49884-935-47IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49884-935-47IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49884-935-47IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49884-935-47IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

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
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
49884-935-47Diclofenac Sodium1 in 1 CARTONGEL16
49884-935-47Diclofenac Sodium100 g in 1 TUBEGEL1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-935DICLOFENAC SODIUM GEL [PAR PHARMACEUTICAL INC]6Legacy NDC, 2 package rows20200312_d240f348-8a14-4f62-9815-a760f02b4f4f.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 GelPSN721fceb7-25c6-43bc-85a7-58ac4a525d3b7
855633diclofenac sodium 0.01 MG/MG Topical GelSCD721fceb7-25c6-43bc-85a7-58ac4a525d3b7
855633diclofenac sodium 1 % Topical GelSY721fceb7-25c6-43bc-85a7-58ac4a525d3b7
855633diclofenac sodium 1 % Topical GelPSNd240f348-8a14-4f62-9815-a760f02b4f4f6
855633diclofenac sodium 0.01 MG/MG Topical GelSCDd240f348-8a14-4f62-9815-a760f02b4f4f6
855633diclofenac sodium 1 % Topical GelSYd240f348-8a14-4f62-9815-a760f02b4f4f6
855633diclofenac sodium 1 % Topical GelPSNa7447467-79e0-436e-a273-d1ddd06169cf3
855633diclofenac sodium 0.01 MG/MG Topical GelSCDa7447467-79e0-436e-a273-d1ddd06169cf3
855633diclofenac sodium 1 % Topical GelSYa7447467-79e0-436e-a273-d1ddd06169cf3
855633diclofenac sodium 1 % Topical GelPSN5c264f39-d23f-4bfb-9b67-fb7b005bbb441
855633diclofenac sodium 0.01 MG/MG Topical GelSCD5c264f39-d23f-4bfb-9b67-fb7b005bbb441
855633diclofenac sodium 1 % Topical GelSY5c264f39-d23f-4bfb-9b67-fb7b005bbb441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-935-47498840935471 TUBE in 1 CARTON (49884-935-47) > 100 g in 1 TUBE1 tube2016-07-012022-11-30NoNoCurrent