DICLOFENAC SODIUM

Product NDC
53149-4901
Requested package NDC
53149-4901-1
11-digit product format
531494901
Labeler code
53149
Product ID
53149-4901_88f33e85-6bf1-4f3f-b46b-39ff6509edc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
All Pharma, LLC
Application
ANDA208301
Marketing category
ANDA
Marketing start
2016-09-13
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53149-490153149-4901-1IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A208301-001DICLOFENAC SODIUMDICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208301-001AB

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 UTC2026-02A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133f01610625f2…
2019-09-15 20:21 UTC2019-09A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208301-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208301-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208301-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208301-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208301-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208301-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208301-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208301-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208301-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208301-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208301-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208301-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208301-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208301-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208301-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208301-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208301-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208301-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208301-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208301-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208301-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208301-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208301-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208301-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208301-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208301-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208301-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208301-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208301-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208301-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208301-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208301-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208301-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208301-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208301-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208301-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208301-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208301-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208301-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208301-001AB1cb3db0bc1861…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53149-4901-12022-01-28C16284748780-1d6a99b39-b9da-a426-e053-dadaa90af4c2DICLOFENAC SODIUM GEL, 3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4901-1DICLOFENAC SODIUM100 g in 1 TUBEGEL1005
53149-4901-1DICLOFENAC SODIUM1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-4901-1GM - Gram53149-4901eecbbb96-2e07-4808-aec7-a7c4e95ad0ea12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4901DICLOFENAC SODIUM GEL [ALL PHARMA, LLC]5Legacy NDC, 2 package rows20200117_a90e04dc-8ede-4852-9ea5-45bd249dfa1f.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMHAWAII REPACK, INCea113a58-c7ed-4768-9777-93d9b166dfbe2026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.96f8c42c-db34-43b0-a891-33dd8e39e74f2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.5d0a4b41-afbf-45e7-bb1c-587d72314ee02026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxe82e4d34-bdaa-b950-e053-2995a90a29f12026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.06862cf2-9537-6661-e063-6294a90a20842026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMGLENMARK PHARMACEUTICALS INC., USAdab3ae60-0135-43b3-a1d0-8752720af82a2025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7267-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMProficient Rx LPf19bf286-f4dd-4491-90c3-9f87130719032023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMAsclemed USA, Inc.57d8513a-820a-46c5-b0c8-5aa1811b0e882020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSNa90e04dc-8ede-4852-9ea5-45bd249dfa1f5
855642diclofenac sodium 0.03 MG/MG Topical GelSCDa90e04dc-8ede-4852-9ea5-45bd249dfa1f5
855642diclofenac sodium 3 % Topical GelSYa90e04dc-8ede-4852-9ea5-45bd249dfa1f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53149-4901-1531494901011 TUBE in 1 CARTON (53149-4901-1) > 100 g in 1 TUBE1 tube2018-09-060000-00-00NoNoCurrent