DICLOFENAC SODIUM

Product NDC
43598-977
Requested package NDC
43598-977-10
11-digit product format
435980977
Labeler code
43598
Product ID
43598-977_affe6a89-16fb-8b78-d0db-1f7f8a818ea7
Type
HUMAN OTC DRUG
Nonproprietary name
diclofenac sodium topical gel, 1%
Dosage form
GEL
Route
TOPICAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA210986
Marketing category
ANDA
Marketing start
2020-09-14
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
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 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
A210986-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210986-001DICLOFENAC SODIUM1%GEL / TOPICAL2020-01-27a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
DICLOFENAC SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03abebd6-426a-9d05-3dff-196477389430Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-977-10VennGel II100 g in 1 TUBEGEL100 g10 mg in 1g2
43598-977-10VennGel II1 in 1 CARTONGEL10 mg in 1g2
43598-977-10Diclolidol Kit1 in 1 CARTONGEL10 mg in 1g1
43598-977-10Diclolidol Kit100 g in 1 TUBEGEL1 g in 10010 mg in 1g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-977-10GM - Gram43598-977483f00b3-6ed1-4870-95e2-d35f7657832612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-977DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC20250316_03abebd6-426a-9d05-3dff-196477389430.zip
43598-977VENNGEL II (DICLOFENAC SODIUM, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20250303_2e70d8e9-9678-2d51-e063-6294a90aca64.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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUM 1%Sportpharm LLC391d9d0b-74b7-4359-aea0-d3bb8c8d3cd12026-07-10WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,Preferred Pharmaceuticals, Inc.aee20924-79ab-400e-b9b6-4189789146542026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Sportpharm LLCa133d18e-981d-43b7-bef1-7869f7c7d9a72026-02-09WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclofenac SodiumDICLOFENAC SODIUM 1%Asclemed USA, Inc.6952a221-17fd-4592-8edc-ff36997435332026-01-13WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Aspercreme ArthritisDICLOFENAC SODIUMChattem, Inc.81f78685-c416-48b5-8840-eef03a66bc282026-01-12WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclofenac SodiumDICLOFENAC SODIUM 1%SOLA Pharmaceuticalsbdbe3f24-3015-1f32-e053-2995a90aa6652025-12-08WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclofenac Sodium Topical 1%DICLOFENAC SODIUMYYBA CORP043df5d2-6f3e-311f-e063-6294a90a23d72025-11-10WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.c88b2512-0255-658d-252a-c006275159b02025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Arthritis PainDICLOFENAC SODIUM TOPICAL GEL, 1%Strategic Sourcing Services, LLC5de514ee-fd59-ef95-8dc3-16e34321572b2025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Chain Drug Marketing Association INC625d21e8-0731-1157-30fe-9f9868ff8dc42025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL, 1%Walgreens Company40d0553b-a97a-1315-3fca-8ef38611505e2025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Arthritis PainDICLOFENAC SODIUM TOPICAL GEL, 1%Discount Drug Mart, Inc.ae1ebe9c-b1fa-6762-949e-cb83b33319a22025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclofenac Sodium Topical Gel 1%DICLOFENAC SODIUM TOPICAL GEL, 1%Kroger Company2081371d-436a-16fc-db80-ced6288f52bc2025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%GERI-CARE PHARMACEUTICALS CORP91fc618a-edd0-5944-083f-c00075476f552025-10-28WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Encube Ethicals, Inc.6e8c45e1-8cd4-4ff7-a758-f9d2ed37e5932025-10-01WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
Diclolidol KitLIDOCAINE HCL, DICLOFENAC SODIUMPureTek Corporation3e63324b-e761-9367-e063-6394a90a29812025-09-09Warnings, Adverse reactionsExact identifier
ndc (package): 43598-977-10
ndc11 (package): 43598097710
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%BluePoint Laboratories274543d2-a9a6-1e37-e063-6394a90ae3f12025-08-11WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Dr. Reddy's Laboratories Inc.03abebd6-426a-9d05-3dff-1964773894302025-05-05WarningsExact identifier
application applno (ANDA): 210986
application number: ANDA210986
ndc (package): 43598-977-10
ndc (product): 43598-977
ndc11 (package): 43598097710
VennGel IIDICLOFENAC SODIUM, ISOPROPYL ALCOHOLPureTek Corporation2e70d8e9-9678-2d51-e063-6294a90aca642025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 43598-977-10
ndc11 (package): 43598097710
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxfce9b3eb-ae79-a090-e053-6294a90ad20e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210986
application number: ANDA210986

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN03abebd6-426a-9d05-3dff-1964773894306
855633diclofenac sodium 1 % Topical GelPSNc88b2512-0255-658d-252a-c006275159b06
855633diclofenac sodium 0.01 MG/MG Topical GelSCD03abebd6-426a-9d05-3dff-1964773894306
855633diclofenac sodium 0.01 MG/MG Topical GelSCDc88b2512-0255-658d-252a-c006275159b06
855633diclofenac sodium 1 % Topical GelSY03abebd6-426a-9d05-3dff-1964773894306
855633diclofenac sodium 1 % Topical GelSYc88b2512-0255-658d-252a-c006275159b06
855633diclofenac sodium 1 % Topical GelPSN2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 0.01 MG/MG Topical GelSCD2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 1 % Topical GelSY2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 1 % Topical GelPSN3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 1 % Topical GelPSNa133d18e-981d-43b7-bef1-7869f7c7d9a71
855633diclofenac sodium 1 % Topical GelPSNb4694451-a13d-484e-92c4-c03a6fcbb5111
1010057lidocaine HCl 5 % Topical GelPSN3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 0.01 MG/MG Topical GelSCD3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 0.01 MG/MG Topical GelSCDa133d18e-981d-43b7-bef1-7869f7c7d9a71
855633diclofenac sodium 0.01 MG/MG Topical GelSCDb4694451-a13d-484e-92c4-c03a6fcbb5111
1010057lidocaine hydrochloride 0.05 MG/MG Topical GelSCD3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 1 % Topical GelSY3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 1 % Topical GelSYa133d18e-981d-43b7-bef1-7869f7c7d9a71
855633diclofenac sodium 1 % Topical GelSYb4694451-a13d-484e-92c4-c03a6fcbb5111
1010057lidocaine hydrochloride 5 % Topical GelSY3e63324b-e761-9367-e063-6394a90a29811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-977-10435980977101 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE1 tube2020-09-140000-00-00NoNoCurrent