Diclofenac sodium

Product NDC
51672-1363
11-digit product format
516721363
Labeler code
51672
Product ID
51672-1363_38ef9dc7-662f-056c-e063-6394a90a47e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA206298
Marketing category
ANDA
Marketing start
2016-04-28
Substance
DICLOFENAC SODIUM
Active strength
30 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
A206298-001DICLOFENAC SODIUMDICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206298-001AB

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 UTC2026-02A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A206298-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-04-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206298-001DICLOFENAC SODIUM3%GEL / TOPICALABRS2016-04-28cb3db0bc1861…

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 UTC2026-02A206298-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206298-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206298-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206298-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206298-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206298-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206298-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206298-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206298-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206298-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206298-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206298-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206298-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206298-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206298-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206298-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206298-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206298-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206298-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206298-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206298-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206298-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206298-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206298-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206298-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206298-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206298-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206298-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206298-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206298-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206298-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206298-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206298-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206298-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206298-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206298-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206298-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206298-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206298-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206298-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM30 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
855642Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391Available 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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1363-3Diclofenac sodium1 in 1 CARTONGEL111
51672-1363-3Diclofenac sodium50 g in 1 TUBEGEL5011
51672-1363-7Diclofenac sodium100 g in 1 TUBEGEL10011
51672-1363-7Diclofenac sodium1 in 1 CARTONGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1363-7GM - Gram51672-13634ff7a9dc-0a8c-4108-a053-fe8426027b0a12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1363DICLOFENAC SODIUM GEL [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 4 package rows20250124_aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.71a823c4-9c88-474d-b525-276f9e7808aa2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
DICLOFENAC SODIUMDICLOFENAC SODIUMDirect_Rx946b3799-2d56-12a5-e053-2a95a90aeba02026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
Diclofenac sodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.aa1e1ed3-0444-4bf5-a0ee-5d21a7fca3912025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
ndc (product): 51672-1363
Diclofenac sodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.81bfeada-6589-4528-bea5-059ab0fabb432025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7264-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.22f4b8aa-902f-a860-e063-6394a90ada262024-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb98d921a-2ee7-4770-ac21-d845b2dcc11c2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.d4b81a74-6926-4715-bf90-aec026cff2b42022-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206298
application number: ANDA206298

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSNaa1e1ed3-0444-4bf5-a0ee-5d21a7fca39111
855642diclofenac sodium 0.03 MG/MG Topical GelSCDaa1e1ed3-0444-4bf5-a0ee-5d21a7fca39111
855642diclofenac sodium 3 % Topical GelSYaa1e1ed3-0444-4bf5-a0ee-5d21a7fca39111
855642diclofenac sodium 3 % Topical GelPSN81bfeada-6589-4528-bea5-059ab0fabb434
855642diclofenac sodium 0.03 MG/MG Topical GelSCD81bfeada-6589-4528-bea5-059ab0fabb434
855642diclofenac sodium 3 % Topical GelSY81bfeada-6589-4528-bea5-059ab0fabb434
855642diclofenac sodium 3 % Topical GelPSNf1892aae-7264-3b4c-e053-2995a90a88023
855642diclofenac sodium 0.03 MG/MG Topical GelSCDf1892aae-7264-3b4c-e053-2995a90a88023
855642diclofenac sodium 3 % Topical GelSYf1892aae-7264-3b4c-e053-2995a90a88023
855642diclofenac sodium 3 % Topical GelPSN946b3799-2d56-12a5-e053-2a95a90aeba02
855642diclofenac sodium 3 % Topical GelPSNb98d921a-2ee7-4770-ac21-d845b2dcc11c2
855642diclofenac sodium 0.03 MG/MG Topical GelSCD946b3799-2d56-12a5-e053-2a95a90aeba02
855642diclofenac sodium 0.03 MG/MG Topical GelSCDb98d921a-2ee7-4770-ac21-d845b2dcc11c2
855642diclofenac sodium 3 % Topical GelSY946b3799-2d56-12a5-e053-2a95a90aeba02
855642diclofenac sodium 3 % Topical GelSYb98d921a-2ee7-4770-ac21-d845b2dcc11c2
855642diclofenac sodium 3 % Topical GelPSN22f4b8aa-902f-a860-e063-6394a90ada261
855642diclofenac sodium 3 % Topical GelPSN14a85a88-c941-94ea-e063-6394a90a4e141
855642diclofenac sodium 3 % Topical GelPSNe6f7a2b0-7d1b-4cf0-8d8d-47b762164f071
855642diclofenac sodium 3 % Topical GelPSNd4b81a74-6926-4715-bf90-aec026cff2b41
855642diclofenac sodium 0.03 MG/MG Topical GelSCD14a85a88-c941-94ea-e063-6394a90a4e141
855642diclofenac sodium 0.03 MG/MG Topical GelSCDe6f7a2b0-7d1b-4cf0-8d8d-47b762164f071
855642diclofenac sodium 0.03 MG/MG Topical GelSCDd4b81a74-6926-4715-bf90-aec026cff2b41
855642diclofenac sodium 0.03 MG/MG Topical GelSCD22f4b8aa-902f-a860-e063-6394a90ada261
855642diclofenac sodium 3 % Topical GelSYd4b81a74-6926-4715-bf90-aec026cff2b41
855642diclofenac sodium 3 % Topical GelSYe6f7a2b0-7d1b-4cf0-8d8d-47b762164f071
855642diclofenac sodium 3 % Topical GelSY14a85a88-c941-94ea-e063-6394a90a4e141
855642diclofenac sodium 3 % Topical GelSY22f4b8aa-902f-a860-e063-6394a90ada261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1363-3516721363031 TUBE in 1 CARTON (51672-1363-3) / 50 g in 1 TUBE1 tube2016-04-280000-00-00NoNoCurrent
51672-1363-7516721363071 TUBE in 1 CARTON (51672-1363-7) / 100 g in 1 TUBE1 tube2016-04-280000-00-00NoNoCurrent