Diclofenac Sodium Gel

Product NDC: 72189-379
Requested package NDC: 72189-379-01
11-digit product format: 721890379
Labeler code: 72189
Product ID: 72189-379_4d3a653e-054e-4554-e063-6294a90a1239
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium Gel
Dosage form: GEL
Route: TOPICAL
Labeler: Direct_Rx
Application: ANDA208301
Marketing category: ANDA
Marketing start: 2022-09-08
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: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-379	72189-379-01	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-379	72189-379-01	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208301-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-09-13

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208301-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208301-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208301-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208301-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208301-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208301-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208301-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208301-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208301-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium Gel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855642	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e82e4d34-bdaa-b950-e053-2995a90a29f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-379-01	Diclofenac Sodium Gel	1 g in 1 TUBE	GEL	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-379-01	GM - Gram	72189-379	7e01ea4e-7911-40d4-a070-fe0302b7e5da	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-379	DICLOFENAC SODIUM GEL GEL [DIRECT_RX]	3	Current NDC, Legacy NDC, 1 package rows	20250123_e82e4d34-bdaa-b950-e053-2995a90a29f1.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	96f8c42c-db34-43b0-a891-33dd8e39e74f	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	5d0a4b41-afbf-45e7-bb1c-587d72314ee0	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
Diclofenac Sodium Gel	DICLOFENAC SODIUM GEL	Direct_Rx	e82e4d34-bdaa-b950-e053-2995a90a29f1	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (package): 72189-379-01 ndc (product): 72189-379 ndc11 (package): 72189037901
DICLOFENAC SODIUM	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	06862cf2-9537-6661-e063-6294a90a2084	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	GLENMARK PHARMACEUTICALS INC., USA	dab3ae60-0135-43b3-a1d0-8752720af82a	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7267-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Proficient Rx LP	f19bf286-f4dd-4491-90c3-9f8713071903	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Asclemed USA, Inc.	57d8513a-820a-46c5-b0c8-5aa1811b0e88	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855642	diclofenac sodium 3 % Topical Gel	PSN	e82e4d34-bdaa-b950-e053-2995a90a29f1	4
855642	diclofenac sodium 0.03 MG/MG Topical Gel	SCD	e82e4d34-bdaa-b950-e053-2995a90a29f1	4
855642	diclofenac sodium 3 % Topical Gel	SY	e82e4d34-bdaa-b950-e053-2995a90a29f1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-379-01	72189037901	1 g in 1 TUBE (72189-379-01)	1 g	2022-09-08	0000-00-00	No	No	Current