Diclofenac Sodium

Product NDC: 80425-0235
11-digit product format: 804250235
Labeler code: 80425
Product ID: 80425-0235_2a9aec09-6308-2252-e063-6294a90a204a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA206298
Marketing category: ANDA
Marketing start: 2023-01-10
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206298-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206298-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206298-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	RS	2016-04-28	`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	A206298-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206298-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206298-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206298-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206298-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206298-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206298-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206298-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206298-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206298-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206298-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206298-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206298-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206298-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206298-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206298-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206298-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206298-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206298-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206298-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206298-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206298-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206298-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206298-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206298-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206298-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206298-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206298-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206298-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206298-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206298-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206298-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206298-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206298-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206298-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206298-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206298-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206298-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206298-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206298-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
f1892aae-7264-3b4c-e053-2995a90a8802	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
80425-0235-1	Diclofenac Sodium	100 g in 1 TUBE	GEL	100		3
80425-0235-1	Diclofenac Sodium	1 in 1 CARTON	GEL	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0235-1	GM - Gram	80425-0235	570cb8c5-6d52-4d1c-baa7-12cb101ef49b	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0235	DICLOFENAC SODIUM GEL [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20250102_f1892aae-7264-3b4c-e053-2995a90a8802.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	71a823c4-9c88-474d-b525-276f9e7808aa	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Direct_Rx	946b3799-2d56-12a5-e053-2a95a90aeba0	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
Diclofenac sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	81bfeada-6589-4528-bea5-059ab0fabb43	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7264-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298 ndc (product): 80425-0235
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	22f4b8aa-902f-a860-e063-6394a90ada26	2024-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b98d921a-2ee7-4770-ac21-d845b2dcc11c	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298
Diclofenac sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	d4b81a74-6926-4715-bf90-aec026cff2b4	2022-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206298 application number: ANDA206298

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	f1892aae-7264-3b4c-e053-2995a90a8802	3
855642	diclofenac sodium 0.03 MG/MG Topical Gel	SCD	f1892aae-7264-3b4c-e053-2995a90a8802	3
855642	diclofenac sodium 3 % Topical Gel	SY	f1892aae-7264-3b4c-e053-2995a90a8802	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0235-1	80425023501	1 TUBE in 1 CARTON (80425-0235-1) / 100 g in 1 TUBE	1 tube	2023-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Gel	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3