Diclofenac sodium

Product NDC: 71085-003
11-digit product format: 710850003
Labeler code: 71085
Product ID: 71085-003_c4f130b9-1e58-4e59-a01d-65cd423645a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: GEL
Route: TOPICAL
Labeler: IPG PHARMACEUTICALS, INC.
Application: ANDA206298
Marketing category: ANDA
Marketing start: 2016-04-28
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71085-003		D	Discontinued by firm		2026-08-03
excluded package	package	71085-003	71085-003-00	D	Discontinued by firm		2026-08-03

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71085-003-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71085-003-00	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71085-003-00	2025-12-29	C162847	48780-1	3b156c62-2e54-fb37-e063-e6dba90a4e07	Diclofenac Sodium Gel, 3%
71085-003-00	2025-07-29	C162847	48780-1	3b156c62-2e54-fb37-e063-e6dba90a4e07	Diclofenac Sodium Gel, 3%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71085-003-00	GM - Gram	71085-003	bc4ded08-fc7a-45be-8b97-321f205420f7	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71085-003	DICLOFENAC SODIUM GEL [IPG PHARMACEUTICALS, INC.]	1	Legacy NDC	20170227_c73b0fd0-50b9-4262-bbef-5f71eef79036.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71085-003-00	71085000300	1 TUBE in 1 CARTON (71085-003-00) > 100 g in 1 TUBE	1 tube	2016-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Gel, 3%	IPG PHARMACEUTICALS, INC. \| Sun Pharma Canada Inc.	2025-12-24	HUMAN PRESCRIPTION DRUG LABEL	3
Diclofenac Sodium Gel, 3%	Preferred Pharmaceuticals, Inc.	2020-05-04	HUMAN PRESCRIPTION DRUG LABEL	2