DICLOFENAC SODIUM

Product NDC: 71085-084
11-digit product format: 710850084
Labeler code: 71085
Product ID: 71085-084_5bc5c7d8-1eb1-d536-e063-6294a90a7876
Type: HUMAN OTC DRUG
Nonproprietary name: diclofenac sodium topical gel, 1%
Dosage form: GEL
Route: TOPICAL
Labeler: IPG Pharmaceuticals, inc.
Application: ANDA210986
Marketing category: ANDA
Marketing start: 2026-09-06
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210986-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2020-01-27

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210986-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	2020-01-27	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: DICLOFENAC SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	10 mg/g

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	A-S Medication Solutions	4500bf3c-394b-4397-8751-8dac2097fc41	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Gencare-Arthritis Pain Relief	DICLOFENAC SODIUM	Pioneer Life Sciences, LLC	4b1438bb-8591-4237-abcb-91491f34ad8f	2024-09-10	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	NuCare Pharmaceuticals,Inc.	0326ea5b-3e1a-dee2-e063-6294a90a13b8	2024-07-09	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Curist Arthritis Relief	DICLOFENAC SODIUM	Little Pharma, Inc.	e638a98e-e6d7-36ed-e053-2995a90af2ca	2024-06-21	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Simple Diagnostics	13925cd5-e121-80d2-e063-6394a90af9a9	2024-03-19	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	A-S Medication Solutions	828b5de2-77a7-4893-ab47-dffc8ea73693	2023-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Crcle Diclofenac Sodium Topical Gel 1%	DICLOFENAC SODIUM TOPICAL GEL 1%	Innovus Pharmaceuticals Inc.	b373c202-5795-418f-989c-1ec5837145af	2023-03-24	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Proficient Rx LP	b4694451-a13d-484e-92c4-c03a6fcbb511	2023-01-01	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	Proficient Rx LP	7e98952e-9b95-4296-9c23-c0ff4b82b2b7	2021-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	Asclemed USA, Inc.	988abe66-0b3b-4c13-87b4-adc913227fc5	2020-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986

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	Sample	Exclude flag	Status
71085-084-03	71085008403	1 TUBE in 1 CARTON (71085-084-03) / 110 g in 1 TUBE	1 tube	2026-09-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever	IPG Pharmaceuticals, inc.	2026-09-18	HUMAN OTC DRUG LABEL	1