Diclofenac Sodium

Product NDC: 70518-2813
11-digit product format: 705182813
Labeler code: 70518
Product ID: 70518-2813_e38a4aa0-03c1-6cbf-e053-2995a90a1b20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium Topical Gel, 1%,
Dosage form: GEL
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA210986
Marketing category: ANDA
Marketing start: 2020-07-13
Marketing end: 0000-00-00
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: 2023-12-31
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	70518-2813		D	Discontinued by firm		2026-08-03
excluded package	package	70518-2813	70518-2813-0	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 · 22 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	70518-2813-0	`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	70518-2813-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2813-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2813-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2813-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2813-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2813-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2813-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2813-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2813-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2813-0	`367a005e9d99…`	`383a685ebd0f…`

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
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
2026-02-19 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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2813-0	2022-02-04	C162847	48780-1	d6a99b39-5f71-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1% for topical use only Initial U.S. Approval: 1988
70518-2813-0	2022-01-28	C162847	48780-1	d6a99b39-5f71-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1% for topical use only Initial U.S. Approval: 1988

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Sportpharm LLC	391d9d0b-74b7-4359-aea0-d3bb8c8d3cd1	2026-07-10	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	Preferred Pharmaceuticals, Inc.	aee20924-79ab-400e-b9b6-418978914654	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Sportpharm LLC	a133d18e-981d-43b7-bef1-7869f7c7d9a7	2026-02-09	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM 1%	Asclemed USA, Inc.	6952a221-17fd-4592-8edc-ff3699743533	2026-01-13	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	81f78685-c416-48b5-8840-eef03a66bc28	2026-01-12	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM 1%	SOLA Pharmaceuticals	bdbe3f24-3015-1f32-e053-2995a90aa665	2025-12-08	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium Topical 1%	DICLOFENAC SODIUM	YYBA CORP	043df5d2-6f3e-311f-e063-6294a90a23d7	2025-11-10	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Dr. Reddy's Laboratories Inc.	c88b2512-0255-658d-252a-c006275159b0	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Arthritis Pain	DICLOFENAC SODIUM TOPICAL GEL, 1%	Strategic Sourcing Services, LLC	5de514ee-fd59-ef95-8dc3-16e34321572b	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Chain Drug Marketing Association INC	625d21e8-0731-1157-30fe-9f9868ff8dc4	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium Topical Gel 1%	DICLOFENAC SODIUM TOPICAL GEL, 1%	Walgreens Company	40d0553b-a97a-1315-3fca-8ef38611505e	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Arthritis Pain	DICLOFENAC SODIUM TOPICAL GEL, 1%	Discount Drug Mart, Inc.	ae1ebe9c-b1fa-6762-949e-cb83b33319a2	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium Topical Gel 1%	DICLOFENAC SODIUM TOPICAL GEL, 1%	Kroger Company	2081371d-436a-16fc-db80-ced6288f52bc	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	GERI-CARE PHARMACEUTICALS CORP	91fc618a-edd0-5944-083f-c00075476f55	2025-10-28	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Encube Ethicals, Inc.	6e8c45e1-8cd4-4ff7-a758-f9d2ed37e593	2025-10-01	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	BluePoint Laboratories	274543d2-a9a6-1e37-e063-6394a90ae3f1	2025-08-11	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Dr. Reddy's Laboratories Inc.	03abebd6-426a-9d05-3dff-196477389430	2025-05-05	Warnings	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium Gel	DICLOFENAC SODIUM GEL	Direct_Rx	fce9b3eb-ae79-a090-e053-6294a90ad20e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	ad193f94-f8d0-8482-e053-2995a90a35a4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210986 application number: ANDA210986
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f3d27ae6-1259-5375-e053-2995a90a572d	2024-12-31	Warnings	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	Marketing end	Sample	Exclude flag	Status
70518-2813-0	70518281300	1 TUBE in 1 CARTON (70518-2813-0) > 100 g in 1 TUBE	1 tube	2020-07-13	0000-00-00	No	No	Current