DICLOFENAC SODIUM

Product NDC: 62379-401
11-digit product format: 623790401
Labeler code: 62379
Product ID: 62379-401_14062028-4023-9b1c-e063-6394a90a1f53
Type: HUMAN OTC DRUG
Nonproprietary name: diclofenac sodium topical gel, 1%
Dosage form: GEL
Route: TOPICAL
Labeler: Simple Diagnostics
Application: ANDA210986
Marketing category: ANDA
Marketing start: 2024-03-13
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: 2026-12-31
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	10 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
855633	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
13925cd5-e121-80d2-e063-6394a90af9a9	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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	SPL version
62379-401-01	DICLOFENAC SODIUM	100 g in 1 TUBE	GEL	100	8
62379-401-02	DICLOFENAC SODIUM	1 in 1 CARTON	GEL	1	8
62379-401-03	DICLOFENAC SODIUM	150 g in 1 TUBE	GEL	150	8
62379-401-04	DICLOFENAC SODIUM	1 in 1 CARTON	GEL	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62379-401-01	GM - Gram	62379-401	ef674c44-7b6c-4b43-ab1a-aaba35743bfc	1	2024-04-05
62379-401-03	GM - Gram	62379-401	23876cdc-9b0b-492d-bf77-51c1b60e6bfc	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62379-401	DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%) GEL [SIMPLE DIAGNOSTICS]	8	Current NDC, 4 package rows	20240321_13925cd5-e121-80d2-e063-6394a90af9a9.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 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 ndc (product): 62379-401
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855633	diclofenac sodium 1 % Topical Gel	PSN	13925cd5-e121-80d2-e063-6394a90af9a9	8
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	13925cd5-e121-80d2-e063-6394a90af9a9	8
855633	diclofenac sodium 1 % Topical Gel	SY	13925cd5-e121-80d2-e063-6394a90af9a9	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62379-401-01	62379040101	100 g in 1 TUBE	100 g				Historical
62379-401-02	62379040102	1 TUBE in 1 CARTON (62379-401-02) / 100 g in 1 TUBE (62379-401-01)	1 tube	2024-03-13	No	No	Current
62379-401-03	62379040103	150 g in 1 TUBE	150 g				Historical
62379-401-04	62379040104	1 TUBE in 1 CARTON (62379-401-04) / 150 g in 1 TUBE (62379-401-03)	1 tube	2024-03-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever	Simple Diagnostics	2024-03-19	HUMAN OTC DRUG LABEL	8