DICLOFENAC SODIUM TOPICAL

Product NDC: 51316-804
11-digit product format: 513160804
Labeler code: 51316
Product ID: 51316-804_caa8dc8f-4b10-4098-957d-c9ab06dfec03
Type: HUMAN OTC DRUG
Nonproprietary name: DICLOFENAC SODIUM
Dosage form: GEL
Route: TOPICAL
Labeler: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application: ANDA211253
Marketing category: ANDA
Marketing start: 2025-05-13
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: 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
A211253-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2019-05-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211253-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211253-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211253-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211253-001	AB	1	`ea99ee380514…`

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 TOPICAL
Listing expiration: 2027-12-31

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
181e32ab-5ec0-4be4-bad0-b6bbafc08f85	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
51316-804-01	DICLOFENAC SODIUM TOPICAL	1 in 1 CARTON	GEL	1	3
51316-804-01	DICLOFENAC SODIUM TOPICAL	100 g in 1 TUBE	GEL	100	3
51316-804-02	DICLOFENAC SODIUM TOPICAL	50 g in 1 TUBE	GEL	50	3
51316-804-02	DICLOFENAC SODIUM TOPICAL	1 in 1 CARTON	GEL	1	3
51316-804-03	DICLOFENAC SODIUM TOPICAL	150 g in 1 TUBE	GEL	150	3
51316-804-03	DICLOFENAC SODIUM TOPICAL	1 in 1 CARTON	GEL	1	3

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 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MOTRIN ARTHRITIS PAIN	DICLOFENAC SODIUM	Kenvue Brands LLC	db5b4288-13ec-826b-e053-2995a90a275e	2024-11-08	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
kirkland signature arthritis pain relief	DICLOFENAC SODIUM	Costco Wholesale Company	8e53e5fa-fda2-4e3a-8c5a-82435e3d51c3	2024-11-01	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
good sense arthritis pain	DICLOFENAC SODIUM	A-S Medication Solutions	5f1ca9c1-c7fe-4a91-af5e-dc22b175f083	2024-09-26	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	20ef08a3-35cf-b4d6-e063-6394a90a012e	2024-08-30	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	005299ac-b6de-511f-e063-6294a90a29e0	2024-07-29	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
Diclofenac Sodium	DICLOFENAC SODIUM	Padagis Israel Pharmaceuticals Ltd	17bd62a8-b697-48cc-b988-aac3c19c6dc5	2024-01-22	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
Diclofenac Sodium	DICLOFENAC SODIUM	CVS Pharmacy	e9ccaf95-582b-4d4d-938f-7577eaa8dffb	2023-11-27	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
equaline arthritis pain relieving	DICLOFENAC SODIUM	United Natural Foods, Inc. dba UNFI	748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d0	2023-08-23	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
equate arthritis pain	DICLOFENAC SODIUM	Wal-Mart Stores Inc	5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b	2023-07-27	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
berkley and jensen arthritis pain	DICLOFENAC SODIUM	BJWC	441cf367-b293-47e8-a8fb-32e3314be7de	2023-07-26	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
CareOne arthritis pain relief	DICLOFENAC SODIUM	American Sales Company	69615972-b593-44fb-ae49-9441d872d84a	2023-06-08	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
DG health arthritis pain	DICLOFENAC SODIUM	Dolgencorp Inc	e7f93d8f-df2b-4005-b58d-c6f10ae0e0f3	2023-05-24	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
arthritis pain reliever	DICLOFENAC SODIUM	Publix Super Markets Inc	445de976-9a28-4e97-929f-c77aeb21c1fa	2023-05-15	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
arthritis pain relieving	DICLOFENAC SODIUM	Meijer Distribution Inc	d46a4841-2f86-4e0e-ac79-9b1444ed4f79	2023-05-15	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
topcare athritis pain reliever	DICLOFENAC SODIUM	Topco Associates LLC	d3e9416d-e13b-4cc7-a663-6df3534b8dbe	2023-05-10	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
good sense arthritis pain	DICLOFENAC SODIUM	L. Perrigo Company	7b32b9e4-6502-4fa3-808f-3bef9525b6a1	2023-05-10	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
arthritis pain reliever	DICLOFENAC SODIUM	H E B	e8fe4a89-586d-461c-b242-b68e38a508b4	2023-03-09	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
Diclofenac Sodium	DICLOFENAC SODIUM	Rite Aid Corporation	1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f	2022-08-23	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
good sense arthritis pain	DICLOFENAC SODIUM	Proficient Rx LP	67eacd91-8378-47e7-9bad-1e7b685aa9d4	2022-06-01	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
basic care arthritis pain	DICLOFENAC SODIUM	Amazon.com Services LLC	a8aa9016-bf2d-4727-9184-512b2570000b	2022-01-06	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253

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	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	3
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	3
855633	diclofenac sodium 1 % Topical Gel	SY	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-804-01	51316080401	1 TUBE in 1 CARTON (51316-804-01) / 100 g in 1 TUBE	1 tube	2025-10-14	No	No	Current
51316-804-02	51316080402	1 TUBE in 1 CARTON (51316-804-02) / 50 g in 1 TUBE	1 tube	2025-09-08	No	No	Current
51316-804-03	51316080403	1 TUBE in 1 CARTON (51316-804-03) / 150 g in 1 TUBE	1 tube	2025-05-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Diclofenac Sodium Topical Gel, 1% (NSAID) Drug Facts	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	2026-01-15	HUMAN OTC DRUG LABEL	3