Aleve Arthritis Pain Gel

Product NDC: 0280-0039
11-digit product format: 002800039
Labeler code: 0280
Product ID: 0280-0039_452615d3-7d62-4fa6-e063-6394a90a5dfd
Type: HUMAN OTC DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Bayer HealthCare LLC
Application: ANDA211253
Marketing category: ANDA
Marketing start: 2021-06-01
Substance: DICLOFENAC SODIUM
Active strength: 1 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 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
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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`cb3db0bc1861…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aleve Arthritis Pain Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	1 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855633	Internal RxNorm lookup
2550740	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
bad675d1-1204-0136-e053-2995a90a994e	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
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
0280-0039-01	Aleve Arthritis Pain Gel	1 in 1 CARTON	GEL	1	5
0280-0039-01	Aleve Arthritis Pain Gel	100 g in 1 TUBE	GEL	100	5
0280-0039-02	Aleve Arthritis Pain Gel	1 in 1 CARTON	GEL	1	5
0280-0039-02	Aleve Arthritis Pain Gel	50 g in 1 TUBE	GEL	50	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0280-0039	ALEVE ARTHRITIS PAIN GEL (DICLOFENAC SODIUM) GEL [BAYER HEALTHCARE LLC]	4	Current NDC, Legacy NDC, 4 package rows	20231201_bad675d1-1204-0136-e053-2995a90a994e.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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARTHRITIS PAIN RELIEF	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	84978746-4ab5-456d-af63-5c86ab0a05f5	2026-06-29	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
arthritis pain reliever	DICLOFENAC SODIUM	HyVee Inc	bc74d53d-4142-4391-935b-61b7e353bd65	2026-04-30	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
TOPCARE ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Topco Associates LLC	1d6c4c38-3739-4d58-9811-bac09fcbfadb	2026-04-24	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
EQUATE ARTHRITIS PAIN	DICLOFENAC SODIUM	WALMART INC.	d05b5f82-8772-4e01-8eb3-6fa6042f5661	2026-04-20	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
arthritis pain relieving	DICLOFENAC SODIUM	Walgreen Company	0da5d1d0-d8a4-4509-a098-e9c36d282474	2026-03-31	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Publix Super Markets Inc	bae07276-c800-468e-a201-e6268846fff3	2026-01-15	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
DICLOFENAC SODIUM TOPICAL	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	2026-01-15	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
UP AND UP ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Target Corporation	3a9b32af-a3cd-496b-9698-0421443e0385	2025-12-08	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
Aleve Arthritis Pain Gel	DICLOFENAC SODIUM	Bayer HealthCare LLC	bad675d1-1204-0136-e053-2995a90a994e	2025-12-04	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253 ndc (product): 0280-0039
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	H E B	027803c5-85ae-4b86-8bd4-e61f8f34d036	2025-11-17	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
ARTHRITIS PAIN RELIEVING	DICLOFENAC SODIUM	Meijer, Inc.	5cc570c6-2585-4d1a-9352-b1161458af9a	2025-11-17	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
GOOD SENSE ARTHRITIS PAIN	DICLOFENAC SODIUM	L. Perrigo Company	6e45a111-f6be-4c64-a2d2-7ac51a2ea6a1	2025-11-07	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
ARTHRITIS PAIN RELIEVING	DICLOFENAC SODIUM	Walgreen Company	b1850a16-54f1-4210-abdf-26414da8b3d9	2025-09-29	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
FOSTER AND THRIVE ARTHRITIS PAIN	DICLOFENAC SODIUM	Strategic Sourcing Services LLC	f9f4e55f-ffad-4df7-9b3c-1e7c3a3723c1	2025-09-27	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
DG HEALTH ARTHRITIS PAIN	DICLOFENAC SODIUM	Dolgencorp Inc	6479e4bb-0790-483e-bfe3-a54d549aa5d2	2025-09-15	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
MEMBERS MARK ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Sam's West Inc	d339aaa2-ae7e-4a79-b687-cf0a3106fad0	2025-07-16	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
kirkland signature arthritis pain relief	DICLOFENAC SODIUM	Costco Wholesale Company	c30353da-acd6-474f-8a64-abd078bf4f85	2025-06-11	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
members mark arthritis pain reliever	DICLOFENAC SODIUM	Sam's West Inc	44533b5b-73ce-4853-9eda-506426cb9b82	2025-06-09	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
up and up arthritis pain reliever	DICLOFENAC SODIUM	Target Corporation	0b7ae58c-cdaf-4343-a199-7a90bf901eb5	2025-04-27	Warnings	Exact identifier application applno (ANDA): 211253 application number: ANDA211253
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	762b7ef4-166c-43b8-9acd-2b9e7fa0bf36	2025-01-28	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
2550740	Aleve Arthritis Pain 1 % Topical Gel	PSN	bad675d1-1204-0136-e053-2995a90a994e	5
855633	diclofenac sodium 1 % Topical Gel	PSN	bad675d1-1204-0136-e053-2995a90a994e	5
2550740	diclofenac sodium 0.01 MG/MG Topical Gel [Aleve Arthritis Pain]	SBD	bad675d1-1204-0136-e053-2995a90a994e	5
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	bad675d1-1204-0136-e053-2995a90a994e	5
2550740	Aleve Arthritis Pain 0.01 MG/MG Topical Gel	SY	bad675d1-1204-0136-e053-2995a90a994e	5
2550740	Aleve Arthritis Pain 1 % Topical Gel	SY	bad675d1-1204-0136-e053-2995a90a994e	5
855633	diclofenac sodium 1 % Topical Gel	SY	bad675d1-1204-0136-e053-2995a90a994e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0280-0039-01	00280003901	1 TUBE in 1 CARTON (0280-0039-01) / 100 g in 1 TUBE	1 tube	2021-06-01	0000-00-00	No	No	Current
0280-0039-02	00280003902	1 TUBE in 1 CARTON (0280-0039-02) / 50 g in 1 TUBE	1 tube	2021-06-01	0000-00-00	No	No	Current