Aleve

Product NDC: 29485-7534
Requested package NDC: 29485-7534-3
11-digit product format: 294857534
Labeler code: 29485
Product ID: 29485-7534_e660ddcd-1c51-ebb7-e053-2995a90a4c64
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen sodium tablet
Dosage form: TABLET
Route: ORAL
Labeler: Mechanical Servants LLC
Application: NDA020204
Marketing category: NDA
Marketing start: 2016-11-01
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29485-7534	29485-7534-3	D	Discontinued by firm		2026-10-05

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
N020204-002	ALEVE	NAPROXEN SODIUM	220MG	TABLET / ORAL		RLD, RS	1994-01-11

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020204-002	ALEVE	EQ 200MG BASE	TABLET / ORAL	RLD, RS	1994-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020204-002	ALEVE	EQ 200MG BASE	TABLET / ORAL	RLD, RS	1994-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-7534	ALEVE (NAPROXEN SODIUM TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.]	9	Legacy NDC	20231207_d17b017a-627c-20de-e053-2a95a90a21a0.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aleve Caplets	NAPROXEN SODIUM	Select Consumer Group	3ca84972-f8c9-1881-e063-6294a90a9070	2026-07-03	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve	NAPROXEN SODIUM	Navajo Manufacturing Company Inc.	590f3be2-20df-4643-9114-e7ed4cf9155c	2026-04-08	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Caplets	NAPROXEN SODIUM	Bayer HealthCare LLC.	02941928-128a-2c88-e063-6294a90ac6ba	2026-03-12	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC	c69f4926-c5cd-63a0-e053-2a95a90a2ca6	2025-12-04	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	00ef5b30-71d0-4cb4-84a3-48c67d1cea2a	2025-12-04		Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Back and Muscle Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	6376e1b8-52c4-0519-e053-2a91aa0af35f	2025-12-04		Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Caplets	NAPROXEN SODIUM	Bayer HealthCare LLC.	a3745850-3e32-4884-b315-161bcb9996ed	2025-12-04		Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Gelcaps	NAPROXEN SODIUM	Bayer HealthCare LLC.	acea54a2-5a92-428e-a778-bb4f9d676782	2025-12-04		Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Gelcaps	NAPROXEN SODIUM	Bayer HealthCare LLC.	0ad8bbb9-dd5f-4273-b085-ee3e5ed22613	2025-12-04	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3c0ddd25-5a9a-4628-a971-65fe2a9775b5	2025-12-04	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve	NAPROXEN SODIUM	R J General Corporation	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	2025-11-17	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Bayer Aleve	NAPROXEN SODIUM	Unifirst First Aid Corporation	5dd569ca-d03e-410c-af98-4732c823d595	2025-09-09	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	3ba28e47-1294-bec7-e063-6294a90ac80a	2025-08-05	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Caplets - Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	94f09ef7-0695-4499-83c1-95f1e42baf98	2025-04-10	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	31bad2d9-c0bb-7f20-e063-6294a90acb17	2025-04-01	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Back and Muscle Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	31bae77b-42dd-94eb-e063-6294a90ad570	2025-04-01	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve Headache Pain	NAPROXEN SODIUM	Bayer HealthCare LLC.	31baf777-c805-21ea-e063-6394a90abbd8	2025-04-01	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve	NAPROXEN SODIUM	Lil' Drug Store Products, Inc	abfcf13e-6eba-49e2-8ebf-459348714270	2025-01-06	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Bayer Aleve	NAPROXEN SODIUM	Acme United Corporation	f758201c-28b8-5357-e053-6394a90a1e5d	2023-03-20	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204
Aleve	NAPROXEN SODIUM	Navajo Manufacturing Company Inc	60637aeb-deb6-4747-e053-2a91aa0ad00b	2023-03-01	Warnings	Exact identifier application applno (NDA): 020204 application number: NDA020204

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29485-7534-3	29485753403	30 POUCH in 1 BOX (29485-7534-3) > 1 TABLET in 1 POUCH	30 pouch	2016-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALEVE CAPLETS naproxen sodium tablet	Lil' Drug Store Products, Inc.	2023-12-05	HUMAN OTC DRUG LABEL	9