Aleve

Product NDC: 70264-011
Requested package NDC: 70264-011-01
11-digit product format: 702640011
Labeler code: 70264
Product ID: 70264-011_43c866a6-dc20-5e19-e063-6294a90aac20
Type: HUMAN OTC DRUG
Nonproprietary name: NAPROXEN SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: R J General Corporation
Application: NDA020204
Marketing category: NDA
Marketing start: 2014-02-26
Substance: NAPROXEN SODIUM
Active strength: 220 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: 2026-12-31
Current FDA listing: Yes

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849574	Internal RxNorm lookup
849728	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
46e7b298-9e19-49b6-be71-e4fdcb09a5d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70264-011-01	2022-09-21	C162847	48780-1	9d75b9d0-3679-f424-e053-dadaa90a57ce	Aleve ®
70264-011-01	2020-01-31	C162847	48780-1	9d75b9d0-3679-f424-e053-dadaa90a57ce	Aleve ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70264-011-01	Aleve	50 in 1 CARTON	TABLET	50		8
70264-011-01	Aleve	1 in 1 POUCH	TABLET	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70264-011	ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION]	7	Current NDC, Legacy NDC, 2 package rows	20241112_46e7b298-9e19-49b6-be71-e4fdcb09a5d4.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 ndc (package): 70264-011-01 ndc (product): 70264-011 ndc11 (package): 70264001101
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849728	Aleve 220 MG Oral Tablet	PSN	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	8
849574	naproxen sodium 220 MG Oral Tablet	PSN	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	8
849728	naproxen sodium 220 MG Oral Tablet [Aleve]	SBD	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	8
849574	naproxen sodium 220 MG Oral Tablet	SCD	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	8
849728	Aleve 220 MG Oral Tablet	SY	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	8
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	46e7b298-9e19-49b6-be71-e4fdcb09a5d4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70264-011-01	70264001101	50 POUCH in 1 CARTON (70264-011-01) / 1 TABLET in 1 POUCH	50 pouch	2014-02-26	0000-00-00	No	No	Current