Aleve

Product NDC: 0280-6080
11-digit product format: 002806080
Labeler code: 0280
Product ID: 0280-6080_4526c253-b571-1d84-e063-6394a90ae3f9
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA021920
Marketing category: NDA
Marketing start: 2007-02-20
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

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	0280-6080	0280-6080-03	D	Discontinued by firm		2026-08-10

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 · 12 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021920-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2006-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23
N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23
N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24
N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24
N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24
N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24
N021920-001	9693978	2026-03-03		Drug product	2017-11-13
N021920-001	9693979	2026-03-03		Drug product	2017-11-13

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 313 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`b8a1b40f171c…`

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
1112231	Internal RxNorm lookup
1112233	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
1266393e-b55e-4e34-9710-0b87209f4158	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	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
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0280-6080-01	Aleve	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	16
0280-6080-01	Aleve	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120	16
0280-6080-02	Aleve	2 in 1 PACKAGE, COMBINATION	CAPSULE, LIQUID FILLED	2	16
0280-6080-02	Aleve	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	16
0280-6080-03	Aleve	52 in 1 BOTTLE	CAPSULE, LIQUID FILLED	52	16
0280-6080-04	Aleve	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	16
0280-6080-04	Aleve	50 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	50	16
0280-6080-16	Aleve	160 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	160	16
0280-6080-20	Aleve	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	16
0280-6080-20	Aleve	20 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	20	16
0280-6080-40	Aleve	40 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	40	16
0280-6080-40	Aleve	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	16
0280-6080-80	Aleve	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	16
0280-6080-80	Aleve	80 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	80	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0280-6080-16	EA - Each	0280-6080	9635414a-5393-405a-818c-14d2a9fb9cc5	1	2024-04-05
0280-6080-20	EA - Each	0280-6080	f358a583-a9f8-4dc3-990b-09eeaf4305aa	1	2022-08-04
0280-6080-40	EA - Each	0280-6080	a8099631-abc3-46af-bcb1-70c65ed590f2	1	2018-04-19
0280-6080-80	EA - Each	0280-6080	f8cf155a-2987-4ba9-b6b8-b4d3332623b2	1	2022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Naproxen Sodium	ACTIVE INGREDIENT	9TN87S3A3C	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
Naproxen	ACTIVE MOIETY	57Y76R9ATQ	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
FD&C blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
povidone k30	INACTIVE INGREDIENT	U725QWY32X	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
sorbitan	INACTIVE INGREDIENT	6O92ICV9RU	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0280-6080	ALEVE (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]	15	Current NDC, Legacy NDC, 14 package rows	20231201_1266393e-b55e-4e34-9710-0b87209f4158.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	9343c79f-9994-4599-bcfe-0a93e49d726e	2026-05-12	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	04a298dc-c525-8198-e063-6294a90a6f96	2026-04-27	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	ba4f927a-4bbe-0d87-e053-2995a90a8c20	2026-04-20	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	MEIJER DISTRIBUTION INC	89f82399-9f71-49dd-8710-b60f346c576c	2025-12-12	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36bf8594-9303-c816-e063-6294a90af705	2025-12-08	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	1266393e-b55e-4e34-9710-0b87209f4158	2025-12-04	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 0280-6080
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3b5442c6-c6e1-4df3-8cec-40bbb4ec469f	2025-12-04	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Albertsons Companies	f9df7495-9da7-8838-e053-6294a90a6fda	2024-09-30	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	AMERISOURCE BERGEN	16b3bbee-4881-b439-e063-6394a90a7c8f	2024-04-22	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Bionpharma Inc.	3e10256f-0a5f-49e4-9518-a72b10490f89	2023-12-27	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	fed305f1-e32d-e1ff-e053-6294a90a273d	2023-10-03	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	a359c47e-e2b4-5560-e053-2a95a90a2844	2023-03-03	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	KROGER COMPANY	7487e685-ea64-43a2-9a4e-f5278840be04	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Wal-Mart Stores, Inc.	073ecef7-f5b1-4ee0-98bc-82972e3d84f9	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	a13bd208-f29f-1cbc-e053-2995a90a08ba	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	HEB	df8ea301-c48b-4da4-9e8e-5c69cac6cba7	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	TOP CARE (Topco Associates LLC)	c62b7fa0-5ae9-276c-e053-2995a90ade25	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION INC.	c482db41-b115-c24f-e053-2a95a90a2947	2022-12-21	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	462a7e41-b899-4e08-8113-b48ece0ad8d8	2022-03-17	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	DISCOUNT DRUG MART, INC.	b00c0e86-4c0b-45bf-948f-824ea0f09e39	2022-03-16	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920

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
1112233	Aleve 220 MG Oral Capsule	PSN	1266393e-b55e-4e34-9710-0b87209f4158	16
1112231	naproxen sodium 220 MG Oral Capsule	PSN	1266393e-b55e-4e34-9710-0b87209f4158	16
1112233	naproxen sodium 220 MG Oral Capsule [Aleve]	SBD	1266393e-b55e-4e34-9710-0b87209f4158	16
1112231	naproxen sodium 220 MG Oral Capsule	SCD	1266393e-b55e-4e34-9710-0b87209f4158	16
1112233	Aleve 220 MG (naproxen 200 MG) Oral Capsule	SY	1266393e-b55e-4e34-9710-0b87209f4158	16
1112233	Aleve 220 MG Oral Capsule	SY	1266393e-b55e-4e34-9710-0b87209f4158	16
1112231	naproxen sodium 220 MG (as naproxen 200 MG) Oral Capsule	SY	1266393e-b55e-4e34-9710-0b87209f4158	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0280-6080-01	00280608001	1 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2007-02-20	0000-00-00	No	No	Current
0280-6080-02	00280608002	2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE	2 bottle	2007-02-20	0000-00-00	No	No	Current
0280-6080-03	00280608003	52 CAPSULE, LIQUID FILLED in 1 BOTTLE (0280-6080-03)		2007-02-20	2021-06-29	No	No	Current
0280-6080-04	00280608004	1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-04) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC		2022-10-20	0000-00-00	No	No	Current
0280-6080-16	00280608016	160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16)		2007-02-20	0000-00-00	No	No	Current
0280-6080-20	00280608020	1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC		2007-02-20	0000-00-00	No	No	Current
0280-6080-40	00280608040	1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC		2007-02-20	0000-00-00	No	No	Current
0280-6080-80	00280608080	1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC		2007-02-20	0000-00-00	No	No	Current