pain relief

Product NDC: 0363-0140
11-digit product format: 003630140
Labeler code: 0363
Product ID: 0363-0140_fc3ff125-b7a0-4cd2-aed8-e0dfb6ca5f0b
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Walgreen Company
Application: ANDA074661
Marketing category: ANDA
Marketing start: 2011-10-22
Marketing end: 0000-00-00
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0363-0140		D	Discontinued by firm	2026-08-17
excluded package	package	0363-0140	0363-0140-75	D	Discontinued by firm	2026-08-17
excluded package	package	0363-0140	0363-0140-78	D	Discontinued by firm	2026-08-17
excluded package	package	0363-0140	0363-0140-82	D	Discontinued by firm	2026-08-17

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0140-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0140-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-0140-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0140-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0140-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-0140-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-0140-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-0140-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-0140-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-0140-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-0140-82	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-0140-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-0140-82	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-0140-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0140-82	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0140-78	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0140-82	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0140-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0140-82	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0140-78	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-0140-82	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-0140-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-0140-82	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-0140-78	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-0140-82	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-0140-78	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074661-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1997-01-13

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0140-78	EA - Each	0363-0140	65fdb98a-cc12-4de6-be56-86cb49be2955	1	2022-06-06
0363-0140-82	EA - Each	0363-0140	b654ff2b-cdf6-4e51-8cf1-160a363fb7f5	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0140	PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [WALGREEN COMPANY]	9	Legacy NDC	20250327_e8f3d7e8-cd29-4536-86b7-44c3d5f08ba6.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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals Inc.	2183df53-ac90-4d43-8a5d-8421036bc4cb	2026-07-28	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	d2b1eedb-2be0-42af-ba0b-9da98560c91e	2026-07-24	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	b5dcf3df-2628-49c7-9d96-64886bebe631	2026-07-13	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5146d73-2f34-4dfe-ac29-97071279dc4d	2026-05-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Berkley and Jensen Naproxen Sodium	NAPROXEN SODIUM	BJWC	9530b649-3e01-452c-99a6-cff47fa4085b	2026-05-21	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	8e150c00-8e5b-40b4-a964-cb70442c2752	2026-05-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
equaline naproxen sodium	NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	89c02e55-fa08-4001-96fc-8a01e7e74d5a	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
all day relief	NAPROXEN SODIUM	Publix Super Markets Inc	0f8843be-50a3-442c-9016-d9da3b444f60	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
rugby all day relief	NAPROXEN SODIUM	Rugby Laboratories	f587a428-291c-4c54-80fe-244a961b0521	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	efe4352f-856b-4ada-8bd4-0a78423447dc	2026-02-27	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Topcare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	7f1cda40-9a67-4de1-af56-ab881c6354c4	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	2f9439bb-e808-4c54-ba61-f75f117c8b37	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Padagis Israel Pharmaceuticals Ltd	cdb60f74-ce23-4015-90eb-b23a2275f6cb	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
topcare back and muscle pain	NAPROXEN SODIUM	Topco Associates LLC	de587e8f-38f2-4e7a-8e6a-64e48f280c4f	2026-02-07	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	db87d1da-8507-4bbf-aefc-3dbd48cde26b	2026-02-05	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Rugby All Day Relief	NAPROXEN SODIUM	Bryant Ranch Prepack	3238dfdc-82d1-4afb-b27c-0ba0a5d24744	2026-02-04	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	6bc74cda-458c-480e-a33c-d2ba68d5e6bd	2026-01-29	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Care One Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	bc5ddcf2-640c-4683-a60f-ca1c8b418873	2026-01-29	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	dbf007f5-c792-43a7-8cc1-bfa617f3a7fa	2026-01-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	Meijer Distribution Inc	f4e57560-ae89-4fc3-a66b-ebf3dc3f2448	2026-01-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0140-75	00363014075	90 TABLET, FILM COATED in 1 BOTTLE (0363-0140-75)	2022-04-13	0000-00-00	No	No	Current
0363-0140-78	00363014078	100 TABLET, FILM COATED in 1 BOTTLE (0363-0140-78)	2016-07-07	0000-00-00	No	No	Current
0363-0140-82	00363014082	200 TABLET, FILM COATED in 1 BOTTLE (0363-0140-82)	2011-10-22	0000-00-00	No	No	Current