naproxen sodium

Product NDC: 11822-0490
11-digit product format: 118220490
Labeler code: 11822
Product ID: 11822-0490_1d3cd8bf-240a-4214-8856-97be8d37bf42
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA074661
Marketing category: ANDA
Marketing start: 2001-05-16
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	11822-0490		D	Discontinued by firm	2026-08-03
excluded package	package	11822-0490	11822-0490-1	D	Discontinued by firm	2026-08-03
excluded package	package	11822-0490	11822-0490-5	D	Discontinued by firm	2026-08-03
excluded package	package	11822-0490	11822-0490-7	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 5 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11822-0490	11822-0490-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11822-0490	11822-0490-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11822-0490	11822-0490-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11822-0490	11822-0490-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11822-0490	11822-0490-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
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
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [RITE AID CORPORATION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0490	NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION]	7	Legacy NDC	20220126_1b63177f-17e5-4b5a-8924-7023efe016aa.zip

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
11822-0490-1	11822049001	1 BOTTLE in 1 CARTON (11822-0490-1) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2001-05-22	0000-00-00	No	No	Current
11822-0490-5	11822049005	1 BOTTLE in 1 CARTON (11822-0490-5) > 90 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-12-29	0000-00-00	No	No	Current
11822-0490-7	11822049007	1 BOTTLE in 1 CARTON (11822-0490-7) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2001-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Corporation Naproxen Sodium Tablets, 220 mg Drug Facts	Rite Aid Corporation	2021-12-29	HUMAN OTC DRUG LABEL	7