Naproxen Sodium

Product NDC: 41250-680
11-digit product format: 412500680
Labeler code: 41250
Product ID: 41250-680_48070b27-da29-4f15-9865-fa1a0299ea0e
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA074661
Marketing category: ANDA
Marketing start: 2014-03-05
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: 2027-12-31
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	41250-680	41250-680-78	D	Discontinued by firm		2026-10-05

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 · 7 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…`

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
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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`84e616aacf4f…`
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…`

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: Naproxen Sodium
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849574	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
db87d1da-8507-4bbf-aefc-3dbd48cde26b	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41250-680-71	Naproxen Sodium	1 in 1 CARTON	TABLET, FILM COATED	1	8
41250-680-71	Naproxen Sodium	50 in 1 BOTTLE	TABLET, FILM COATED	50	8
41250-680-75	Naproxen Sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
41250-680-75	Naproxen Sodium	1 in 1 CARTON	TABLET, FILM COATED	1	8
41250-680-78	Naproxen Sodium	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
41250-680-78	Naproxen Sodium	1 in 1 CARTON	TABLET, FILM COATED	1	8

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-680	NAPROXEN SODIUM TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	7	Current NDC, Legacy NDC, 6 package rows	20250130_db87d1da-8507-4bbf-aefc-3dbd48cde26b.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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care naproxen sodium	NAPROXEN SODIUM	Safeway	85f78e63-98aa-4cf3-887d-0ac535184f97	2025-12-16	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
up and up naproxen sodium	NAPROXEN SODIUM	Target Corporation	b0e98603-94e9-474a-88a0-22042f461271	2025-11-19	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
up and up naproxen sodium	NAPROXEN SODIUM	Target Corporation	00bd8490-f280-4336-b13d-0e11c0bf4586	2025-11-04	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Rugby All Day Relief	NAPROXEN SODIUM	Rugby Laboratories	16e107f0-45a3-428f-b849-0f20a848a602	2025-10-30	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	b01c2b4e-a092-42dc-a387-d181d8ba14bb	2025-10-30	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
foster and thrive all day pain relief	NAPROXEN SODIUM	Strategic Sourcing Services LLC	01746bb6-4068-4737-ba38-04cd5f1a81ba	2025-09-12	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e5e8768d-c6e0-4018-b788-5ce86929f7b0	2025-08-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
NAPROXEN SODIUM	NAPROXEN SODIUM	Safeway	396f4e60-3dde-433f-b4b5-25f351c96d57	2025-08-19	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
TopCare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	079eccdd-33bd-4b5c-bf46-9aef78559082	2025-07-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
kirkland signature naproxen sodium	NAPROXEN SODIUM	Costco Wholesale Company	d63cd2ad-18cf-4379-b48e-a487334ad9cc	2025-07-16	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
equaline naproxen sodium	NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	1022d075-9bdf-46df-81ac-c84cb2608195	2025-06-04	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	Meijer Distribution Inc	72f461bc-621e-4e2b-b437-53a580125f3c	2025-05-02	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
basic care naproxen sodium	NAPROXEN SODIUM	Amazon.com Services LLC	29fc5a16-49ed-41ca-a296-bee34d1d12f6	2025-04-17	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	3d57ba5c-3a1d-435a-aa4f-9cc709e1b8cf	2025-03-28	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
rugby all day relief	NAPROXEN SODIUM	A-S Medication Solutions	369f5123-283d-4aa6-8861-8d183f2ba94d	2025-03-18	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Care One Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	88812af7-89ca-449b-9513-20c284543d0e	2025-03-13	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
CareOne Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	0ac4c343-a5b6-4f69-a75a-87074dc867e8	2025-03-04	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	9551e84b-19bc-43e7-9c6e-0f24fdeb5abe	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
All Day Relief	NAPROXEN SODIUM	Publix Super Markets Inc	688451a2-e94a-434a-8e9c-9fe3abf5c3d5	2025-02-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
DG Health Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp Inc	534eaf8a-0d2a-4390-af92-af5c98ba56a5	2025-01-23	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	db87d1da-8507-4bbf-aefc-3dbd48cde26b	8
849574	naproxen sodium 220 MG Oral Tablet	SCD	db87d1da-8507-4bbf-aefc-3dbd48cde26b	8
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	db87d1da-8507-4bbf-aefc-3dbd48cde26b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-680-71	41250068071	1 BOTTLE in 1 CARTON (41250-680-71) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2014-03-05	0000-00-00	No	No	Current
41250-680-75	41250068075	1 BOTTLE in 1 CARTON (41250-680-75) / 90 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-02-14	0000-00-00	No	No	Current
41250-680-78	41250068078	1 BOTTLE in 1 CARTON (41250-680-78) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2014-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Naproxen Sodium Tablets, 220 mg Drug Facts	Meijer Distribution Inc	2026-02-05	HUMAN OTC DRUG LABEL	8