Naproxen Sodium

Product NDC: 67091-140
11-digit product format: 670910140
Labeler code: 67091
Product ID: 67091-140_289ba9d7-2846-5bdc-e063-6394a90af81c
Type: HUMAN OTC DRUG
Nonproprietary name: NAPROXEN SODIUM
Dosage form: TABLET, COATED
Route: ORAL
Labeler: WinCo Foods, LLC
Application: ANDA079096
Marketing category: ANDA
Marketing start: 2014-12-15
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

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
A079096-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2008-12-16

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	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079096-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2008-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079096-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2008-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen Sodium
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 · 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
074fc2b9-743b-458e-a0c0-d5f27633bbf3	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67091-140-10	Naproxen Sodium	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	3
67091-140-10	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	3
67091-140-50	Naproxen Sodium	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	3
67091-140-50	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-140	NAPROXEN SODIUM TABLET, COATED [WINCO FOODS, LLC]	3	Current NDC, Legacy NDC, 4 package rows	20241208_074fc2b9-743b-458e-a0c0-d5f27633bbf3.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 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Mediproxen	NAPROXEN SODIUM	Sportpharm LLC	f01adfcc-b32a-4a98-a4e7-2ce87b824b5a	2026-04-24	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a0c910-7dd7-6a42-e063-6394a90a491c	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a00020-173b-a4a1-e063-6294a90ae399	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	12748345-0d79-d6f8-e063-6394a90ab6c6	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	1274889d-803c-d7fd-e063-6394a90ab9a8	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	d9e72c3f-addc-4391-a7a4-2680a3e7f5c4	2025-12-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	2ee83008-c012-48d6-9479-65e7d6f50f4c	2025-12-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	27938b08-ff37-4587-aa81-5ec3ef21a28a	2025-12-09	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
CAREALL Naproxen	NAPROXEN SODIUM	New World Imports, Inc.	d9a0c6e7-a70e-479a-9737-e81a2887c778	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
CAREALL Naproxen Sodium	NAPROXEN SODIUM	New World Imports, Inc.	3952324e-77f4-4117-a97a-ab5651130058	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique at Home Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	b591ba4f-d7d3-4c81-e053-2995a90a7c6e	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	f6261d45-df1f-483b-b013-3cd6f78d9d43	2025-09-08	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	AMERIFOODS TRADING COMPANY	f6dd2150-1643-18ff-e053-6294a90a422b	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	684e03b6-74eb-4374-a512-1c01ea216b51	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	eeda0edf-7054-42aa-af8e-4df38b918f81	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	84b9e9a4-b805-420e-83be-ebe98776d1ee	2025-06-20	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
NAPROXEN SODIUM	NAPROXEN SODIUM	AAA Pharmaceutical, Inc.	5ea3217d-845d-4781-b849-6b00babdc214	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	FSA STORE INC.	f4326f99-142b-0b70-e053-2995a90ac951	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	38543976-ccbe-4af9-b01d-ae102452d418	2025-05-21	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	04245a78-228e-439f-8ffb-9d9bc56c7bb7	2025-05-20	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096

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	074fc2b9-743b-458e-a0c0-d5f27633bbf3	3
849574	naproxen sodium 220 MG Oral Tablet	SCD	074fc2b9-743b-458e-a0c0-d5f27633bbf3	3
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	074fc2b9-743b-458e-a0c0-d5f27633bbf3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-140-10	67091014010	1 BOTTLE, PLASTIC in 1 CARTON (67091-140-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-12-15	0000-00-00	No	No	Current
67091-140-50	67091014050	1 BOTTLE, PLASTIC in 1 CARTON (67091-140-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-12-15	0000-00-00	No	No	Current