Naproxen Sodium

Product NDC: 51316-608
Requested package NDC: 51316-608-90
11-digit product format: 513160608
Labeler code: 51316
Product ID: 51316-608_3c14f8af-cefb-ec0f-e063-6394a90a2caa
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen sodium 220mg
Dosage form: TABLET
Route: ORAL
Labeler: CVS Pharmacy, Inc.
Application: ANDA090545
Marketing category: ANDA
Marketing start: 2025-05-01
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
A090545-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-03-16

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	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090545-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090545-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium 220mg	NAPROXEN SODIUM 220MG	Grocery Outlet	1f5b5c55-44df-4872-8c74-b8a812efc32a	2026-03-18	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
BACK AND MUSCLE PAIN	NAPROXEN	WALGREENS	81417810-8a34-c859-e053-2a91aa0a6507	2026-01-26	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
CALMADOL PAIN RELIEVER	NAPROXEN SODIUM	GRANDALL DISTRIBUTING, LLC	8edec8d1-a323-436b-8329-c327438516e3	2025-10-28	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium	NAPROXEN SODIUM 220MG	CVS Pharmacy, Inc.	1fde52e7-7a7f-40e8-e063-6394a90a922a	2025-08-11	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545 ndc (package): 51316-608-90 ndc (product): 51316-608 ndc11 (package): 51316060890
All Day Pain Relief	NAPROXEN SODIUM	Walmart Inc.	32df7378-4dd1-4f7e-e063-6394a90ad948	2025-05-09	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Belmora Flanax	NAPROXEN SODIUM	Belmora LLC	a44b8a82-251d-d5e8-e053-2a95a90a72f7	2024-10-08	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
ALL DAY PAIN RELIEF	NAPROXEN SODIUM	WALGREENS	8771b84f-47bf-116c-e053-2995a90a0aad	2024-03-15	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
ALL DAY PAIN RELIEF	NAPROXEN SODIUM	WALGREENS	8771300f-e907-3d53-e053-2a95a90ae402	2024-03-15	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
All Day Back and Muscle Pain Relief	NAPROXEN SODIUM	Walmart Inc.	062b9ffe-b4fc-9f5a-e063-6294a90a560e	2023-12-04	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
NAPROXEN SODIUM	NAPROXEN SODIUM	TIME CAP LABORATORIES, INC	ab7b7b8e-923b-4dc1-812c-78e85de1bee1	2023-09-13	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Pain Relief	NAPROXEN SODIUM	BETTER LIVING BRANDS, LLC	eb604ea6-f5c1-156b-e053-2a95a90a76d7	2023-06-13	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium	NAPROXEN SODIUM	BETTER LIVING BRANDS LLC.	f2c06861-0322-93ed-e053-2995a90a5902	2023-06-13	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium	NAPROXEN SODIUM, COATED TABLETS	MARKSANS PHARMA LIMITED	48cb1363-ff12-40ee-a87a-2252dfbf8ff7	2023-06-09	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Flanax Pain Reliever/Fever Reducer	NAPROXEN SODIUM	Navajo Manufacturing Company Inc.	f706b406-58f2-9b82-e053-6394a90ab598	2023-03-16	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
NAPROXEN SODIUM	NAPROXEN SODIUM	TIME CAP LABORATORIES, INC	17ecaee0-c1c6-4360-81c1-d6afe50b9b27	2021-12-01	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
NAPROXEN SODIUM	NAPROXEN SODIUM	Kroger Company	bc185bf2-bc2c-f439-e053-2995a90a93d0	2021-06-03	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium 220mg	NAPROXEN SODIUM 220MG	Allegiant Health	14554f05-14e1-4c52-99ce-94561c42c0da	2021-04-21	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Flanax Pain Reliever/Fever reducer	NAPROXEN SODIUM	Belmora LLC	05337e0b-8baf-42d6-a642-3052f77ed304	2020-05-29	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Caplets	NAPROXEN SODIUM 220 MG	Allegiant Health	07120764-7c33-4c07-9367-40956d970c60	2019-06-06	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium 220mg	NAPROXEN SODIUM 220MG	Command Brands, LLC	002052df-83ac-4efd-926c-b60a8f64cec4	2018-12-14	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545

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
1fde52e7-7a7f-40e8-e063-6394a90a922a	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	Strength	SPL version
51316-608-90	Naproxen Sodium	90 in 1 BOTTLE	TABLET	90		3

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	1fde52e7-7a7f-40e8-e063-6394a90a922a	3
849574	naproxen sodium 220 MG Oral Tablet	SCD	1fde52e7-7a7f-40e8-e063-6394a90a922a	3
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	1fde52e7-7a7f-40e8-e063-6394a90a922a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-608-90	51316060890	90 TABLET in 1 BOTTLE (51316-608-90)	90 tablet	2025-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
608R_CVS_Naproxen Sodium 220mg film coated Tablets	CVS Pharmacy, Inc. \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LTD	2025-08-11	HUMAN OTC DRUG LABEL	3