Naproxen Sodium 220mg

Product NDC: 53185-362
Requested package NDC: 53185-362-50
11-digit product format: 531850362
Labeler code: 53185
Product ID: 53185-362_15a4708b-ad90-4051-9b5d-976f70658931
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium 220mg
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Athlete's Needs, Inc.
Application: ANDA090545
Marketing category: ANDA
Marketing start: 2014-12-23
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 220 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53185-362	53185-362-50	I	Inactivated by FDA		2026-08-07

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53185-362-50	2025-01-30	C162847	48780-1	2cef2736-6a58-d83d-e063-dadaa90ab31f	Naproxen Sodium 220mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53185-362-50	Naproxen Sodium 220mg	50 in 1 BOTTLE	TABLET, COATED	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53185-362	NAPROXEN SODIUM 220MG TABLET, COATED [ATHLETE'S NEEDS, INC.]	4	Legacy NDC, 1 package rows	20210422_91e1fef2-0e9b-4553-92f2-ddf219990695.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 · 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
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

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	91e1fef2-0e9b-4553-92f2-ddf219990695	4
849574	naproxen sodium 220 MG Oral Tablet	SCD	91e1fef2-0e9b-4553-92f2-ddf219990695	4
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	91e1fef2-0e9b-4553-92f2-ddf219990695	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53185-362-50	53185036250	50 TABLET, COATED in 1 BOTTLE (53185-362-50)	2014-12-23	0000-00-00	No	No	Current