Naproxen Sodium

Product NDC: 55319-761
Requested package NDC: 55319-761-10
11-digit product format: 553190761
Labeler code: 55319
Product ID: 55319-761_ba16adf1-6f52-b473-e053-2a95a90a7219
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: FAMILY DOLLAR
Application: ANDA091353
Marketing category: ANDA
Marketing start: 2018-10-01
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#

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55319-761	55319-761-10	I	Inactivated by FDA		2026-07-31

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
A091353-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-09-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-09-20	`a50c72e98297…`

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rapidol Naproxen	NAPROXEN SODIUM	Pharmadel LLC	c94c4b6e-a48b-cee5-e053-2995a90a49ac	2026-03-20	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Granules USA, Inc.	8cb8030c-b281-315c-e053-2a95a90a36f0	2025-12-22	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen	NAPROXEN	Safeway, Inc	f2a273f8-d623-dc2f-e053-2995a90a0c02	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc	f2a297c2-3898-5e47-e053-2995a90ab3cc	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	TARGET CORPORATION	fdb87abd-3176-dd62-e053-6394a90a6fcc	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	CVS	1042b202-e8ee-1839-e063-6294a90ac90b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	CVS	10429d07-de96-5542-e063-6294a90a7371	2025-12-19	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Dr Simi All Day Pain Relief	NAPROXEN SODIUM	Farmacias De Similares TX LLC	3c6d4bb5-eb6f-944b-e063-6294a90ae8de	2025-08-15	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Bi-Mart	6d5cecc9-5095-477b-bfc7-45b6e7e689f0	2025-03-01	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
NAPROXEN SODIUM	NAPROXEN SODIUM	SPIRIT PHARMACEUTICALS,LLC	a690dc39-95f2-4853-a291-05d7dc9a1551	2024-12-30	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Pain Relief	NAPROXEN SODIUM	Gobrands, Inc	ae4bfa8c-ae41-4fcd-b584-872cc4d37683	2024-12-20	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
PROXEN NP 660	NAPROXEN SODIUM	OPMX LLC	09990b2f-202e-b4df-e063-6394a90a055b	2023-12-27	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
Naproxen Sodium	NAPROXEN SODIUM	Granules India Ltd	95ba1722-60ed-4a83-9f26-50c4de8cf180	2023-02-06	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353
All Day Pain Relief	NAPROXEN SODIUM TABLETS, 220 MG	HealthLife of USA LLC	7b0cb91e-5465-40ef-9f82-919f7d984f17	2017-06-01	Warnings	Exact identifier application applno (ANDA): 091353 application number: ANDA091353

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
55319-761-05	2023-01-30	C162847	48780-1	f386c649-ff2d-0266-e053-dadaa90a7c1a	ALL DAY PAIN RELIEF Naproxen Sodium Tablets USP, 220 mg (NSAID)** Pain Reliever/Fever Reducer Strength to Last 12 Hours
55319-761-07	2023-01-30	C162847	48780-1	f386c649-ff2d-0266-e053-dadaa90a7c1a	ALL DAY PAIN RELIEF Naproxen Sodium Tablets USP, 220 mg (NSAID)** Pain Reliever/Fever Reducer Strength to Last 12 Hours
55319-761-10	2023-01-30	C162847	48780-1	f386c649-ff2d-0266-e053-dadaa90a7c1a	ALL DAY PAIN RELIEF Naproxen Sodium Tablets USP, 220 mg (NSAID)** Pain Reliever/Fever Reducer Strength to Last 12 Hours

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55319-761-05	Naproxen Sodium	50 in 1 BOTTLE	TABLET	50	3
55319-761-07	Naproxen Sodium	15 in 1 BOTTLE	TABLET	15	3
55319-761-10	Naproxen Sodium	100 in 1 BOTTLE	TABLET	100	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-761	NAPROXEN SODIUM TABLET [FAMILY DOLLAR]	3	Legacy NDC, 3 package rows	20210131_76cb050c-dd11-ff4d-e053-2991aa0a6600.zip

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	76cb050c-dd11-ff4d-e053-2991aa0a6600	3
849574	naproxen sodium 220 MG Oral Tablet	SCD	76cb050c-dd11-ff4d-e053-2991aa0a6600	3
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	76cb050c-dd11-ff4d-e053-2991aa0a6600	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-761-10	55319076110	100 TABLET in 1 BOTTLE (55319-761-10)	100 tablet	2018-10-01	0000-00-00	No	No	Current