Naproxen Sodium

Product NDC: 59726-174
Requested package NDC: 59726-174-80
11-digit product format: 597260174
Labeler code: 59726
Product ID: 59726-174_2099e3fb-d761-4735-9935-c51413496741
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: P & L Development, LLC
Application: ANDA208363
Marketing category: ANDA
Marketing start: 2018-04-01
Marketing end: 2026-12-31
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
Current FDA listing: Yes

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, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
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
A208363-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL			2018-03-15

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	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen Sodium

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
1112231	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
fc65fe79-c93b-4247-b9af-e562792a3e64	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59726-174-20	2025-08-19	Drug Facts
59726-174-80	2025-08-19	Drug Facts
59726-174-20	2025-01-30	Drug Facts
59726-174-80	2025-01-30	Drug Facts
59726-174-20	2023-04-19	Drug Facts
59726-174-80	2023-04-19	Drug Facts
59726-174-20	2023-01-30	Drug Facts
59726-174-80	2023-01-30	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59726-174-20	Naproxen Sodium	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	7
59726-174-20	Naproxen Sodium	20 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	20	7
59726-174-80	Naproxen Sodium	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	7
59726-174-80	Naproxen Sodium	80 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	80	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59726-174	NAPROXEN SODIUM CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]	6	Current NDC, Legacy NDC, 4 package rows	20230420_fc65fe79-c93b-4247-b9af-e562792a3e64.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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c28c4fd2-1428-421c-b62f-265e472d833e	2026-07-09	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	c194124b-a5f6-423e-bc9a-7b611df990a8	2026-05-13	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	d9806ad8-1cea-4599-97ef-a956ec7f0e21	2026-03-11	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc.	deb1be0f-64ae-46b5-b54a-1a58eec6492e	2026-01-05	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	fc65fe79-c93b-4247-b9af-e562792a3e64	2025-08-19	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363 ndc (package): 59726-174-80 ndc (product): 59726-174 ndc11 (package): 59726017480
Naproxen Sodium	NAPROXEN SODIUM	AAFES/Your Military Exchanges	c387f7cb-7cc4-4989-9f9a-bb00a895fd0d	2025-05-08	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Productos Zapotol Corp.	6386f6f6-9bc7-4b85-ac87-03fd14725904	2024-03-14	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Productos Zapotol Corp.	0a69f39e-5eb6-4a98-85f0-87e7449672d6	2024-03-14	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Care One (Retail Business Services, LLC.)	5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad	2024-02-21	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
All Day Relief	NAPROXEN SODIUM	Publix Supermarkets, Inc.	4db86c5b-62bb-4638-9f1e-98dc2680d6cc	2024-01-23	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36ce5cd9-8c61-4ed9-b840-c29ad98bdfc5	2023-10-25	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Strategic Sourcing Services LLC	435e55b2-3d75-4a1e-9f00-69b29baf37af	2023-10-02	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Care One (American Sales Company)	043f7032-4e83-4642-93a8-6c09de26b43f	2022-11-21	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Strategic Sourcing Services LLC	a636037d-127c-478d-9d61-dda6eafd2e81	2022-11-15	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de03311d-fb58-43f5-a110-aac9a39c9132	2022-11-07	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
NAPROXEN SODIUM	NAPROXEN SODIUM	PuraCap Pharmaceutical LLC	fc865e81-164c-48e9-8fb9-6fc27d1c33cf	2019-12-10	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
NAPROXEN SODIUM	NAPROXEN SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	1d5981dd-e3f5-48a3-a5f1-ce49689cdfac	2019-11-08	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363

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
1112231	naproxen sodium 220 MG Oral Capsule	PSN	fc65fe79-c93b-4247-b9af-e562792a3e64	7
1112231	naproxen sodium 220 MG Oral Capsule	SCD	fc65fe79-c93b-4247-b9af-e562792a3e64	7
1112231	naproxen sodium 220 MG (as naproxen 200 MG) Oral Capsule	SY	fc65fe79-c93b-4247-b9af-e562792a3e64	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59726-174-80	59726017480	1 BOTTLE, PLASTIC in 1 BOX (59726-174-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2018-04-01	2026-12-31	No	No	Current