Naproxen Sodium

Product NDC: 55319-168
11-digit product format: 553190168
Labeler code: 55319
Product ID: 55319-168_6708cae8-44fd-4c60-9094-f347714648eb
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: ANDA079096
Marketing category: ANDA
Marketing start: 2012-08-15
Marketing end: 2025-01-31
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
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55319-168		D	Discontinued by firm	2026-10-12
excluded package	package	55319-168	55319-168-01	D	Discontinued by firm	2026-10-12
excluded package	package	55319-168	55319-168-24	D	Discontinued by firm	2026-10-12
excluded package	package	55319-168	55319-168-50	D	Discontinued by firm	2026-10-12

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-168-24	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-168-50	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-168-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-168-24	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-168-50	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-168-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55319-168-24	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55319-168-50	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55319-168-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55319-168-24	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55319-168-50	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55319-168-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55319-168-24	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55319-168-50	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55319-168-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55319-168-24	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55319-168-50	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55319-168-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55319-168-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55319-168-24	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55319-168-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55319-168-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55319-168-24	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55319-168-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55319-168-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55319-168-24	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55319-168-50	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55319-168-01	2022-10-31	Drug Facts
55319-168-24	2022-10-31	Drug Facts
55319-168-50	2022-10-31	Drug Facts
55319-168-01	2022-01-28	Drug Facts
55319-168-24	2022-01-28	Drug Facts
55319-168-50	2022-01-28	Drug Facts

DailyMed Socrata Ingredients#

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

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	c1dce2e4-ad7a-4462-a775-9a5bcb2375ed	2025-05-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
NAPROXEN	NAPROXEN SODIUM	DISCOUNT DRUG MART	a0c67043-1e78-4eac-86e6-497b4364651a	2025-05-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	WinCo Foods, LLC	44ef3ef4-9495-4a63-92f0-f0ab19c4ec23	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	WinCo Foods, LLC	074fc2b9-743b-458e-a0c0-d5f27633bbf3	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
All Day Pain Relief	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	48059718-4e35-479c-a549-ac534d3ba899	2024-12-04	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
All Day Pain Relief	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	593b915f-045a-40b7-b86e-0d1cb41f2bb8	2024-12-04	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Lil Drug Store Pain Relief All Day	NAPROXEN SODIUM	Lil' Drug Store Products, Inc.	41d2d995-47ef-419d-8e57-ea3f9f8a9f68	2024-03-29	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique Mediproxen	NAPROXEN SODIUM	A-S Medication Solutions	2d04fef4-6a26-4df2-af90-816107e7dfe2	2024-02-02	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever	NAPROXEN SODIUM	Amneal Pharmaceuticals of New York LLC	0bb41b8c-6031-4e96-95e1-31adab811837	2023-12-31	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
All Day Pain Relief	NAPROXEN SODIUM	H E B	6dd54a14-67cd-4295-9bd5-1d6f8cb9316d	2023-12-19	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Belmora Flanax	NAPROXEN SODIUM	Unifirst First Aid Corporation	8591ca57-04ee-5053-e053-2991aa0aa4dd	2023-01-10	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-168-01	55319016801	1 BOTTLE, PLASTIC in 1 BOX (55319-168-01) > 100 TABLET in 1 BOTTLE, PLASTIC	2012-08-15	2025-01-31	No	No	Current
55319-168-24	55319016824	1 BOTTLE, PLASTIC in 1 BOX (55319-168-24) > 24 TABLET in 1 BOTTLE, PLASTIC	2012-08-15	2025-01-31	No	No	Current
55319-168-50	55319016850	1 BOTTLE, PLASTIC in 1 BOX (55319-168-50) > 50 TABLET in 1 BOTTLE, PLASTIC	2012-08-15	2025-01-31	No	No	Current