Naproxen

Product NDC: 68071-5039
11-digit product format: 680715039
Labeler code: 68071
Product ID: 68071-5039_5d43b461-8500-f82f-e063-6394a90acd7d
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA204872
Marketing category: ANDA
Marketing start: 2019-01-01
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: 2027-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-5039-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-5039-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-5039-1	`0efc9e666f02…`	`f202fb6c5f17…`

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
A204872-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2017-01-23

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	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

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#

Effective, Related label table
Effective	Related label
2025-02-04	gc 951-954L
2025-02-04	gc 951-954L
2025-01-30	gc 951-954L
2025-01-30	gc 951-954L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5039-1	Naproxen	21 in 1 BOTTLE	TABLET	21		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5039	NAPROXEN (NAPROXEN SODIUM) TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250206_f1ed8384-83d6-6f2a-e053-2a95a90ab08f.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Direct All Day Pain Relief	NAPROXEN SODIUM	Cintas Corporation	1c9384c1-52f8-4482-88fc-5f5b6d770c42	2025-09-22	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Geri-Care Pharmaceutical Corp	9a61d544-e46d-6703-e053-2a95a90a32fd	2025-02-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Bryant Ranch Prepack	f9ddc614-26b7-48dc-ae93-02da6388f2d5	2025-01-30	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Proficient Rx LP	2acd8e24-449d-4f5c-9323-504013ff4bf5	2023-07-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872

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	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	3
849574	naproxen sodium 220 MG Oral Tablet	SCD	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	3
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5039-1	68071503901	21 TABLET in 1 BOTTLE (68071-5039-1)	21 tablet	2023-01-10	0000-00-00	No	No	Current
68071-5039-3	68071503903	30 TABLET in 1 BOTTLE (68071-5039-3)	30 tablet	2026-10-07		No	No	Current