Naproxen

Product NDC: 61010-4410
Requested package NDC: 61010-4410-2
11-digit product format: 610104410
Labeler code: 61010
Product ID: 61010-4410_f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Safetec of America, Inc.
Application: ANDA091353
Marketing category: ANDA
Marketing start: 2020-01-20
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 220 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61010-4410	61010-4410-2	I	Inactivated by FDA		2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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.

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	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`f41ea6bd6efb…`

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
61010-4410-0	2024-01-30	C162847	48780-1	1030e365-0fcb-111a-e063-dadaa90a10e2	287a381a-df7e-4e93-b097-1efde8a5f120
61010-4410-1	2024-01-30	C162847	48780-1	1030e365-0fcb-111a-e063-dadaa90a10e2	287a381a-df7e-4e93-b097-1efde8a5f120
61010-4410-2	2024-01-30	C162847	48780-1	1030e365-0fcb-111a-e063-dadaa90a10e2	287a381a-df7e-4e93-b097-1efde8a5f120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-4410-0	Naproxen	1 in 1 POUCH	TABLET	1	2
61010-4410-1	Naproxen	50 in 1 CARTON	TABLET	50	2
61010-4410-2	Naproxen	100 in 1 CARTON	TABLET	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-4410	NAPROXEN (NAPROXEN SODIUM) TABLET [SAFETEC OF AMERICA, INC.]	2	Legacy NDC, 3 package rows	20200125_287a381a-df7e-4e93-b097-1efde8a5f120.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 · 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

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	287a381a-df7e-4e93-b097-1efde8a5f120	2
849574	naproxen sodium 220 MG Oral Tablet	SCD	287a381a-df7e-4e93-b097-1efde8a5f120	2
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	287a381a-df7e-4e93-b097-1efde8a5f120	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-4410-2	61010441002	100 POUCH in 1 CARTON (61010-4410-2) > 1 TABLET in 1 POUCH (61010-4410-0)	100 pouch	2020-01-20	0000-00-00	No	No	Current