Clear Choice Naproxen Sodium

Product NDC: 53185-004
11-digit product format: 531850004
Labeler code: 53185
Product ID: 53185-004_5784dfa2-1c44-2bf7-e053-2a91aa0a4226
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Athlete's Needs Inc
Application: ANDA079096
Marketing category: ANDA
Marketing start: 2013-05-06
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 220 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53185-004		I	Inactivated by FDA		2026-08-03
excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	53185-004		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53185-004	53185-004-00	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	53185-004		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53185-004	53185-004-00	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`cb3db0bc1861…`

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Mediproxen	NAPROXEN SODIUM	Sportpharm LLC	f01adfcc-b32a-4a98-a4e7-2ce87b824b5a	2026-04-24	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a0c910-7dd7-6a42-e063-6394a90a491c	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	HYVEE INC	45a00020-173b-a4a1-e063-6294a90ae399	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	12748345-0d79-d6f8-e063-6394a90ab6c6	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	1274889d-803c-d7fd-e063-6394a90ab9a8	2025-12-11	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	d9e72c3f-addc-4391-a7a4-2680a3e7f5c4	2025-12-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	2ee83008-c012-48d6-9479-65e7d6f50f4c	2025-12-10	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	27938b08-ff37-4587-aa81-5ec3ef21a28a	2025-12-09	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
CAREALL Naproxen	NAPROXEN SODIUM	New World Imports, Inc.	d9a0c6e7-a70e-479a-9737-e81a2887c778	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
CAREALL Naproxen Sodium	NAPROXEN SODIUM	New World Imports, Inc.	3952324e-77f4-4117-a97a-ab5651130058	2025-12-01	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique at Home Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	b591ba4f-d7d3-4c81-e053-2995a90a7c6e	2025-09-09	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Medique Mediproxen	NAPROXEN SODIUM	Unifirst First Aid Corporation	f6261d45-df1f-483b-b013-3cd6f78d9d43	2025-09-08	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	AMERIFOODS TRADING COMPANY	f6dd2150-1643-18ff-e053-6294a90a422b	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	684e03b6-74eb-4374-a512-1c01ea216b51	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Marc Glassman, Inc.	eeda0edf-7054-42aa-af8e-4df38b918f81	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	84b9e9a4-b805-420e-83be-ebe98776d1ee	2025-06-20	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
NAPROXEN SODIUM	NAPROXEN SODIUM	AAA Pharmaceutical, Inc.	5ea3217d-845d-4781-b849-6b00babdc214	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	FSA STORE INC.	f4326f99-142b-0b70-e053-2995a90ac951	2025-06-17	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	Harris Teeter	38543976-ccbe-4af9-b01d-ae102452d418	2025-05-21	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION, INC.	04245a78-228e-439f-8ffb-9d9bc56c7bb7	2025-05-20	Warnings	Exact identifier application applno (ANDA): 079096 application number: ANDA079096

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
53185-004-00	2020-01-31	C162847	48780-1	9d75b9cf-dd2d-f424-e053-dadaa90a57ce	Clear Choice Naproxen Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53185-004-00	Clear Choice Naproxen Sodium	50 in 1 BOTTLE	TABLET	50		4
53185-004-00	Clear Choice Naproxen Sodium	1 in 1 CARTON	TABLET	1		4

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53185-004	CLEAR CHOICE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [ATHLETE'S NEEDS INC]	4	Legacy NDC, 2 package rows	20170918_9a101077-8cf1-4353-836c-598678f52cb6.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	9a101077-8cf1-4353-836c-598678f52cb6	4
849574	naproxen sodium 220 MG Oral Tablet	SCD	9a101077-8cf1-4353-836c-598678f52cb6	4
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	9a101077-8cf1-4353-836c-598678f52cb6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53185-004-00	53185000400	50 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clear Choice Naproxen Sodium	Athlete's Needs Inc \| Allegiant Health	2017-08-24	HUMAN OTC DRUG LABEL	4