Naproxen Sodium

Product NDC: 69452-179
11-digit product format: 694520179
Labeler code: 69452
Product ID: 69452-179_0d85dc59-4954-47fc-e063-6394a90a01cd
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bionpharma Inc.
Application: NDA021920
Marketing category: NDA
Marketing start: 2018-11-01
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	2026-08-03
excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	2026-08-03
excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	2026-08-03
excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	2026-08-03
excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 45 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69452-179	69452-179-79	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69452-179	69452-179-78	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69452-179	69452-179-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69452-179	69452-179-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69452-179	69452-179-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021920-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2006-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23
N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23
N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24
N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24
N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24
N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24
N021920-001	9693978	2026-03-03		Drug product	2017-11-13
N021920-001	9693979	2026-03-03		Drug product	2017-11-13

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 313 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`b8a1b40f171c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	9343c79f-9994-4599-bcfe-0a93e49d726e	2026-05-12	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	04a298dc-c525-8198-e063-6294a90a6f96	2026-04-27	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	ba4f927a-4bbe-0d87-e053-2995a90a8c20	2026-04-20	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	MEIJER DISTRIBUTION INC	89f82399-9f71-49dd-8710-b60f346c576c	2025-12-12	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36bf8594-9303-c816-e063-6294a90af705	2025-12-08	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	1266393e-b55e-4e34-9710-0b87209f4158	2025-12-04	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3b5442c6-c6e1-4df3-8cec-40bbb4ec469f	2025-12-04	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Albertsons Companies	f9df7495-9da7-8838-e053-6294a90a6fda	2024-09-30	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	AMERISOURCE BERGEN	16b3bbee-4881-b439-e063-6394a90a7c8f	2024-04-22	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Bionpharma Inc.	3e10256f-0a5f-49e4-9518-a72b10490f89	2023-12-27	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 69452-179
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	fed305f1-e32d-e1ff-e053-6294a90a273d	2023-10-03	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	a359c47e-e2b4-5560-e053-2a95a90a2844	2023-03-03	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	KROGER COMPANY	7487e685-ea64-43a2-9a4e-f5278840be04	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Wal-Mart Stores, Inc.	073ecef7-f5b1-4ee0-98bc-82972e3d84f9	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	a13bd208-f29f-1cbc-e053-2995a90a08ba	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	HEB	df8ea301-c48b-4da4-9e8e-5c69cac6cba7	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	TOP CARE (Topco Associates LLC)	c62b7fa0-5ae9-276c-e053-2995a90ade25	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION INC.	c482db41-b115-c24f-e053-2a95a90a2947	2022-12-21	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	462a7e41-b899-4e08-8113-b48ece0ad8d8	2022-03-17	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	DISCOUNT DRUG MART, INC.	b00c0e86-4c0b-45bf-948f-824ea0f09e39	2022-03-16	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen Sodium
Listing expiration: 2026-12-31

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
3e10256f-0a5f-49e4-9518-a72b10490f89	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69452-179-11	Naproxen Sodium	20 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	20	5
69452-179-15	Naproxen Sodium	40 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	40	5
69452-179-20	Naproxen Sodium	100 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	100	5
69452-179-22	Naproxen Sodium	120 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	120	5
69452-179-78	Naproxen Sodium	80 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	80	5
69452-179-79	Naproxen Sodium	160 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	160	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-179	NAPROXEN SODIUM CAPSULE, LIQUID FILLED [BIONPHARMA INC.]	5	Current NDC, Legacy NDC, 6 package rows	20231228_3e10256f-0a5f-49e4-9518-a72b10490f89.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
1112231	naproxen sodium 220 MG Oral Capsule	PSN	3e10256f-0a5f-49e4-9518-a72b10490f89	5
1112231	naproxen sodium 220 MG Oral Capsule	SCD	3e10256f-0a5f-49e4-9518-a72b10490f89	5
1112231	naproxen sodium 220 MG (as naproxen 200 MG) Oral Capsule	SY	3e10256f-0a5f-49e4-9518-a72b10490f89	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-179-11	69452017911	20 in 1 BOTTLE, PLASTIC					Historical
69452-179-15	69452017915	40 in 1 BOTTLE, PLASTIC					Historical
69452-179-20	69452017920	100 in 1 BOTTLE, PLASTIC					Historical
69452-179-22	69452017922	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-179-22)	2018-11-01	0000-00-00	No	No	Current
69452-179-78	69452017978	80 in 1 BOTTLE, PLASTIC					Historical
69452-179-79	69452017979	160 in 1 BOTTLE, PLASTIC					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium - Bionpharma Inc. \| Patheon Softgels Inc.	Bionpharma Inc. \| Patheon Softgels Inc.	2023-12-27	HUMAN OTC DRUG LABEL	5