Sound Body Naproxen Sodium

Product NDC: 50594-024
11-digit product format: 505940024
Labeler code: 50594
Product ID: 50594-024_48730f79-9c81-4a00-8e43-61b579a76982
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Big Lots Stores, Inc.
Application: ANDA074661
Marketing category: ANDA
Marketing start: 2017-04-20
Marketing end: 0000-00-00
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50594-024		D	Discontinued by firm	2026-10-12
excluded package	package	50594-024	50594-024-71	D	Discontinued by firm	2026-10-12
excluded package	package	50594-024	50594-024-75	D	Discontinued by firm	2026-10-12
excluded package	package	50594-024	50594-024-78	D	Discontinued by firm	2026-10-12

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
A074661-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1997-01-13

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 · 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	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50594-024	SOUND BODY NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BIG LOTS STORES, INC.]	6	Legacy NDC	20240901_133ae6de-e8b4-4351-aab1-a70dec61dde9.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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	51e49a00-e040-4e7b-838c-c77ed75a7f92	2025-01-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Basic Care Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	d5c185d9-0bea-4970-b1e7-201a51106ad6	2025-01-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	3ca9ce63-39f4-4ba9-b464-d048fd8e67c0	2025-01-15	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
All Day Pain Relief	NAPROXEN SODIUM	Walgreen Company	318d4e2a-7108-4e88-8e56-5bec17ca4a3e	2025-01-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
DG Health Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp Inc	43926764-f8d1-42b4-b55b-0524d9ff98f3	2024-12-27	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
exchange select naproxen sodium	NAPROXEN SODIUM	Army & Air Force Exchange Service	5294f434-62c2-4393-9c9e-c94dd9a19687	2024-12-07	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Topcare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	f151d48d-a8f7-484e-9ce8-6b2e8dd1093f	2024-04-25	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	535a6531-3372-4206-b97b-f26a16b6d80c	2024-04-25	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
good sense naproxen sodium	NAPROXEN SODIUM	L. Perrigo Company	a980b939-f74d-4e95-87a8-65ad5a783ac5	2024-02-19	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Basic Care Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	4bc62f12-15a5-40bd-bf99-ec15de0914c7	2024-02-15	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	CVS Pharmacy	f246ff56-23e4-4d39-9d73-7c0dd2b99fd3	2023-08-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
all day pain relief	NAPROXEN SODIUM	Walgreen Company	8ea540bf-4958-41f9-980f-5936c074a51d	2023-05-08	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	A-S Medication Solutions	2523a4de-1af9-46f4-93dc-e8b4029d69c4	2023-04-27	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	e668c80f-dd53-4b82-8678-5e4fccb13023	2022-05-02	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
betr headache pain relief	NAPROXEN SODIUM	Live Betr LLC	eaf6d2fc-ebcb-4d11-8e3f-a494f0f7920b	2022-04-01	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	c0dc7f87-355c-4357-b99d-f03693d350a7	2019-11-01	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50594-024-71	50594002471	1 BOTTLE in 1 CARTON (50594-024-71) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-04-25	0000-00-00	No	No	Current
50594-024-75	50594002475	1 BOTTLE in 1 CARTON (50594-024-75) > 90 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-08-11	0000-00-00	No	No	Current
50594-024-78	50594002478	1 BOTTLE in 1 CARTON (50594-024-78) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2017-04-20	0000-00-00	No	No	Current