Salsalate

Product NDC: 42937-704
11-digit product format: 429370704
Labeler code: 42937
Product ID: 42937-704_2357c10f-19f4-4225-b765-640c98ee90f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Salsalate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Nationwide Laboratories, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-08-19
Marketing end: 0000-00-00
Substance: SALSALATE
Active strength: 750 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42937-704		D	Discontinued by firm	2026-08-11
excluded package	package	42937-704	42937-704-10	D	Discontinued by firm	2026-08-11
excluded package	package	42937-704	42937-704-16	D	Discontinued by firm	2026-08-11
excluded package	package	42937-704	42937-704-18	D	Discontinued by firm	2026-08-11
excluded package	package	42937-704	42937-704-20	D	Discontinued by firm	2026-08-11

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 2 · 65 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42937-704-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42937-704-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42937-704-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42937-704-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42937-704-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42937-704-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42937-704-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42937-704-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42937-704-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42937-704-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42937-704-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42937-704-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42937-704-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42937-704-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42937-704-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42937-704-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42937-704-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42937-704-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42937-704-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42937-704-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42937-704-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42937-704-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42937-704-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42937-704-16	`cdf11ea48f46…`	`ba0047e9e063…`
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	42937-704-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42937-704-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42937-704-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42937-704-16	`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	42937-704-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42937-704-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42937-704-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42937-704-16	`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	42937-704-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42937-704-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42937-704-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42937-704-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42937-704-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42937-704-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42937-704-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42937-704-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42937-704-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42937-704-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42937-704-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42937-704-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42937-704-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42937-704-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42937-704-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42937-704-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
42937-704-10	2020-02-28	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-16	2020-02-28	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-18	2020-02-28	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-20	2020-02-28	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-10	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-16	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-18	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg
42937-704-20	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42937-704-20	EA - Each	42937-704	f3a85ac8-f15b-4eee-80b5-9b112e946ea2	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Salsalate	ACTIVE INGREDIENT	V9MO595C9I	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Salsalate	ACTIVE MOIETY	V9MO595C9I	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9MO595C9I	SALSALATE	552-94-3	SALSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42937-704-10	42937070410	100 TABLET, FILM COATED in 1 BOTTLE (42937-704-10)	2011-08-19	0000-00-00	No	No	Current
42937-704-16	42937070416	250 TABLET, FILM COATED in 1 BOTTLE (42937-704-16)	2011-08-19	0000-00-00	No	No	Current
42937-704-18	42937070418	500 TABLET, FILM COATED in 1 BOTTLE (42937-704-18)	2011-08-19	0000-00-00	No	No	Current
42937-704-20	42937070420	1000 TABLET, FILM COATED in 1 BOTTLE (42937-704-20)	2011-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salsalate Tablets, USP 500 mg and 750 mg	Nationwide Laboratories, LLC	2020-02-28	HUMAN PRESCRIPTION DRUG LABEL	2