Salsalate

Product NDC: 10135-493
11-digit product format: 101350493
Labeler code: 10135
Product ID: 10135-493_d1e8c1cb-498f-45ef-880c-a5c05985f75a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Salsalate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2007-04-01
Marketing end: 0000-00-00
Substance: SALSALATE
Active strength: 750 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	10135-493		I	Inactivated by FDA	2026-08-11
excluded package	package	10135-493	10135-493-01	I	Inactivated by FDA	2026-08-11
excluded package	package	10135-493	10135-493-05	I	Inactivated by FDA	2026-08-11
excluded package	package	10135-493	10135-493-10	I	Inactivated by FDA	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 · 80 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	10135-493-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-493-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-493-05	`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	10135-493-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-493-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-493-05	`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	10135-493-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-493-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-493-05	`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	10135-493-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-493-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-493-05	`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	10135-493-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-493-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-493-05	`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	10135-493-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-493-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-493-05	`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	10135-493-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-493-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-493-05	`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	10135-493-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-493-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-493-05	`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	10135-493-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-493-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-493-05	`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	10135-493-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-493-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-493-05	`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	10135-493-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-493-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-493-05	`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	10135-493-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-493-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-493-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-493-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-493-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-493-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-493-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-493-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-493-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-493-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-493-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-493-05	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10135-493-01	2022-01-28	Salsalate
10135-493-05	2022-01-28	Salsalate
10135-493-10	2022-01-28	Salsalate
10135-493-01	2019-12-18	Salsalate
10135-493-05	2019-12-18	Salsalate
10135-493-10	2019-12-18	Salsalate
10135-493-01	2019-10-29	Salsalate
10135-493-05	2019-10-29	Salsalate
10135-493-10	2019-10-29	Salsalate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-493-01	Salsalate	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
10135-493-05	Salsalate	500 in 1 BOTTLE	TABLET, FILM COATED	500	6
10135-493-10	Salsalate	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-493-01	EA - Each	10135-493	9d2145ba-8932-4c0f-ab0f-f6c930a323ed	1	2012-07-24
10135-493-05	EA - Each	10135-493	66576761-0bb5-4a71-bc28-4bfa1d3490ba	1	2012-07-24
10135-493-10	EA - Each	10135-493	b992db74-ca4c-42f0-a382-daf15503b94a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALSALATE	ACTIVE INGREDIENT	V9MO595C9I	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
SALSALATE	ACTIVE MOIETY	V9MO595C9I	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-493	SALSALATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	6	Legacy NDC, 3 package rows	20191219_1e63322d-8171-48a0-93db-6f737630fe16.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312899	salsalate 500 MG Oral Tablet	PSN	1e63322d-8171-48a0-93db-6f737630fe16	6
583170	salsalate 750 MG Oral Tablet	PSN	1e63322d-8171-48a0-93db-6f737630fe16	6
312899	salsalate 500 MG Oral Tablet	SCD	1e63322d-8171-48a0-93db-6f737630fe16	6
583170	salsalate 750 MG Oral Tablet	SCD	1e63322d-8171-48a0-93db-6f737630fe16	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-493-01	10135049301	100 in 1 BOTTLE	Historical
10135-493-05	10135049305	500 in 1 BOTTLE	Historical
10135-493-10	10135049310	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salsalate	Marlex Pharmaceuticals Inc	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	6
Salsalate	Aphena Pharma Solutions - Tennessee, LLC	2017-12-20	HUMAN PRESCRIPTION DRUG LABEL	1