Salsalate

Product NDC
42937-704
Requested package NDC
42937-704-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42937-70442937-704-10DDiscontinued by firm2026-08-11

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 1 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42937-704-20EA - Each42937-704f3a85ac8-f15b-4eee-80b5-9b112e946ea212014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SalsalateACTIVE INGREDIENTV9MO595C9ISALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
SalsalateACTIVE MOIETYV9MO595C9ISALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZSALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61USALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GSALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOSALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPSALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ASALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4SALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APSALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
TalcINACTIVE INGREDIENT7SEV7J4R1USALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPSALSALATE TABLET, FILM COATED [NATIONWIDE LABORATORIES, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42937-704-1042937070410100 TABLET, FILM COATED in 1 BOTTLE (42937-704-10) 2011-08-190000-00-00NoNoCurrent