Backache Relief

Product NDC
50844-338
11-digit product format
508440338
Labeler code
50844
Product ID
50844-338_42236d39-cccf-47f2-af8c-ab7a2ea89076
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Salicylate Tetrahydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1998-11-07
Marketing end
0000-00-00
Substance
MAGNESIUM SALICYLATE
Active strength
580 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50844-338DDiscontinued by firm2026-08-11
excluded packagepackage50844-33850844-338-22DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50844-338-22d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50844-338-22f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50844-338-222ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50844-338-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50844-338-22cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50844-338-22cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50844-338-22302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50844-338-22ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50844-338-220efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50844-338-22ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50844-338-22367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50844-338-22557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SALICYLATEACTIVE INGREDIENT41728CY7UXBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673BACKACHE RELIEF EXTRA STRENGTH (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-338-22508440338226 BLISTER PACK in 1 CARTON (50844-338-22) > 8 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack1998-11-070000-00-00NoNoCurrent