Epsom Salt

Product NDC
55312-029
Requested package NDC
55312-029-07
11-digit product format
553120029
Labeler code
55312
Product ID
55312-029_dc8bca48-533b-4088-b150-6ac4e5df6726
Type
HUMAN OTC DRUG
Nonproprietary name
MAGNESIUM SULFATE
Dosage form
GRANULE
Route
ORAL
Labeler
Western Family
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1998-06-05
Marketing end
0000-00-00
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
100 kg/100kg
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55312-02955312-029-07DDiscontinued by firm2026-10-05

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 · 5 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…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATEACTIVE INGREDIENTDE08037SABEPSOM SALT (MAGNESIUM SULFATE ) GRANULE [WESTERN FAMILY]3
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838EPSOM SALT (MAGNESIUM SULFATE ) GRANULE [WESTERN FAMILY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-029EPSOM SALT (MAGNESIUM SULFATE) GRANULE [WESTERN FAMILY]14Legacy NDC20240331_8d0b341f-81b4-49a0-a712-1e0c79f778fc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55312-029-07553120029071.81 kg in 1 POUCH (55312-029-07) 1.81 kg1998-06-050000-00-00NoNoCurrent