FDA.reportPublic FDA data

Epsom Salt

Product NDC
63868-937
11-digit product format
638680937
Labeler code
63868
Product ID
63868-937_5e096122-b484-4a81-9b01-b806e1936471
Type
HUMAN OTC DRUG
Nonproprietary name
Epsom Salt
Dosage form
GRANULE
Route
ORAL; TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-12-31
Marketing end
0000-00-00
Substance
MAGNESIUM SULFATE, UNSPECIFIED
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-937DDiscontinued by firm2026-10-05
excluded packagepackage63868-93763868-937-04DDiscontinued by firm2026-10-05
excluded packagepackage63868-93763868-937-16DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63868-937-042023-05-02Drug Facts
63868-937-162023-05-02Drug Facts
63868-937-042023-01-30Drug Facts
63868-937-162023-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-937-04GM - Gram63868-937659c38f6-83e0-4507-a15e-4a2e01a6282812019-11-12
63868-937-16GM - Gram63868-9371eb59b2c-a249-4e31-b9fa-579608dbd9d812018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-937EPSOM SALT GRANULE [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Legacy NDC20230504_3b3ab0b0-af82-4e89-95bc-0766a952e4c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-937-04638680937041814 g in 1 POUCH (63868-937-04) 1814 g2017-12-310000-00-00NoNoCurrent
63868-937-1663868093716454 g in 1 POUCH (63868-937-16) 454 g2017-12-310000-00-00NoNoCurrent