FDA.reportPublic FDA data

Epsom Salts

Product NDC
22431-124
Requested package NDC
22431-124-03
11-digit product format
224310124
Labeler code
22431
Product ID
22431-124_ed86046f-55cb-ae28-e053-2a95a90a7383
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Sulfate Heptahydrate
Dosage form
GRANULE
Route
ORAL
Labeler
Blue Cross Laboratories, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-07-09
Marketing end
0000-00-00
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
100 g/100g
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 packagepackage22431-12422431-124-03IInactivated by FDA2026-10-16

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
22431-124-012024-01-30Relief Epsom Salt
22431-124-022024-01-30Relief Epsom Salt
22431-124-032024-01-30Relief Epsom Salt
22431-124-042024-01-30Relief Epsom Salt
22431-124-012022-03-07Relief Epsom Salt
22431-124-022022-03-07Relief Epsom Salt
22431-124-032022-03-07Relief Epsom Salt
22431-124-042022-03-07Relief Epsom Salt
22431-124-012022-01-28Relief Epsom Salt
22431-124-022022-01-28Relief Epsom Salt
22431-124-032022-01-28Relief Epsom Salt
22431-124-042022-01-28Relief Epsom Salt

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22431-124-01Epsom SaltsRelief1810 g in 1 BAGGRANULE181022
22431-124-02Epsom SaltsRelief454 g in 1 BAGGRANULE45422
22431-124-03Epsom SaltsRelief454 g in 1 CARTONGRANULE45422
22431-124-04Epsom SaltsRelief907 g in 1 BAGGRANULE90722

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATE HEPTAHYDRATEACTIVE INGREDIENTSK47B8698TEPSOM SALTS RELIEF (MAGNESIUM SULFATE HEPTAHYDRATE) GRANULE [BLUE CROSS LABORATORIES, INC. ]17
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838EPSOM SALTS RELIEF (MAGNESIUM SULFATE HEPTAHYDRATE) GRANULE [BLUE CROSS LABORATORIES, INC. ]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22431-124EPSOM SALTS RELIEF (MAGNESIUM SULFATE HEPTAHYDRATE) GRANULE [BLUE CROSS LABORATORIES, INC.]22Legacy NDC, 4 package rows20221116_d4937f2c-095d-40ca-94e7-6d88df95768e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSNd4937f2c-095d-40ca-94e7-6d88df95768e22
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCDd4937f2c-095d-40ca-94e7-6d88df95768e22
1053346Epsom salt 100 % Granules for Oral SolutionSYd4937f2c-095d-40ca-94e7-6d88df95768e22
1053346magnesium sulfate 100 % Granules for Oral SolutionSYd4937f2c-095d-40ca-94e7-6d88df95768e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
22431-124-0322431012403454 g in 1 CARTON (22431-124-03) 454 g2015-04-240000-00-00NoNoCurrent