FDA.reportPublic FDA data

Epsom Salt

Product NDC
55910-038
11-digit product format
559100038
Labeler code
55910
Product ID
55910-038_4c0fcc1c-37a3-384e-e063-6294a90a4e33
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Sulfate
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL; TOPICAL
Labeler
Old East Main Co.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-10-21
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
1 g/g
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
2027-12-31
Current FDA listing
Yes

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 packagepackage55910-03855910-038-43DDiscontinued by firm2026-10-20

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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Epsom Salt
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SK47B8698TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f5Available on FDA.report

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
55910-038-072020-05-21Rexall 602.002/602AA Epsom Salt
55910-038-432020-05-21Rexall 602.002/602AA Epsom Salt
55910-038-072020-01-31Rexall 602.002/602AA Epsom Salt
55910-038-432020-01-31Rexall 602.002/602AA Epsom Salt

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-038-07Epsom Salt1814 g in 1 POUCHGRANULE, FOR SOLUTION181418
55910-038-43Epsom Salt453 g in 1 POUCHGRANULE, FOR SOLUTION45318

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM SULFATEACTIVE INGREDIENTDE08037SABEPSOM SALT (MAGNESIUM SULFATE) GRANULE, FOR SOLUTION [DOLGENCORP, LLC]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838EPSOM SALT (MAGNESIUM SULFATE) GRANULE, FOR SOLUTION [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-038EPSOM SALT (MAGNESIUM SULFATE) GRANULE, FOR SOLUTION [OLD EAST MAIN, CO]16Current NDC, Legacy NDC, 2 package rows20241027_a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 14 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GENTLE LAXATIVEBISACODYLWal-Mart Stores Inc9b466e37-4c7d-4237-8a9d-2994113707f42026-01-26WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Laboratories Limited3cf42333-7479-940a-e063-6394a90aedee2026-01-23WarningsExact identifier
application number: M007
ROYAL Epsom SaltMAGNESIUM SULFATEFilo America40eb04d2-fcc9-4ee2-8483-99699ea7e3862026-01-22WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2de868a0-c652-473c-8b61-636083b7f7572026-01-22WarningsExact identifier
application number: M007
Dr Simi Regular Strength Sennosides 8.6mgSENNOSIDES 8.6MGFarmacias De Similares TX LLC48ed4c5a-136a-90ba-e063-6294a90affed2026-01-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC1f6c3b64-0fcd-4cd3-9947-453d794682922026-01-19WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMWALGREEN COMPANY21fbddce-d3e7-4090-9e69-f4e07fa97ba22026-01-19WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreensd094ba43-7404-43c4-b907-41ab6d02a3c32026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens015e41d2-7543-4210-8345-626f5ae5f81d2026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens2c30de62-b5d2-4905-90a1-a2f9a339fb272026-01-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)0ce164a5-6b2f-4a21-9dca-10301a1f812a2026-01-15WarningsExact identifier
application number: M007
Dulcolax Pink Stool SoftenerDOCUSATE SODIUMChattem, Inc.33fefcf1-9985-4797-9a38-8acaf3979fce2026-01-14WarningsExact identifier
application number: M007
SennaSENNOSIDESAmerican Health Packaginge3cbb71b-b45c-4ce1-820b-959dde04360d2026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy9c6a651a-f062-4784-9d82-156f9f7452232026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy10a9bd9a-181b-69ba-e063-6294a90ac4582026-01-14WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSNa8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f518
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCDa8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f518
1053346Epsom salt 100 % Granules for Oral SolutionSYa8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f518
1053346magnesium sulfate 100 % Granules for Oral SolutionSYa8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-038-07559100038071814 g in 1 POUCH (55910-038-07) 1814 g1993-10-210000-00-00NoNoCurrent
55910-038-4355910003843453 g in 1 POUCH (55910-038-43) 453 g1993-10-210000-00-00NoNoCurrent