FDA.reportPublic FDA data

Epsom Salt

Product NDC
49580-0394
11-digit product format
495800394
Labeler code
49580
Product ID
49580-0394_c055289e-5b85-476a-a160-20ceb61776ec
Type
HUMAN OTC DRUG
Nonproprietary name
Epsom Salt
Dosage form
GRANULE
Route
ORAL; TOPICAL
Labeler
P & L Development, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-31
Substance
MAGNESIUM SULFATE, UNSPECIFIED
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

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, UNSPECIFIED1 g/g

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0394-1Epsom Salt454 g in 1 POUCHGRANULE45414
49580-0394-2Epsom Salt907 g in 1 POUCHGRANULE90714
49580-0394-3Epsom Salt1361 g in 1 POUCHGRANULE136114
49580-0394-4Epsom Salt1814 g in 1 POUCHGRANULE181414
49580-0394-8Epsom Salt3628 g in 1 POUCHGRANULE362814

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0394EPSOM SALT GRANULE [P & L DEVELOPMENT, LLC]13Current NDC, Legacy NDC, 5 package rows20250321_a343bb9f-0b63-4464-99a0-f7137cd2125a.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 8 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxomilBISACODYL 5MGPharmadel LLC3999935b-d8e8-52a6-e063-6294a90aa2a22026-03-20WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGGrocery Outletc820e6a1-fa23-447a-9ee9-50a1bd617adb2026-03-19WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLC9d5f2244-a610-4d45-b6e8-e79bb17a558f2026-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.f178b31d-4843-4b91-a0d5-ab5ade835dc22026-03-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c2026-03-13WarningsExact identifier
application number: M007
Castor OilCASTOR OILOld East Main Co.a1ca668a-3bf9-46a9-8a4f-5cb61547bb812026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILVi-Jon, LLCb29775df-8470-4fe3-bee3-f0490ea6903f2026-03-12WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCcc43d514-ee82-4314-99b2-c64380f987792026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILFoundation Consumer Brands7992a4bb-5535-4a1d-867d-a99f7e0c1be72026-03-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreenscda27a9c-9175-4b07-9c0b-d8d8978829652026-03-12WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Lemon FlavorMAGNESIUM CITRATEUniversal Distribution Center LLCaa02c9af-22b8-4ec2-9e43-fe073f5e617b2026-03-11WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Grape FlavorMAGNESIUM CITRATEUniversal Distribution Center LLC021ebb61-2466-4272-8f7d-b49cafd087542026-03-11WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Cherry FlavorMAGNESIUM CITRATEUniversal Distribution Center LLC1f14411b-6833-40e6-b1a5-2b8c5bf709d32026-03-11WarningsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLCf83ba007-734d-4910-87cb-02e45285e1612026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLC57e914fa-8fa2-4221-bb5f-534f0ea0aba72026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLCf28a9043-e0ee-4b38-95d9-d3f23d4006912026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAmerisource Bergen4caf0bcb-c1bf-0ae7-e063-6294a90a344b2026-03-10WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens92df761b-da68-4ce9-b02a-a5a74fd6620e2026-03-10WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSNa343bb9f-0b63-4464-99a0-f7137cd2125a14
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCDa343bb9f-0b63-4464-99a0-f7137cd2125a14
1053346Epsom salt 100 % Granules for Oral SolutionSYa343bb9f-0b63-4464-99a0-f7137cd2125a14
1053346magnesium sulfate 100 % Granules for Oral SolutionSYa343bb9f-0b63-4464-99a0-f7137cd2125a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0394-149580039401454 g in 1 POUCH (49580-0394-1) 454 g2017-12-310000-00-00NoNoCurrent
49580-0394-249580039402907 g in 1 POUCH (49580-0394-2) 907 g2017-12-310000-00-00NoNoCurrent
49580-0394-3495800394031361 g in 1 POUCH (49580-0394-3) 1361 g2017-12-31NoNoCurrent
49580-0394-4495800394041814 g in 1 POUCH (49580-0394-4) 1814 g2017-12-310000-00-00NoNoCurrent
49580-0394-8495800394083628 g in 1 POUCH (49580-0394-8) 3628 g2017-12-310000-00-00NoNoCurrent