FDA.reportPublic FDA data

Epsom Salt

Product NDC
0363-0395
11-digit product format
003630395
Labeler code
0363
Product ID
0363-0395_c5edb3c5-020e-4c0f-9c7a-92b67fba8b99
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium sulfate
Dosage form
GRANULE
Route
ORAL; TOPICAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-30
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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATEWalgreens7365e199-5038-48eb-b0b9-7b46f9894dd72025-09-05WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Ask a doctor before use if you have kidney disease a magnesium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are presently taking a prescription drug. When using this product do not use more than directed Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition. you need to use a laxative for more than 1 week If pregnancy or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Epsom Salt
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE1 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSK47B8698T
Rxcui1053346

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
0363-0395-01Epsom Salt454 g in 1 POUCHGRANULE45415
0363-0395-03Epsom Salt1360 g in 1 POUCHGRANULE136015
0363-0395-04Epsom Salt1810 g in 1 POUCHGRANULE181015
0363-0395-06Epsom Salt2721 g in 1 POUCHGRANULE272115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0395-03GM - Gram0363-0395cee692d3-c089-4e60-b242-25512816cce212022-06-06
0363-0395-04GM - Gram0363-0395b12802ec-a819-4a5c-9d40-f35b58b1238312023-04-07
0363-0395-06GM - Gram0363-0395cb2eb3d5-9a7c-4045-aeb2-56777cf11f3c12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0395EPSOM SALT (MAGNESIUM SULFATE) GRANULE [WALGREENS]14Current NDC, Legacy NDC, 4 package rows20250223_7365e199-5038-48eb-b0b9-7b46f9894dd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053346Epsom salt 100 % Granules for Oral SolutionPSN7365e199-5038-48eb-b0b9-7b46f9894dd715
1053346magnesium sulfate 1000 MG Granules for Oral SolutionSCD7365e199-5038-48eb-b0b9-7b46f9894dd715
1053346Epsom salt 100 % Granules for Oral SolutionSY7365e199-5038-48eb-b0b9-7b46f9894dd715
1053346magnesium sulfate 100 % Granules for Oral SolutionSY7365e199-5038-48eb-b0b9-7b46f9894dd715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0395-0100363039501454 g in 1 POUCH (0363-0395-01) 454 g2016-04-300000-00-00NoNoCurrent
0363-0395-03003630395031360 g in 1 POUCH (0363-0395-03) 1360 g2016-04-300000-00-00NoNoCurrent
0363-0395-04003630395041810 g in 1 POUCH (0363-0395-04) 1810 g2016-04-300000-00-00NoNoCurrent
0363-0395-06003630395062721 g in 1 POUCH (0363-0395-06) 2721 g2016-04-302027-01-30NoNoCurrent