Home NDC 58037-008 Epsom Salts
Product NDC 58037-008
11-digit product format 580370008
Labeler code 58037
Product ID 58037-008_299acaea-3ece-c645-e063-6294a90a8401
Type HUMAN OTC DRUG
Nonproprietary name Magnesium Sulfate
Dosage form GRANULE
Route ORAL
Labeler NEW PRIDE CORP
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-09
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 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 Salts
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE HEPTAHYDRATE 100 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SK47B8698T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1053346 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58037-008-01 Epsom Salts 454 g in 1 POUCH GRANULE 454 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58037-008 EPSOM SALTS (MAGNESIUM SULFATE) GRANULE [NEW PRIDE CORP] 3 Current NDC, 1 package rows 20241222_f6626023-4857-518b-e053-2a95a90a9821.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 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58037-008-01 58037000801 454 g in 1 POUCH (58037-008-01) 454 g 2019-07-09 No No Current