Home NDC 50438-001 ROYAL Epsom Salt
Product NDC 50438-001
11-digit product format 504380001
Labeler code 50438
Product ID 50438-001_48fdd749-9d9f-c41a-e063-6394a90a7158
Type HUMAN OTC DRUG
Nonproprietary name Magnesium Sulfate
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Filo America
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-29
Substance MAGNESIUM SULFATE, UNSPECIFIED FORM
Active strength 1 kg/kg
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 ROYAL Epsom Salt
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE, UNSPECIFIED FORM 1 kg/kg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DE08037SAB 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 50438-001-00 ROYAL Epsom Salt 1.8 kg in 1 BAG GRANULE, FOR SOLUTION 1.8 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50438-001 ROYAL EPSOM SALT (MAGNESIUM SULFATE) GRANULE, FOR SOLUTION [FILO AMERICA] 5 Current NDC, Legacy NDC, 1 package rows 20231030_40eb04d2-fcc9-4ee2-8483-99699ea7e386.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 Marketing end Sample Exclude flag Status 50438-001-00 50438000100 1.8 kg in 1 BAG (50438-001-00) 1.8 kg 2014-10-29 0000-00-00 No No Current