Home NDC 49580-0394 Epsom Salt
Product NDC 49580-0394
11-digit product format 495800394
Labeler code 49580
Product ID 49580-0394_f9e5500b-c902-49a4-a680-70dbf68304f0
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 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.
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 Ingredient Strength MAGNESIUM SULFATE, UNSPECIFIED 1 g/g
Harmonized Identifiers# Field, Values table Field Values Unii DE08037SAB Rxcui 1053346
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0394-1 Epsom Salt 454 g in 1 POUCH GRANULE 454 14 49580-0394-2 Epsom Salt 907 g in 1 POUCH GRANULE 907 14 49580-0394-3 Epsom Salt 1361 g in 1 POUCH GRANULE 1361 14 49580-0394-4 Epsom Salt 1814 g in 1 POUCH GRANULE 1814 14 49580-0394-8 Epsom Salt 3628 g in 1 POUCH GRANULE 3628 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0394 EPSOM SALT GRANULE [P & L DEVELOPMENT, LLC] 13 Current NDC, Legacy NDC, 5 package rows 20250321_a343bb9f-0b63-4464-99a0-f7137cd2125a.zip
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 49580-0394-1 49580039401 454 g in 1 POUCH (49580-0394-1) 454 g 2017-12-31 0000-00-00 No No Current 49580-0394-2 49580039402 907 g in 1 POUCH (49580-0394-2) 907 g 2017-12-31 0000-00-00 No No Current 49580-0394-3 49580039403 1361 g in 1 POUCH (49580-0394-3) 1361 g 2017-12-31 No No Current 49580-0394-4 49580039404 1814 g in 1 POUCH (49580-0394-4) 1814 g 2017-12-31 0000-00-00 No No Current 49580-0394-8 49580039408 3628 g in 1 POUCH (49580-0394-8) 3628 g 2017-12-31 0000-00-00 No No Current