Home NDC 49580-0394 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 Ingredient Strength MAGNESIUM SULFATE, UNSPECIFIED 1 g/g
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
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 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