Home NDC 36800-395 Epsom Salt
Product NDC 36800-395
11-digit product format 368000395
Labeler code 36800
Product ID 36800-395_e587abe0-64ee-4bad-814c-9f96f4b36859
Type HUMAN OTC DRUG
Nonproprietary name Magnesium sulfate
Dosage form GRANULE
Route ORAL; TOPICAL
Labeler TOP CARE (Topco Associates LLC)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-30
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 36800-395-01 Epsom Salt 454 g in 1 CARTON GRANULE 454 12 36800-395-04 Epsom Salt 1810 g in 1 CARTON GRANULE 1810 12 36800-395-10 Epsom Salt 454 g in 1 POUCH GRANULE 454 12 36800-395-40 Epsom Salt 1814 g in 1 POUCH GRANULE 1814 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-395 EPSOM SALT (MAGNESIUM SULFATE) GRANULE [TOP CARE (TOPCO ASSOCIATES LLC)] 11 Current NDC, Legacy NDC, 4 package rows 20250316_b1222ba6-390d-478d-905b-994fff4d6d58.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 14 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 36800-395-01 36800039501 454 g in 1 CARTON (36800-395-01) 454 g 2014-04-30 0000-00-00 No No Current 36800-395-04 36800039504 1810 g in 1 CARTON (36800-395-04) 1810 g 2014-04-30 0000-00-00 No No Current 36800-395-10 36800039510 454 g in 1 POUCH (36800-395-10) 454 g 2014-04-30 0000-00-00 No No Current 36800-395-40 36800039540 1814 g in 1 POUCH (36800-395-40) 1814 g 2014-04-30 0000-00-00 No No Current