Home NDC 36800-602 Epsom Salt
Product NDC 36800-602
11-digit product format 368000602
Labeler code 36800
Product ID 36800-602_4ab99ba6-4ad5-76c2-e063-6394a90ab4be
Type HUMAN OTC DRUG
Nonproprietary name Magnesium Sulfate
Dosage form GRANULE, FOR SOLUTION
Route ORAL; TOPICAL
Labeler Topco Associates LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 1999-07-15
Substance MAGNESIUM SULFATE HEPTAHYDRATE
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-602 36800-602-80 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-602 36800-602-80 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 HEPTAHYDRATE 1 g/g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-602-07 Epsom Salt 1814 g in 1 POUCH GRANULE, FOR SOLUTION 1814 18 36800-602-43 Epsom Salt 454 g in 1 POUCH GRANULE, FOR SOLUTION 454 18 36800-602-80 Epsom Salt 3628 g in 1 POUCH GRANULE, FOR SOLUTION 3628 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-602 EPSOM SALT (MAGNESIUM SULFATE) GRANULE, FOR SOLUTION [TOPCO ASSOCIATES, LLC] 16 Current NDC, Legacy NDC, 3 package rows 20241027_72f69aa0-381a-4e5c-975d-3a73fdc1b377.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 36800-602-01 36800060201 454 g in 1 POUCH (36800-602-01) 454 g 1999-07-15 0000-00-00 No No Current 36800-602-07 36800060207 1814 g in 1 POUCH (36800-602-07) 1814 g 1999-07-15 0000-00-00 No No Current 36800-602-43 36800060243 454 g in 1 POUCH (36800-602-43) 454 g 1999-07-15 0000-00-00 No No Current 36800-602-80 36800060280 3628 g in 1 POUCH 3628 g Historical