Home NDC 76162-029 Epsom Salt
Product NDC 76162-029
11-digit product format 761620029
Labeler code 76162
Product ID 76162-029_4ab76ef6-281e-f8e9-e063-6294a90a1cc9
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 2021-12-01
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-029-80 Epsom Salt 3630 g in 1 POUCH GRANULE, FOR SOLUTION 3630 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-029 EPSOM SALT (MAGNESIUM SULFATE) GRANULE, FOR SOLUTION [TOPCO ASSOCIATES, LLC] 12 Current NDC, Legacy NDC, 1 package rows 20250524_b2ec06b3-647d-49ab-a392-6db63d96d1e3.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 · 829 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 76162-029-80 76162002980 3630 g in 1 POUCH (76162-029-80) 3630 g 2021-12-01 0000-00-00 No No Current