Home NDC 51316-395 Epsom Salt
Product NDC 51316-395
11-digit product format 513160395
Labeler code 51316
Product ID 51316-395_a91197de-5b20-42c9-928a-b6b1c2084373
Type HUMAN OTC DRUG
Nonproprietary name Magnesium sulfate
Dosage form GRANULE
Route ORAL; TOPICAL
Labeler CVS PHARMACY, INC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-01
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DE08037SAB 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 51316-395-04 Epsom Salt 1810 g in 1 POUCH GRANULE 1810 5 51316-395-08 Epsom Salt 3630 g in 1 POUCH GRANULE 3630 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-395 EPSOM SALT (MAGNESIUM SULFATE) GRANULE [CVS PHARMACY, INC] 4 Current NDC, 2 package rows 20250302_1f9e72dc-a394-420d-8fe8-fc4d0f6906ed.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 Sample Exclude flag Status 51316-395-04 51316039504 1810 g in 1 POUCH (51316-395-04) 1810 g 2023-05-01 No No Current 51316-395-08 51316039508 3630 g in 1 POUCH (51316-395-08) 3630 g 2023-05-01 No No Current