Home NDC 28595-710 Mag 440
Product NDC 28595-710
11-digit product format 285950710
Labeler code 28595
Product ID 28595-710_32fd7e5e-f1bd-85e9-e063-6294a90a876f
Type HUMAN OTC DRUG
Nonproprietary name Megnesium Oxide
Dosage form TABLET
Route ORAL
Labeler Allegis Pharmaceuticals, LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-27
Substance MAGNESIUM OXIDE
Active strength 440 mg/1
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 2026-12-31
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 Mag 440
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM OXIDE 440 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3A3U0GI71G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2707337 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 28595-710-40 Mag 440 40 in 1 BOTTLE TABLET 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28595-710 MAG 440 (MEGNESIUM OXIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC] 3 Current NDC, 1 package rows 20250418_2cb19dc0-115b-38b8-e063-6294a90a4aea.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 19 of 36 · 719 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 28595-710-40 28595071040 40 TABLET in 1 BOTTLE (28595-710-40) 40 tablet 2025-01-27 No No Current