Home NDC 58657-120 Magnesium Oxide
Product NDC 58657-120
11-digit product format 586570120
Labeler code 58657
Product ID 58657-120_41b54dc8-16af-7ea0-e063-6394a90ad7b2
Type HUMAN OTC DRUG
Nonproprietary name Magnesium Oxide
Dosage form TABLET
Route ORAL
Labeler Method Pharmaceuticals, LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-25
Substance MAGNESIUM OXIDE
Active strength 400 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 Magnesium Oxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM OXIDE 400 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 198741 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 58657-120-12 Magnesium Oxide 120 in 1 BOTTLE TABLET 120 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58657-120 MAGNESIUM OXIDE TABLET [METHOD PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241126_0af63651-f9d9-43b9-b6f0-4878466a82e6.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 8 of 34 · 678 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 58657-120-12 58657012012 120 TABLET in 1 BOTTLE (58657-120-12) 120 tablet 2018-07-25 0000-00-00 No No Current