Home NDC 57237-314 Milk of Magnesia
Product NDC 57237-314
11-digit product format 572370314
Labeler code 57237
Product ID 57237-314_bd43f44b-9295-4a99-9c18-18bb52b67887
Type HUMAN OTC DRUG
Nonproprietary name magnesium hydroxide
Dosage form SUSPENSION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M007.58
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-05
Substance MAGNESIUM HYDROXIDE
Active strength 2400 mg/30mL
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 Additional Listing Data#
Finished product Yes
Brand name base Milk of Magnesia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM HYDROXIDE 2400 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NBZ3QY004S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 253017 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 57237-314-03 Milk of Magnesia 30 mL in 1 CUP, UNIT-DOSE SUSPENSION 30 3 57237-314-31 Milk of Magnesia 100 in 1 BOX, UNIT-DOSE SUSPENSION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-314 MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 2 package rows 20241013_dfede6bd-df37-4f0f-9944-49dc13c967de.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 1 of 1 · 1 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 57237-314-03 57237031403 30 mL in 1 CUP, UNIT-DOSE 30 ml Historical 57237-314-31 57237031431 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-314-31) / 30 mL in 1 CUP, UNIT-DOSE (57237-314-03) 2023-07-05 No No Current