Home NDC 62372-504 Mylanta Maximum Strength Vanilla Caramel Flavor
Product NDC 62372-504
11-digit product format 623720504
Labeler code 62372
Product ID 62372-504_0bb0df3b-05ce-5c5b-e063-6394a90ab91a
Type HUMAN OTC DRUG
Nonproprietary name Antacid and Anti Gas Aluminum hydroxide Magnesium hydroxide and Simethicone
Dosage form SUSPENSION
Route ORAL
Labeler Infirst Healthcare Inc.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-03-21
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength 800; 800; 80 mg/10mL; mg/10mL; mg/10mL
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], Skin Barrier Activity [PE], 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 Mylanta Maximum Strength Vanilla Caramel Flavor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALUMINUM HYDROXIDE 800 mg/10mL MAGNESIUM HYDROXIDE 800 mg/10mL DIMETHICONE 80 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QB0T2IUN0 Internal UNII lookup NBZ3QY004S Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237870 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 62372-504-12 Mylanta Maximum Strength Vanilla Caramel Flavor 355 mL in 1 BOTTLE, PLASTIC SUSPENSION 355 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62372-504 MYLANTA MAXIMUM STRENGTH VANILLA CARAMEL FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240111_ace5cae4-3a78-41c3-987d-59ce22dca2ac.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 16 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 62372-504-12 62372050412 355 mL in 1 BOTTLE, PLASTIC (62372-504-12) 355 ml 2016-03-21 0000-00-00 No No Current