Home NDC 62372-541 Mylanta Vanilla Caramel
Product NDC 62372-541
11-digit product format 623720541
Labeler code 62372
Product ID 62372-541_10a66d74-74b5-3f8d-e063-6394a90a7f00
Type HUMAN OTC DRUG
Nonproprietary name Calcium carbonate, magnesium hydroxide, simethicone
Dosage form LIQUID
Route ORAL
Labeler Infirst Healthcare Inc.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-31
Substance CALCIUM CARBONATE; DIMETHICONE; MAGNESIUM HYDROXIDE
Active strength 800; 80; 270 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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 Vanilla Caramel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 800 mg/10mL DIMETHICONE 80 mg/10mL MAGNESIUM HYDROXIDE 270 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup 92RU3N3Y1O Internal UNII lookup 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 1788932 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 62372-541-12 Mylanta Vanilla Caramel 355 mL in 1 BOTTLE LIQUID 355 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62372-541 MYLANTA VANILLA CARAMEL (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [INFIRST HEALTHCARE INC.] 1 Current NDC, 1 package rows 20240207_10a66d74-74b4-3f8d-e063-6394a90a7f00.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 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 62372-541-12 62372054112 355 mL in 1 BOTTLE (62372-541-12) 355 ml 2024-01-31 No No Current