Mylanta Vanilla Caramel Liquid
NDC Package 62372-541-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Mylanta Vanilla Caramel (calcium carbonate, magnesium hydroxide, simethicone) liquids is • shake well before use • measure with dosing cup provided• adults and children 12 years and over:10 mL-20 mL (1-2 doses) as needed, between meals, at bedtime or as directed by a doctor• do not take more than 60 mL (6 doses) in any 24-hour period• do not use the maximum dosage for more than 2 weeks• children under 12 years: ask a doctor • mL=milliliter. This formulation utilizes a liquid delivery system. Marketed by Infirst Healthcare Inc., this product is identified by NDC 62372-541 and is authorized under FDA application M001.

Identification & Billing

NDC Package Code
62372-541-12
Package Description
355 mL in 1 BOTTLE
Product Code
62372-541
11-Digit Billing Format
62372054112
RxNorm Crosswalk
  • RxCUI: 1788932 - calcium carbonate 800 MG / magnesium hydroxide 270 MG / simethicone 80 MG in 10 mL Oral Suspension
  • RxCUI: 1788932 - calcium carbonate 80 MG/ML / magnesium hydroxide 27 MG/ML / simethicone 8 MG/ML Oral Suspension
  • RxCUI: 1788932 - calcium carbonate 800 MG / magnesium hydroxide 270 MG / simethicone 80 MG per 10 ML Oral Suspension

Clinical Specifications

Proprietary Name
Mylanta Vanilla Caramel
Non-Proprietary Name
Calcium Carbonate, Magnesium Hydroxide, Simethicone
Substance Name
Calcium Carbonate; Dimethicone; Magnesium Hydroxide
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• shake well before use • measure with dosing cup provided• adults and children 12 years and over:10 mL-20 mL (1-2 doses) as needed, between meals, at bedtime or as directed by a doctor• do not take more than 60 mL (6 doses) in any 24-hour period• do not use the maximum dosage for more than 2 weeks• children under 12 years: ask a doctor • mL=milliliter

Regulatory & Marketing

Labeler Name
Infirst Healthcare Inc.
Product Type
Human Otc Drug
FDA Application #
M001
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-31-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62372-541-12 identifies a specific commercial package of 355 ml in 1 bottle of Mylanta Vanilla Caramel, a human over the counter drug labeled by Infirst Healthcare Inc.. This liquid is formulated for oral use and contains calcium carbonate; dimethicone; magnesium hydroxide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Infirst Healthcare Inc. on January 31, 2024. The current certification is valid through December 31, 2026.

How is this Infirst Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62372054112. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
62372-541-12
11-Digit CMS (5-4-2)
62372-0541-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.