Mylanta Maximum Strength Vanilla Caramel Flavor Suspension
NDC Package 62372-504-12

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

Package Information

Mylanta Maximum Strength Vanilla Caramel Flavor (antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone) suspension is  shake well before use measure with dosing cup provided adults and children 12 years and over: 10 mL-20 mL (1-2 doses) 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 suspension delivery system. Marketed by Infirst Healthcare Inc., this product is identified by NDC 62372-504 and is authorized under FDA application M001.

Identification & Billing

NDC Package Code
62372-504-12
Package Description
355 mL in 1 BOTTLE, PLASTIC
Product Code
62372-504
11-Digit Billing Format
62372050412
RxNorm Crosswalk
  • RxCUI: 237870 - aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral Suspension
  • RxCUI: 237870 - aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension
  • RxCUI: 237870 - aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension
  • RxCUI: 237870 - aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension
  • RxCUI: 237870 - aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension

Clinical Specifications

Proprietary Name
Mylanta Maximum Strength Vanilla Caramel Flavor
Non-Proprietary Name
Antacid And Anti Gas Aluminum Hydroxide Magnesium Hydroxide And Simethicone
Substance Name
Aluminum Hydroxide; Dimethicone; Magnesium Hydroxide
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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) 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
03-21-2016
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 62372-504-12 identifies a specific commercial package of 355 ml in 1 bottle, plastic of Mylanta Maximum Strength Vanilla Caramel Flavor, a human over the counter drug labeled by Infirst Healthcare Inc.. This suspension is formulated for oral use and contains aluminum hydroxide; 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 March 21, 2016. 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: 62372050412. 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)
62372-504-12
11-Digit CMS (5-4-2)
62372-0504-12

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