Throat Coat Lozenge
NDC Package 78732-002-01

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

Package Information

Throat Coat (menthol) lozenges is adults and children 12 years and over: Dissolve lozenge slowly in the mouth. This formulation utilizes a lozenge delivery system. Marketed by Traditional Medicinals, Inc., this product is identified by NDC 78732-002 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
78732-002-01
Package Description
16 PACKAGE in 1 POUCH / 4.2 g in 1 PACKAGE
Product Code
78732-002
11-Digit Billing Format
78732000201

Clinical Specifications

Proprietary Name
Throat Coat Eucalyptus Mint
Non-Proprietary Name
Menthol
Substance Name
Menthol, Unspecified Form
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MENTHOL, UNSPECIFIED FORM 6 mg/4.2g
Usage Information
Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day Children under 12 years of age: ask a doctor.

Regulatory & Marketing

Labeler Name
Traditional Medicinals, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-04-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78732-002). Click a package code to view its specific billing and regulatory data.

78732-002-00
2 PACKAGE in 1 POUCH / 4.2 g in 1 PACKAGE
78732-002-30
30 PACKAGE in 1 POUCH / 4.2 g in 1 PACKAGE

* 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 78732-002-01 identifies a specific commercial package of 16 package in 1 pouch / 4.2 g in 1 package of Throat Coat Eucalyptus Mint, a human over the counter drug labeled by Traditional Medicinals, Inc.. This lozenge is formulated for oral use and contains menthol, unspecified form 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 Traditional Medicinals, Inc. on June 04, 2020. The current certification is valid through December 31, 2026.

How is this Traditional Medicinals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78732000201. 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)
78732-002-01
11-Digit CMS (5-4-2)
78732-0002-01

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