Thera Plus Cold Therapy Pain Relieving Menthol Gel
NDC Package 80684-101-00

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

Package Information

Thera Plus Cold Therapy Pain Relieving Menthol (menthol) gel is adults and children 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physicianwash hands after use with cool water. This formulation utilizes a gel delivery system. Marketed by Fourstar Group Usa, Inc., this product is identified by NDC 80684-101 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
80684-101-00
Package Description
74 mL in 1 BOTTLE
Product Code
80684-101
11-Digit Billing Format
80684010100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thera Plus Cold Therapy Pain Relieving Menthol
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
MENTHOL 40 mg/mL
Usage Information
Adults and children 2 years of age and older; rub a thin film over affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physicianwash hands after use with cool water

Regulatory & Marketing

Labeler Name
Fourstar Group Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2024
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 80684-101-00 identifies a specific commercial package of 74 ml in 1 bottle of Thera Plus Cold Therapy Pain Relieving Menthol, a human over the counter drug labeled by Fourstar Group Usa, Inc.. This gel is formulated for topical use and contains menthol 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 Fourstar Group Usa, Inc. on February 01, 2024. The current certification is valid through December 31, 2026.

How is this Fourstar Group Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80684010100. 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)
80684-101-00
11-Digit CMS (5-4-2)
80684-0101-00

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