Menthol Tablet, Extended Release
NDC Package 53967-002-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Menthol tablets is a drug for further processing. This formulation utilizes a tablet, extended release delivery system. Marketed by Formulation Technology Llc, this product is identified by NDC 53967-002.

Identification & Billing

NDC Package Code
53967-002-01
Package Description
14500 TABLET, EXTENDED RELEASE in 1 PAIL
Product Code
53967-002
11-Digit Billing Format
53967000201

Clinical Specifications

Proprietary Name
Menthol
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Active Ingredient(s)
MENTHOL 10 mg/1

Regulatory & Marketing

Labeler Name
Formulation Technology Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
02-16-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 53967-002-01 identifies a specific commercial package of 14500 tablet, extended release in 1 pail of Menthol (UNFINISHED drug), drug for further processing labeled by Formulation Technology Llc. This tablet, extended release is formulated for 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 Formulation Technology Llc on February 16, 2026. The current certification is valid through December 31, 2027.

How is this Formulation Technology Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53967000201. 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)
53967-002-01
11-Digit CMS (5-4-2)
53967-0002-01

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