Lidothol Gel
NDC Package 76420-253-04

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

Package Information

Lidothol (lidocaine hcl, menthol) gel is lidothol Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. This formulation utilizes a gel delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-253.

Identification & Billing

NDC Package Code
76420-253-04
Package Description
1 TUBE in 1 BOX / 99.2 g in 1 TUBE
Product Code
76420-253
11-Digit Billing Format
76420025304
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
99.2 GM

Clinical Specifications

Proprietary Name
Lidothol
Non-Proprietary Name
Lidocaine Hcl, Menthol
Substance Name
Lidocaine Hydrochloride; 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)
Pharmacologic Class
Usage Information
Lidothol Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-01-2019
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 76420-253-04 identifies a specific commercial package of 1 tube in 1 box / 99.2 g in 1 tube of Lidothol, a human prescription drug labeled by Asclemed Usa, Inc.. This product is billed per "GM" gram and contains an estimated amount of 99.2 billable units per package. This gel is formulated for topical use and contains lidocaine hydrochloride; 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 Asclemed Usa, Inc. on April 01, 2019. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420025304. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 99.2 total billable units per package. 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)
76420-253-04
11-Digit CMS (5-4-2)
76420-0253-04

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