Lidocaine 4 Percent And Menthol 1 Percent Roll-on
NDC Package 50488-6541-1

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lidocaine 4 Percent And Menthol 1 Percent Roll-on is  adults and children 2 years and older apply externally to the affected area up to 3 to 4  times a day children under 2 years do not use except under the advice and supervision of a physician. Marketed by Alexso, Inc, this product is identified by NDC 50488-6541 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
50488-6541-1
Package Description
50 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
50488-6541
11-Digit Billing Format
50488654101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk
  • RxCUI: 252967 - lidocaine 4 % / menthol 1 % Topical Solution
  • RxCUI: 252967 - lidocaine 40 MG/ML / menthol 10 MG/ML Topical Solution

Clinical Specifications

Proprietary Name
Lidocaine 4 Percent And Menthol 1 Percent Roll-on
Dosage Form
-
Usage Information
 adults and children 2 years and older apply externally to the affected area up to 3 to 4  times a day children under 2 years do not use except under the advice and supervision of a physician

Regulatory & Marketing

Labeler Name
Alexso, Inc
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
02-17-2021
Listing Expiration
12-31-2023
Exclude Flag
I
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 50488-6541-1 identifies a specific commercial package of 50 ml in 1 bottle, with applicator of Lidocaine 4 Percent And Menthol 1 Percent Roll-on, labeled by Alexso, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 50 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Alexso, Inc on February 17, 2021. The current certification is valid through December 31, 2023.

How is this Alexso, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50488654101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 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 (5-4-1)
50488-6541-1
11-Digit CMS (5-4-2)
50488-6541-01

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