Zylotrol Gel
NDC Package 81902-201-04

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

Package Information

Zylotrol (lidocaine hcl 4%, menthol 1%) gel is usesFor the temporary relief of pain. This formulation utilizes a gel delivery system. Marketed by Whitestone Products Llc, this product is identified by NDC 81902-201 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
81902-201-04
Package Description
1 TUBE in 1 BOX / 118.3 g in 1 TUBE
Product Code
81902-201
11-Digit Billing Format
81902020104
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
118.3 GM
RxNorm Crosswalk
  • RxCUI: 1373137 - lidocaine HCl 4 % / menthol 1 % Topical Gel
  • RxCUI: 1373137 - lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel
  • RxCUI: 1373137 - lidocaine hydrochloride 4 % / menthol 1 % Topical Gel

Clinical Specifications

Proprietary Name
Zylotrol
Non-Proprietary Name
Lidocaine Hcl 4%, Menthol 1%
Substance Name
Lidocaine Hydrochloride; Menthol, Unspecified Form
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
UsesFor the temporary relief of pain.

Regulatory & Marketing

Labeler Name
Whitestone Products Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-04-2022
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 81902-201-04 identifies a specific commercial package of 1 tube in 1 box / 118.3 g in 1 tube of Zylotrol, a human over the counter drug labeled by Whitestone Products Llc. This product is billed per "GM" gram and contains an estimated amount of 118.3 billable units per package. This gel is formulated for topical use and contains lidocaine hydrochloride; 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 Whitestone Products Llc on January 04, 2022. The current certification is valid through December 31, 2026.

How is this Whitestone Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81902020104. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 118.3 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)
81902-201-04
11-Digit CMS (5-4-2)
81902-0201-04

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