Lidothol Patch
NDC Package 80425-0385-1

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

Package Information

Lidothol (lidocaine and menthol) patches is lidothol is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. This formulation utilizes a patch delivery system. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0385.

Identification & Billing

NDC Package Code
80425-0385-1
Package Description
3 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8500 mg in 1 PATCH
Product Code
80425-0385
11-Digit Billing Format
80425038501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lidothol
Non-Proprietary Name
Lidocaine And Menthol
Substance Name
Lidocaine; Menthol
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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 is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact.Other uses may be considered if deemed clinically relevant.

Regulatory & Marketing

Labeler Name
Advanced Rx Pharmacy Of Tennessee, Llc
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
05-10-2024
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 80425-0385-1 identifies a specific commercial package of 3 pouch in 1 box / 5 patch in 1 pouch / 8500 mg in 1 patch of Lidothol, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This patch is formulated for topical use and contains lidocaine; 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 Advanced Rx Pharmacy Of Tennessee, Llc on May 10, 2024. The current certification is valid through December 31, 2026.

How is this Advanced Rx Pharmacy Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425038501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
80425-0385-1
11-Digit CMS (5-4-2)
80425-0385-01

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