Leader Pain Relief Patches Patch
NDC Package 70000-0366-1

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

Package Information

Leader Pain Relief Patches (lidocaine) patches is a medication used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). This formulation utilizes a patch delivery system. Marketed by Cardinal Health, 110 Dba Leader, this product is identified by NDC 70000-0366 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
70000-0366-1
Package Description
5 PATCH in 1 CARTON / 9 g in 1 PATCH
Product Code
70000-0366
11-Digit Billing Format
70000036601
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
Leader Pain Relief Patches
Non-Proprietary Name
Lidocaine
Substance Name
Lidocaine
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)
LIDOCAINE 4 g/100g
Pharmacologic Class
Usage Information
This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

Regulatory & Marketing

Labeler Name
Cardinal Health, 110 Dba Leader
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
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 70000-0366-1 identifies a specific commercial package of 5 patch in 1 carton / 9 g in 1 patch of Leader Pain Relief Patches, a human over the counter drug labeled by Cardinal Health, 110 Dba Leader. This patch is formulated for topical use and contains lidocaine 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 Cardinal Health, 110 Dba Leader on April 01, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

How is this Cardinal Health, 110 Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000036601. 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)
70000-0366-1
11-Digit CMS (5-4-2)
70000-0366-01

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