Lidocaine Menthol Pain Relief Patch
NDC Package 46122-574-21

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

Package Information

Lidocaine Menthol Pain Relief (lidocaine, menthol) patches is clean and dry affected area. This formulation utilizes a patch delivery system. Marketed by Amerisource Bergen, this product is identified by NDC 46122-574 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
46122-574-21
Package Description
5 PATCH in 1 POUCH / 8 g in 1 PATCH
Product Code
46122-574
11-Digit Billing Format
46122057421
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
Lidocaine Menthol Pain Relief
Non-Proprietary Name
Lidocaine, Menthol
Substance Name
Lidocaine; Menthol, Unspecified Form
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
Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky sideof patch to affected area. Use one patch for up to 12 hours. Discard after single use.Children under 12 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Amerisource Bergen
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2018
Listing Expiration
12-31-2027
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 46122-574-21 identifies a specific commercial package of 5 patch in 1 pouch / 8 g in 1 patch of Lidocaine Menthol Pain Relief, a human over the counter drug labeled by Amerisource Bergen. This patch is formulated for topical use and contains lidocaine; 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 Amerisource Bergen on July 01, 2018. The current certification is valid through December 31, 2027.

How is this Amerisource Bergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122057421. 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 (5-3-2)
46122-574-21
11-Digit CMS (5-4-2)
46122-0574-21

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