Achelon Lidocaine Patch
NDC Package 84209-400-01

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

Package Information

Achelon Lidocaine Patch (lidocaine patch 4%) 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 Achelon, Inc, this product is identified by NDC 84209-400 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
84209-400-01
Package Description
60.81 cm2 in 1 POUCH
Product Code
84209-400
11-Digit Billing Format
84209040001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Achelon Lidocaine Patch
Non-Proprietary Name
Lidocaine Patch 4%
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.
  • 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
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
Achelon, Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-26-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (84209-400). Click a package code to view its specific billing and regulatory data.

84209-400-03
3 POUCH in 1 BOX / 20.27 cm2 in 1 POUCH

* 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 84209-400-01 identifies a specific commercial package of 60.81 cm2 in 1 pouch of Achelon Lidocaine Patch, a human over the counter drug labeled by Achelon, Inc. 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 Achelon, Inc on March 26, 2025. 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 Achelon, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84209040001. 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)
84209-400-01
11-Digit CMS (5-4-2)
84209-0400-01

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