Theraworx Pain Relief Roll-on With Lidocaine For Diabetics Liquid
NDC Package 61594-030-00

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

Package Information

Theraworx Pain Relief Roll-on With Lidocaine For Diabetics (lidocaine hydrochloride) liquids is adults and children 2 years of age and older: shake bottle well roll a thin layer to each affected area and allow to air dry repeat Wash hands after applying product do not use more than 3 to 4 times daily children under 2 years of age do not use: consult a doctor. This formulation utilizes a liquid delivery system. Marketed by Avadim Holdings, Inc., this product is identified by NDC 61594-030 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
61594-030-00
Package Description
74 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
61594-030
11-Digit Billing Format
61594003000
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
74 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Theraworx Pain Relief Roll-on With Lidocaine For Diabetics
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 HYDROCHLORIDE 40 mg/mL
Pharmacologic Class
Usage Information
Adults and children 2 years of age and older: shake bottle well roll a thin layer to each affected area and allow to air dry repeat Wash hands after applying product do not use more than 3 to 4 times daily children under 2 years of age do not use: consult a doctor

Regulatory & Marketing

Labeler Name
Avadim Holdings, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2024
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 61594-030-00 identifies a specific commercial package of 74 ml in 1 bottle, with applicator of Theraworx Pain Relief Roll-on With Lidocaine For Diabetics, a human over the counter drug labeled by Avadim Holdings, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 74 billable units per package. This liquid is formulated for topical use and contains lidocaine hydrochloride 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 Avadim Holdings, Inc. on June 01, 2024. The current certification is valid through December 31, 2026.

How is this Avadim Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61594003000. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 74 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)
61594-030-00
11-Digit CMS (5-4-2)
61594-0030-00

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