Auvon Pain Relief Roll-on Solution
NDC Package 83391-003-01

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

Auvon Pain Relief Roll-on (menthol) solution is rub a thin film over the affected area not more than 3 to 4 times dailyWash hands after use. This formulation utilizes a solution delivery system. Marketed by Shenzhen Yuwen E-commerce Co., Ltd., this product is identified by NDC 83391-003 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83391-003-01
Package Description
1 BOTTLE in 1 PACKAGE / 74 mL in 1 BOTTLE
Product Code
83391-003
11-Digit Billing Format
83391000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Auvon Pain Relief Roll-on
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
MENTHOL 4 g/100mL
Usage Information
Rub a thin film over the affected area not more than 3 to 4 times dailyWash hands after use

Regulatory & Marketing

Labeler Name
Shenzhen Yuwen E-commerce Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-21-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83391-003). Click a package code to view its specific billing and regulatory data.

83391-003-02
2 BOTTLE in 1 PACKAGE / 74 mL in 1 BOTTLE
83391-003-03
3 BOTTLE in 1 PACKAGE / 74 mL in 1 BOTTLE

* 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 83391-003-01 identifies a specific commercial package of 1 bottle in 1 package / 74 ml in 1 bottle of Auvon Pain Relief Roll-on, a human over the counter drug labeled by Shenzhen Yuwen E-commerce Co., Ltd.. This solution is formulated for topical use and contains 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 Shenzhen Yuwen E-commerce Co., Ltd. on September 21, 2024. The current certification is valid through December 31, 2026.

How is this Shenzhen Yuwen E-commerce Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83391000301. 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)
83391-003-01
11-Digit CMS (5-4-2)
83391-0003-01

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