Xoten-c
NDC Package 64038-944-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Xoten-c is use only as directed Wash hands thoroughly after use to avoid spreading lotion to the eyes or other sensitive areas of the body if applying lotion to the hands, wait 30 minutes before washing hands Adults and children 12 years of age and older:apply to affected area not more than 3-4 times daily Children under 12 years of age: do not use consult a doctor. Marketed by Living Well Pharmacy Inc., this product is identified by NDC 64038-944 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
64038-944-01
Package Description
113.4 g in 1 BOTTLE
Product Code
64038-944
11-Digit Billing Format
64038094401
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
113.4 GM
RxNorm Crosswalk
  • RxCUI: 1119597 - capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical Lotion
  • RxCUI: 1119597 - capsaicin 0.02 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical Lotion
  • RxCUI: 1125493 - XOTEN-C 0.002 % / 10 % / 20 % Topical Lotion
  • RxCUI: 1125493 - capsaicin 0.02 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical Lotion [Xoten-C]
  • RxCUI: 1125493 - Xoten-C (capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % ) Topical Lotion

Clinical Specifications

Proprietary Name
Xoten-c
Dosage Form
-
Usage Information
Use only as directed Wash hands thoroughly after use to avoid spreading lotion to the eyes or other sensitive areas of the body if applying lotion to the hands, wait 30 minutes before washing hands Adults and children 12 years of age and older:apply to affected area not more than 3-4 times daily Children under 12 years of age: do not use consult a doctor

Regulatory & Marketing

Labeler Name
Living Well Pharmacy Inc.
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
08-01-2011
Listing Expiration
12-31-2018
Exclude Flag
I
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 64038-944-01 identifies a specific commercial package of 113.4 g in 1 bottle of Xoten-c, labeled by Living Well Pharmacy Inc.. This product is billed per "GM" gram and contains an estimated amount of 113.4 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Living Well Pharmacy Inc. on August 01, 2011. The current certification is valid through December 31, 2018.

How is this Living Well Pharmacy Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64038094401. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 113.4 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)
64038-944-01
11-Digit CMS (5-4-2)
64038-0944-01

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