Poly Interferent Mouthwas
NDC Package 82005-322-04

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.

Poly Interferent Mouthwas is rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night.Do not swallow. Marketed by Kounter Dfense Biosciences, Inc., this product is identified by NDC 82005-322 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
82005-322-04
Package Description
118 mL in 1 BOTTLE
Product Code
82005-322
11-Digit Billing Format
82005032204
RxNorm Crosswalk
  • RxCUI: 1043619 - eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash
  • RxCUI: 1043619 - eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash

Clinical Specifications

Proprietary Name
Poly Interferent Mouthwas
Dosage Form
-
Usage Information
Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night.Do not swallow

Regulatory & Marketing

Labeler Name
Kounter Dfense Biosciences, Inc.
FDA Application #
part356
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
11-05-2021
Listing Expiration
12-31-2022
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 82005-322-04 identifies a specific commercial package of 118 ml in 1 bottle of Poly Interferent Mouthwas, labeled by Kounter Dfense Biosciences, Inc.. 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 Kounter Dfense Biosciences, Inc. on November 05, 2021. The current certification is valid through December 31, 2022.

How is this Kounter Dfense Biosciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82005032204. 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)
82005-322-04
11-Digit CMS (5-4-2)
82005-0322-04

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