Listerine Cool Mint Antiseptic Liquid
NDC Package 67751-216-01

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

Package Information

Listerine Cool Mint Antiseptic (eucalyptol, menthol, unspecified form, methyl salicylate, and thymol) liquids is rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and nightdo not swallow. This formulation utilizes a liquid delivery system. Marketed by Navajo Manufacturing Company Inc., this product is identified by NDC 67751-216 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
67751-216-01
Package Description
1 BOTTLE in 1 BLISTER PACK / 95 mL in 1 BOTTLE
Product Code
67751-216
11-Digit Billing Format
67751021601
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
  • RxCUI: 1043623 - LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash
  • RxCUI: 1043623 - eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]
  • RxCUI: 1043623 - Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash

Clinical Specifications

Proprietary Name
Listerine Cool Mint Antiseptic
Non-Proprietary Name
Eucalyptol, Menthol, Unspecified Form, Methyl Salicylate, And Thymol
Substance Name
Eucalyptol; Menthol, Unspecified Form; Methyl Salicylate; Thymol
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and nightdo not swallow

Regulatory & Marketing

Labeler Name
Navajo Manufacturing Company Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-03-2018
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 67751-216-01 identifies a specific commercial package of 1 bottle in 1 blister pack / 95 ml in 1 bottle of Listerine Cool Mint Antiseptic, a human over the counter drug labeled by Navajo Manufacturing Company Inc.. This liquid is formulated for oral use and contains eucalyptol; menthol, unspecified form; methyl salicylate; thymol 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 Navajo Manufacturing Company Inc. on December 03, 2018. The current certification is valid through December 31, 2026.

How is this Navajo Manufacturing Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67751021601. 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)
67751-216-01
11-Digit CMS (5-4-2)
67751-0216-01

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