Tartar Control Plus Antiseptic Mouthwash
NDC Package 11344-855-86

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

Package Information

Tartar Control Plus Antiseptic (eucalyptol, menthol, methyl salicylate, thymol) mouthwashes is adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow {the rinse}children 6 years to under 12 years of age - supervise usechildren under 6 years of age - do not usethis rinse is not intended to replace brushing or flossing. This formulation utilizes a mouthwash delivery system. Marketed by Nice-pak Products, Llc, this product is identified by NDC 11344-855 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
11344-855-86
Package Description
1000 mL in 1 BOTTLE, PLASTIC
Product Code
11344-855
11-Digit Billing Format
11344085586
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
Tartar Control Plus Antiseptic
Non-Proprietary Name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Substance Name
Eucalyptol; Menthol; Methyl Salicylate; Thymol
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow {the rinse}children 6 years to under 12 years of age - supervise usechildren under 6 years of age - do not usethis rinse is not intended to replace brushing or flossing

Regulatory & Marketing

Labeler Name
Nice-pak Products, Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2024
Listing Expiration
12-31-2027
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 11344-855-86 identifies a specific commercial package of 1000 ml in 1 bottle, plastic of Tartar Control Plus Antiseptic, a human over the counter drug labeled by Nice-pak Products, Llc. This mouthwash is formulated for oral use and contains eucalyptol; menthol; 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 Nice-pak Products, Llc on May 01, 2024. The current certification is valid through December 31, 2027.

How is this Nice-pak Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11344085586. 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)
11344-855-86
11-Digit CMS (5-4-2)
11344-0855-86

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