Plaque Refresh Remineralizing Rinse Fresh Mint Liquid
NDC Package 57660-003-01

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Plaque Refresh Remineralizing Rinse Fresh Mint (sodium fluoride) liquids is - Adults and children 12 years of age or older: - use twice daily after brushing your teeth - vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out - do not swallow the rinse - do not eat or drink for 30 minutes after rinsing - supervise children as necessary - Children under 12 year of age: consult a dentist or doctor. This formulation utilizes a liquid delivery system. Marketed by Tja Health Llc, this product is identified by NDC 57660-003 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
57660-003-01
Package Description
473 mL in 1 BOTTLE
Product Code
57660-003
11-Digit Billing Format
57660000301
RxNorm Crosswalk
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse
  • RxCUI: 313029 - sodium fluoride 0.2 MG/ML Mouthwash
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse

Clinical Specifications

Proprietary Name
Plaque Refresh Remineralizing Rinse Fresh Mint
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
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
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)
SODIUM FLUORIDE .1 mg/mL
Usage Information
- Adults and children 12 years of age or older: - use twice daily after brushing your teeth - vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out - do not swallow the rinse - do not eat or drink for 30 minutes after rinsing - supervise children as necessary - Children under 12 year of age: consult a dentist or doctor

Regulatory & Marketing

Labeler Name
Tja Health Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2022
End Marketing Date
09-09-2026
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 57660-003-01 identifies a specific commercial package of 473 ml in 1 bottle of Plaque Refresh Remineralizing Rinse Fresh Mint, a human over the counter drug labeled by Tja Health Llc. This liquid is formulated for topical use and contains sodium fluoride 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 Tja Health Llc on January 01, 2022.

How is this Tja Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57660000301. 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)
57660-003-01
11-Digit CMS (5-4-2)
57660-0003-01

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