Plaque Refresh Remineralizing Rinse Fresh Mint
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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Plaque Refresh Remineralizing Rinse Fresh Mint 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. 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

Clinical Specifications

Proprietary Name
Plaque Refresh Remineralizing Rinse Fresh Mint
Dosage Form
-
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
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2022
End Marketing Date
09-09-2026
Listing Expiration
09-09-2026
Exclude Flag
D
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, labeled by Tja Health Llc. 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 Tja Health Llc on January 01, 2022. The current certification is valid through September 09, 2026.

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.