Freshenup Fluoride Double Mint
NDC Package 52553-049-02

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.

Freshenup Fluoride Double Mint is adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physicianchildren under 6 yearsto minimize swallowing use a pea sized amount and supervise brushing until good habits are establishedchildren under 2 yearsask a dentist or physician. Marketed by U. S. Nonwovens Corp, this product is identified by NDC 52553-049 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
52553-049-02
Package Description
1 TUBE in 1 CARTON / 99.2 g in 1 TUBE
Product Code
52553-049
11-Digit Billing Format
52553004902
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Freshenup Fluoride Double Mint
Dosage Form
-
Usage Information
Adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physicianchildren under 6 yearsto minimize swallowing use a pea sized amount and supervise brushing until good habits are establishedchildren under 2 yearsask a dentist or physician

Regulatory & Marketing

Labeler Name
U. S. Nonwovens Corp
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
08-14-2019
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 52553-049-02 identifies a specific commercial package of 1 tube in 1 carton / 99.2 g in 1 tube of Freshenup Fluoride Double Mint, labeled by U. S. Nonwovens Corp. 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 U. S. Nonwovens Corp on August 14, 2019. The current certification is valid through December 31, 2022.

How is this U. S. Nonwovens Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52553004902. 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)
52553-049-02
11-Digit CMS (5-4-2)
52553-0049-02

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