4 Pack
NDC Package 72164-101-04

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.

4 Pack is adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Marketed by Smiletwice, Inc., this product is identified by NDC 72164-101 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
72164-101-04
Package Description
1 KIT in 1 KIT * 2 TUBE in 1 BOX / 96 g in 1 TUBE (72164-000-01) * 2 TUBE in 1 BOX / 96 g in 1 TUBE (72164-001-01)
Product Code
72164-101
11-Digit Billing Format
72164010104
RxNorm Crosswalk
  • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste
  • RxCUI: 1038929 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste

Clinical Specifications

Proprietary Name
4 Pack
Dosage Form
-
Usage Information
Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor. Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Smiletwice, Inc.
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-14-2018
Listing Expiration
12-31-2024
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 72164-101-04 identifies a specific commercial package of 1 kit in 1 kit * 2 tube in 1 box / 96 g in 1 tube (72164-000-01) * 2 tube in 1 box / 96 g in 1 tube (72164-001-01) of 4 Pack, labeled by Smiletwice, Inc.. 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 Smiletwice, Inc. on September 14, 2018. The current certification is valid through December 31, 2024.

How is this Smiletwice, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72164010104. 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)
72164-101-04
11-Digit CMS (5-4-2)
72164-0101-04

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