Smartmouth
NDC Package 76357-210-01

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 inactivated by the FDA.

Smartmouth is adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (pour to indicator line on cap) twice a day for 30 seconds and then spit out. Marketed by Triumph Pharmaceuticals Inc., this product is identified by NDC 76357-210 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
76357-210-01
Package Description
1 KIT in 1 CELLO PACK * 296 mL in 1 BOTTLE, PLASTIC * 296 mL in 1 BOTTLE, PLASTIC (76357-290-01)
Product Code
76357-210
11-Digit Billing Format
76357021001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Smartmouth Clinical Gum And Plaque Formula
Dosage Form
-
Usage Information
Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse (pour to indicator line on cap) twice a day for 30 seconds and then spit out. Do not swallow.Children 6 years to under 12 years of age: supervise use.Children under 6 years of age: do not use.

Regulatory & Marketing

Labeler Name
Triumph Pharmaceuticals Inc.
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-02-2020
Listing Expiration
12-31-2025
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 76357-210-01 identifies a specific commercial package of 1 kit in 1 cello pack * 296 ml in 1 bottle, plastic * 296 ml in 1 bottle, plastic (76357-290-01) of Smartmouth Clinical Gum And Plaque Formula, labeled by Triumph Pharmaceuticals 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 Triumph Pharmaceuticals Inc. on December 02, 2020. The current certification is valid through December 31, 2025.

How is this Triumph Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76357021001. 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)
76357-210-01
11-Digit CMS (5-4-2)
76357-0210-01

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