Smartmouth
NDC Package 76357-409-16

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 & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Marketed by Triumph Pharmaceuticals Inc., this product is identified by NDC 76357-409 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
76357-409-16
Package Description
1 KIT in 1 CELLO PACK * 237 mL in 1 BOTTLE, PLASTIC * 237 mL in 1 BOTTLE, PLASTIC
Product Code
76357-409
11-Digit Billing Format
76357040916
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Smartmouth Mouth Sore Zinc Activated Formula
Dosage Form
-
Usage Information
Adults and children 12 years of age & older: Swish 20mL of rinse (pour to indicator line on cup) around the mouth over the affected area for at least 1 minute, gargle and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.Children 6 years to under 12 years of age should be supervised in the use of this product.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
01-01-2022
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 76357-409-16 identifies a specific commercial package of 1 kit in 1 cello pack * 237 ml in 1 bottle, plastic * 237 ml in 1 bottle, plastic of Smartmouth Mouth Sore Zinc Activated 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 January 01, 2022. 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: 76357040916. 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)
76357-409-16
11-Digit CMS (5-4-2)
76357-0409-16

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