Toothette Oral Care Single Use System With Antiseptic Oral Rinse
NDC Package 53462-120-60

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.

Toothette Oral Care Single Use System With Antiseptic Oral Rinse is before opening, turn package over, burst solution packet with thumbs.Peel lid to open.Clean teeth and oral cavity for approximately one minute.Instruct to expectorate.Repeat cleaning with other swab as needed.Discard after use.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. Marketed by Sage Products Llc, this product is identified by NDC 53462-120 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
53462-120-60
Package Description
1 KIT in 1 KIT * 1 PACKET in 1 PACKAGE / 2 POUCH in 1 PACKET / 7 mL in 1 POUCH
Product Code
53462-120
11-Digit Billing Format
53462012060
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Toothette Oral Care Single Use System With Antiseptic Oral Rinse
Dosage Form
-
Usage Information
Before opening, turn package over, burst solution packet with thumbs.Peel lid to open.Clean teeth and oral cavity for approximately one minute.Instruct to expectorate.Repeat cleaning with other swab as needed.Discard after use.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity.

Regulatory & Marketing

Labeler Name
Sage Products Llc
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
03-31-2013
Listing Expiration
12-31-2017
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 53462-120-60 identifies a specific commercial package of 1 kit in 1 kit * 1 packet in 1 package / 2 pouch in 1 packet / 7 ml in 1 pouch of Toothette Oral Care Single Use System With Antiseptic Oral Rinse, labeled by Sage Products 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 Sage Products Llc on March 31, 2013. The current certification is valid through December 31, 2017.

How is this Sage Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462012060. 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)
53462-120-60
11-Digit CMS (5-4-2)
53462-0120-60

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