Short Term Oral Care System
NDC Package 53462-024-30

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.

Short Term Oral Care System is use up to 4 times daily or as directed by a dentist or doctor.Adults and children 3 years and over: rinse mouth for approx. Marketed by Sage Products Llc, this product is identified by NDC 53462-024 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
53462-024-30
Package Description
1 KIT in 1 KIT * 1 BOTTLE, PLASTIC in 1 KIT / 44 mL in 1 BOTTLE, PLASTIC (53462-075-30) * 1 TUBE in 1 KIT / 14 g in 1 TUBE * 1 TUBE in 1 KIT / 9 g in 1 TUBE
Product Code
53462-024
11-Digit Billing Format
53462002430
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Short Term Oral Care System
Dosage Form
-
Usage Information
Use up to 4 times daily or as directed by a dentist or doctor.Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.Children under 12 yeras of age: supervise use.Children under 3 years of age: consult a dentist or doctor.

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
10-19-2016
Listing Expiration
12-31-2020
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 53462-024-30 identifies a specific commercial package of 1 kit in 1 kit * 1 bottle, plastic in 1 kit / 44 ml in 1 bottle, plastic (53462-075-30) * 1 tube in 1 kit / 14 g in 1 tube * 1 tube in 1 kit / 9 g in 1 tube of Short Term Oral Care System, 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 October 19, 2016. The current certification is valid through December 31, 2020.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462002430. 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)
53462-024-30
11-Digit CMS (5-4-2)
53462-0024-30

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