Dr.whitiss 10%
NDC Package 47649-0101-2

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.

Dr.whitiss 10% is 1. Marketed by Nibec Co., Ltd, this product is identified by NDC 47649-0101 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
47649-0101-2
Package Description
4 SYRINGE in 1 PACKAGE / 1 g in 1 SYRINGE (47649-0101-1)
Product Code
47649-0101
11-Digit Billing Format
47649010102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dr.whitiss 10%
Dosage Form
-
Usage Information
1. Gingival and general oral heath should be confirmed before treatment.2. Brush your teeth before treatment.3. Follow your dentist’s instructions on how to load gel into your custom whitening tray. Use no more than 1/3 to 1/2 of the syringe per tray.4. Insert whitening tray in the mouth over the teeth. Seat the tray firmly agains the teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse twice; do not swallow rinsed gel.)5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for 8-10 hours or overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours, and Dr.Whitiss 35% for 30 minutes.6. If significant sensitivity occurs, stop treatment and consult dentist.

Regulatory & Marketing

Labeler Name
Nibec Co., Ltd
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
06-07-2015
Listing Expiration
12-31-2023
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 47649-0101-2 identifies a specific commercial package of 4 syringe in 1 package / 1 g in 1 syringe (47649-0101-1) of Dr.whitiss 10%, labeled by Nibec Co., Ltd. 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 Nibec Co., Ltd on June 07, 2015. The current certification is valid through December 31, 2023.

How is this Nibec Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47649010102. 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 (5-4-1)
47649-0101-2
11-Digit CMS (5-4-2)
47649-0101-02

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