Professional Whitening System Whitening Mouth Wash
NDC Package 62111-0212-4

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.

Professional Whitening System Whitening Mouth Wash is  Adults and children 12 years ofage or older:• use twice daily after brushing yourteeth with a toothpaste• vigorously swish 10 ml (2 teaspoonfuls)of rinse between your teeth for 1 minuteand then spit out• do not swallow the rinse• do not eat or drink for 30 minutesafter rinsing• supervise children as necessary untilcapable of using without supervision• Children under 12 years of age consulta dentist or doctor. Marketed by Akg Innovations Llc, this product is identified by NDC 62111-0212 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
62111-0212-4
Package Description
220 mL in 1 BOTTLE
Product Code
62111-0212
11-Digit Billing Format
62111021204
RxNorm Crosswalk
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse
  • RxCUI: 313029 - sodium fluoride 0.2 MG/ML Mouthwash
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse

Clinical Specifications

Proprietary Name
Professional Whitening System Whitening Mouth Wash
Dosage Form
-
Usage Information
 Adults and children 12 years ofage or older:• use twice daily after brushing yourteeth with a toothpaste• vigorously swish 10 ml (2 teaspoonfuls)of rinse between your teeth for 1 minuteand then spit out• do not swallow the rinse• do not eat or drink for 30 minutesafter rinsing• supervise children as necessary untilcapable of using without supervision• Children under 12 years of age consulta dentist or doctor

Regulatory & Marketing

Labeler Name
Akg Innovations Llc
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-14-2014
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 62111-0212-4 identifies a specific commercial package of 220 ml in 1 bottle of Professional Whitening System Whitening Mouth Wash, labeled by Akg Innovations 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 Akg Innovations Llc on February 14, 2014. The current certification is valid through December 31, 2017.

How is this Akg Innovations Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62111021204. 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)
62111-0212-4
11-Digit CMS (5-4-2)
62111-0212-04

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