Level Wintermint Five Whitening Formula Anticavity
NDC Package 50001-121-50

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.

Level Wintermint Five Whitening Formula Anticavity is purposeAnticaries. Marketed by Level Oral Care, Llc, this product is identified by NDC 50001-121 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
50001-121-50
Package Description
141.7 g in 1 TUBE
Product Code
50001-121
11-Digit Billing Format
50001012150
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Level Wintermint Five Whitening Formula Anticavity
Dosage Form
-
Usage Information
PurposeAnticaries

Regulatory & Marketing

Labeler Name
Level Oral Care, Llc
FDA Application #
part356
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-16-2010
Listing Expiration
12-31-2018
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 50001-121-50 identifies a specific commercial package of 141.7 g in 1 tube of Level Wintermint Five Whitening Formula Anticavity, labeled by Level Oral Care, 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 Level Oral Care, Llc on August 16, 2010. The current certification is valid through December 31, 2018.

How is this Level Oral Care, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50001012150. 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)
50001-121-50
11-Digit CMS (5-4-2)
50001-0121-50

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