Denblan
NDC Package 16555-996-01

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.

Denblan is adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).Supervise children as neccessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor. Marketed by Darphin Dist., this product is identified by NDC 16555-996 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
16555-996-01
Package Description
1 TUBE in 1 CARTON / 75 mL in 1 TUBE
Product Code
16555-996
11-Digit Billing Format
16555099601
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
Denblan Whitening Formula Anti Cavity Fluoride
Dosage Form
-
Usage Information
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).Supervise children as neccessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Darphin Dist.
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-01-2004
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 16555-996-01 identifies a specific commercial package of 1 tube in 1 carton / 75 ml in 1 tube of Denblan Whitening Formula Anti Cavity Fluoride, labeled by Darphin Dist.. 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 Darphin Dist. on August 01, 2004. The current certification is valid through December 31, 2017.

How is this Darphin Dist. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16555099601. 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)
16555-996-01
11-Digit CMS (5-4-2)
16555-0996-01

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