Dentalclean Regenerator Sensitive Kids Paste, Dentifrice
NDC Package 84035-005-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dentalclean Regenerator Sensitive Kids (sodium fluoride 0.24%) pastes is useaids in the prevention of dental cavities. This formulation utilizes a paste, dentifrice delivery system. Marketed by Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda, this product is identified by NDC 84035-005 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84035-005-03
Package Description
1 TUBE in 1 CARTON / 104 g in 1 TUBE
Product Code
84035-005
11-Digit Billing Format
84035000503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dentalclean Regenerator Sensitive Kids
Non-Proprietary Name
Sodium Fluoride 0.24%
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 2.4 mg/g
Usage Information
Useaids in the prevention of dental cavities

Regulatory & Marketing

Labeler Name
Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 84035-005-03 identifies a specific commercial package of 1 tube in 1 carton / 104 g in 1 tube of Dentalclean Regenerator Sensitive Kids, a human over the counter drug labeled by Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda. This paste, dentifrice is formulated for dental use and contains sodium fluoride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda on June 01, 2024. The current certification is valid through December 31, 2026.

How is this Rabbit Ind�stria E Com�rcio De Produtos De Higiene Pessoal Ltda product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84035000503. 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)
84035-005-03
11-Digit CMS (5-4-2)
84035-0005-03

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