Kids Kare Paste, Dentifrice
NDC Package 59883-718-04

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

Package Information

Kids Kare (sodium fluoride) pastes is adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.Children under 2 years of age: Consult a dentist or doctor.Do not swallow.To minimize swallowing, use a pea-sized amount in children under 6.Instruct children under 6 years of age in good brushing and rinsing habits.Supervise children as necessary until capable of using without supervision. This formulation utilizes a paste, dentifrice delivery system. Marketed by Den-mat Holdings, Llc., this product is identified by NDC 59883-718 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
59883-718-04
Package Description
113.4 g in 1 TUBE
Product Code
59883-718
11-Digit Billing Format
59883071804
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kids Kare
Non-Proprietary Name
Sodium Fluoride
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.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE 2.4 mg/g
Usage Information
Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.Children under 2 years of age: Consult a dentist or doctor.Do not swallow.To minimize swallowing, use a pea-sized amount in children under 6.Instruct children under 6 years of age in good brushing and rinsing habits.Supervise children as necessary until capable of using without supervision.

Regulatory & Marketing

Labeler Name
Den-mat Holdings, Llc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-26-2017
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 59883-718-04 identifies a specific commercial package of 113.4 g in 1 tube of Kids Kare, a human over the counter drug labeled by Den-mat Holdings, Llc.. This paste, dentifrice is formulated for dental; oral 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 Den-mat Holdings, Llc. on October 26, 2017. The current certification is valid through December 31, 2026.

How is this Den-mat Holdings, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59883071804. 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)
59883-718-04
11-Digit CMS (5-4-2)
59883-0718-04

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