NDC Package 87053-008-01 Kids Prime Pediatric Dental Group Anticavity For Kids

Sodium Fluoride Ointment Dental - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
87053-008-01
Package Description:
1 TUBE in 1 BOX / 50 g in 1 TUBE
Product Code:
Proprietary Name:
Kids Prime Pediatric Dental Group Anticavity For Kids
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
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. Children 2 to 6 years Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years Ask a dentist or physician
11-Digit NDC Billing Format:
87053000801
Product Type:
Human Otc Drug
Labeler Name:
Prime Tooth Care Llc
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s):
Dental - Administration to a tooth or teeth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
08-31-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
87053-008-001 TUBE in 1 BOX / 25 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 87053-008-01?

The NDC Packaged Code 87053-008-01 is assigned to a package of 1 tube in 1 box / 50 g in 1 tube of Kids Prime Pediatric Dental Group Anticavity For Kids, a human over the counter drug labeled by Prime Tooth Care Llc. The product's dosage form is ointment and is administered via dental form.

Is NDC 87053-008 included in the NDC Directory?

Yes, Kids Prime Pediatric Dental Group Anticavity For Kids with product code 87053-008 is active and included in the NDC Directory. The product was first marketed by Prime Tooth Care Llc on August 31, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 87053-008-01?

The 11-digit format is 87053000801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-287053-008-015-4-287053-0008-01