Giant Eagle Wintermint With Fluoride
NDC Package 63148-021-33

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.

Giant Eagle Wintermint With Fluoride is adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. Marketed by Apollo Health And Beauty Care Inc., this product is identified by NDC 63148-021 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
63148-021-33
Package Description
1000 mL in 1 BOTTLE, PLASTIC
Product Code
63148-021
11-Digit Billing Format
63148002133
RxNorm Crosswalk
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse
  • RxCUI: 313029 - sodium fluoride 0.2 MG/ML Mouthwash
  • RxCUI: 313029 - sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse

Clinical Specifications

Proprietary Name
Giant Eagle Wintermint With Fluoride
Dosage Form
-
Usage Information
Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute then spit out. Do not swallow the rinse. Do not eat or dring for 30 mins after rinsing.Instruct children 12 years of age in good rinsing habits (to minimize swallowing).Supervise children as necessary until capable of using without supervision.Children under 6 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Apollo Health And Beauty Care Inc.
FDA Application #
part355
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-21-2019
Listing Expiration
12-31-2020
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 63148-021-33 identifies a specific commercial package of 1000 ml in 1 bottle, plastic of Giant Eagle Wintermint With Fluoride, labeled by Apollo Health And Beauty Care Inc.. 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 Apollo Health And Beauty Care Inc. on October 21, 2019. The current certification is valid through December 31, 2020.

How is this Apollo Health And Beauty Care Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63148002133. 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)
63148-021-33
11-Digit CMS (5-4-2)
63148-0021-33

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