Gracie Square Hospital Amenity Kit
NDC Package 59448-101-00

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

Package Information

Gracie Square Hospital Amenity (sodium monofluorophosphate) kits is adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician. This formulation utilizes a kit delivery system. Marketed by Asp Global, Llc, this product is identified by NDC 59448-101 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
59448-101-00
Package Description
1 KIT in 1 BAG * 59 mL in 1 TUBE * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45)
Product Code
59448-101
11-Digit Billing Format
59448010100
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
Gracie Square Hospital Amenity
Non-Proprietary Name
Sodium Monofluorophosphate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician

Regulatory & Marketing

Labeler Name
Asp Global, Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-18-2016
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 59448-101-00 identifies a specific commercial package of 1 kit in 1 bag * 59 ml in 1 tube * 4.25 g in 1 tube * 59 ml in 1 tube * 65 ml in 1 bottle, plastic * 59 ml in 1 tube * 10 g in 1 tube (42555-060-45) of Gracie Square Hospital Amenity, a human over the counter drug labeled by Asp Global, Llc. This kit is formulated for use and contains 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 Asp Global, Llc on January 18, 2016. The current certification is valid through December 31, 2026.

How is this Asp Global, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59448010100. 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)
59448-101-00
11-Digit CMS (5-4-2)
59448-0101-00

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