Englewood Mesh Amenity Kit
NDC Package 59448-401-00

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

Package Information

Englewood Mesh Amenity (benzalkonium chloride and sodium monofluorophosphate) kits is rub dime sized amount between hands until dry.Children under 6 years of age should be supervised when using this product. This formulation utilizes a kit delivery system. Marketed by Asp Global, Llc, this product is identified by NDC 59448-401 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
59448-401-00
Package Description
20 BAG in 1 BOX / 1 KIT in 1 BAG * 65 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-002-01) * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE
Product Code
59448-401
11-Digit Billing Format
59448040100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Englewood Mesh Amenity
Non-Proprietary Name
Benzalkonium Chloride And Sodium Monofluorophosphate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Rub dime sized amount between hands until dry.Children under 6 years of age should be supervised when using this product. 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 #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-13-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 59448 - Asp Global, Llc
    • 59448-401 - Englewood Mesh Amenity
      • 59448-401-00 - 20 BAG in 1 BOX / 1 KIT in 1 BAG * 65 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-002-01) * 14 g in 1 BOTTLE, WITH APPLICATOR * 59 mL in 1 TUBE * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE

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 59448-401-00 identifies a specific commercial package of 20 bag in 1 box / 1 kit in 1 bag * 65 ml in 1 bottle, plastic * 10 g in 1 tube (42555-060-45) * 53 ml in 1 bottle, plastic (59448-002-01) * 14 g in 1 bottle, with applicator * 59 ml in 1 tube * 4.25 g in 1 tube * 59 ml in 1 tube * 59 ml in 1 tube of Englewood Mesh 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 June 13, 2018. 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: 59448040100. 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)
59448-401-00
11-Digit CMS (5-4-2)
59448-0401-00

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