Amerfresh
NDC Package 51460-5000-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amerfresh is adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.Children 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. Marketed by Amercare Products Inc, this product is identified by NDC 51460-5000 and is authorized under FDA application part355.

Identification & Billing

NDC Package Code
51460-5000-2
Package Description
85 g in 1 TUBE
Product Code
51460-5000
11-Digit Billing Format
51460500002
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
Amerfresh
Dosage Form
-
Usage Information
Adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.Children 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
Amercare Products 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
01-01-1996
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51460-5000). Click a package code to view its specific billing and regulatory data.

51460-5000-1
141 g in 1 TUBE
51460-5000-3
42 g in 1 TUBE
51460-5000-4
24 g in 1 TUBE
51460-5000-5
17 g in 1 TUBE
51460-5000-6
4.24 g in 1 POUCH

* 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 51460-5000-2 identifies a specific commercial package of 85 g in 1 tube of Amerfresh, labeled by Amercare Products 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 Amercare Products Inc on January 01, 1996. The current certification is valid through December 31, 2017.

How is this Amercare Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51460500002. 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 (5-4-1)
51460-5000-2
11-Digit CMS (5-4-2)
51460-5000-02

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