Bentasil
NDC Package 63104-003-20

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.

Bentasil is •adults and children 5 years and over: slowly dissolve one drop in the mouth. Marketed by Cloetta Italia S.r.l., this product is identified by NDC 63104-003 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
63104-003-20
Package Description
20 LOZENGE in 1 BAG
Product Code
63104-003
11-Digit Billing Format
63104000320
RxNorm Crosswalk
  • RxCUI: 1537073 - eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge
  • RxCUI: 1537073 - Eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge
  • RxCUI: 1537079 - Bentasil Eucalyptus 5.8 MG / 5.7 MG Oral Lozenge
  • RxCUI: 1537079 - Eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge [Bentasil Eucalyptus]
  • RxCUI: 1537079 - Bentasil Eucalyptus (menthol 5.8 MG / eucalyptus oil 5.7 MG) Oral Lozenge

Clinical Specifications

Proprietary Name
Bentasil Sugar Free Eucalyptus Soft Texture
Dosage Form
-
Usage Information
•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed.  •children under 5 years: ask a doctor

Regulatory & Marketing

Labeler Name
Cloetta Italia S.r.l.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-01-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63104-003-20 identifies a specific commercial package of 20 lozenge in 1 bag of Bentasil Sugar Free Eucalyptus Soft Texture, labeled by Cloetta Italia S.r.l.. 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 Cloetta Italia S.r.l. on April 01, 2014. The current certification is valid through December 31, 2017.

How is this Cloetta Italia S.r.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63104000320. 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)
63104-003-20
11-Digit CMS (5-4-2)
63104-0003-20

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