Mixed Berry Sore Throat Lozenges Lozenge
NDC Package 36800-836-18

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

Package Information

Mixed Berry Sore Throat Lozenges (benzocaine) lozenges is uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throatcough due to minor throat and bronichial irritation as may occur with the common cold. This formulation utilizes a lozenge delivery system. Marketed by Topco Associates, this product is identified by NDC 36800-836 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-836-18
Package Description
18 LOZENGE in 1 BLISTER PACK
Product Code
36800-836
11-Digit Billing Format
36800083618
RxNorm Crosswalk
  • RxCUI: 1039251 - dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral Lozenge
  • RxCUI: 1039251 - benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge

Clinical Specifications

Proprietary Name
Mixed Berry Sore Throat Lozenges
Non-Proprietary Name
Benzocaine
Substance Name
Benzocaine; Dextromethorphan Hydrobromide
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throatcough due to minor throat and bronichial irritation as may occur with the common cold

Regulatory & Marketing

Labeler Name
Topco Associates
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-03-2018
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 36800-836-18 identifies a specific commercial package of 18 lozenge in 1 blister pack of Mixed Berry Sore Throat Lozenges, a human over the counter drug labeled by Topco Associates. This lozenge is formulated for oral use and contains benzocaine; dextromethorphan hydrobromide 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 Topco Associates on August 03, 2018. The current certification is valid through December 31, 2026.

How is this Topco Associates product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800083618. 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)
36800-836-18
11-Digit CMS (5-4-2)
36800-0836-18

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