Cough Drops Pastille
NDC Package 83455-201-01

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

Package Information

Cough Drops (menthol) pastilles is uses temporarily relieves:cough as may occur with a coldocassional minor irritation and sore throat. This formulation utilizes a pastille delivery system. Marketed by United Natural Foods, Inc., this product is identified by NDC 83455-201 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
83455-201-01
Package Description
200 PASTILLE in 1 BAG
Product Code
83455-201
11-Digit Billing Format
83455020101
RxNorm Crosswalk
RxCUI: 476973 - menthol 5.8 MG Oral Lozenge

Clinical Specifications

Proprietary Name
Cough Drops
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Pastille - An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MENTHOL 5.8 mg/1
Usage Information
Uses temporarily relieves:cough as may occur with a coldocassional minor irritation and sore throat

Regulatory & Marketing

Labeler Name
United Natural Foods, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-12-2023
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 83455-201-01 identifies a specific commercial package of 200 pastille in 1 bag of Cough Drops, a human over the counter drug labeled by United Natural Foods, Inc.. This pastille is formulated for oral use and contains menthol 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 United Natural Foods, Inc. on May 12, 2023. The current certification is valid through December 31, 2026.

How is this United Natural Foods, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83455020101. 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)
83455-201-01
11-Digit CMS (5-4-2)
83455-0201-01

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