Cough Drops Pastille
NDC Package 50804-591-01

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

Package Information

Cough Drops (simply cherry cough drops) 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 Perrigo Direct, Inc., this product is identified by NDC 50804-591 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50804-591-01
Package Description
30 PASTILLE in 1 BAG
Product Code
50804-591
11-Digit Billing Format
50804059101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
RxCUI: 476973 - menthol 5.8 MG Oral Lozenge

Clinical Specifications

Proprietary Name
Cough Drops
Non-Proprietary Name
Simply Cherry Cough Drops
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
Perrigo Direct, 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 50804-591-01 identifies a specific commercial package of 30 pastille in 1 bag of Cough Drops, a human over the counter drug labeled by Perrigo Direct, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Perrigo Direct, Inc. on May 12, 2023. The current certification is valid through December 31, 2026.

How is this Perrigo Direct, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50804059101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
50804-591-01
11-Digit CMS (5-4-2)
50804-0591-01

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