Cough Relief Syrup
NDC Package 53499-6864-4

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

Package Information

Cough Relief syrups is a medication used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This formulation utilizes a syrup delivery system. Marketed by Schwabe North America, Inc., this product is identified by NDC 53499-6864.

Identification & Billing

NDC Package Code
53499-6864-4
Package Description
1 BOTTLE in 1 BOX / 120 mL in 1 BOTTLE
Product Code
53499-6864
11-Digit Billing Format
53499686404
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root
Non-Proprietary Name
Cough Relief
Substance Name
Aconitum Napellus; Bryonia Alba Root; Calcium Sulfide; Pelargonium Sidoides Root; Spongia Officinalis Skeleton, Roasted; Tin
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Regulatory & Marketing

Labeler Name
Schwabe North America, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
01-19-2024
Listing Expiration
12-31-2027
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 53499-6864-4 identifies a specific commercial package of 1 bottle in 1 box / 120 ml in 1 bottle of Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root, a human over the counter drug labeled by Schwabe North America, Inc.. This syrup is formulated for oral use and contains aconitum napellus; bryonia alba root; calcium sulfide; pelargonium sidoides root; spongia officinalis skeleton, roasted; tin 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 Schwabe North America, Inc. on January 19, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How is this Schwabe North America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53499686404. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
53499-6864-4
11-Digit CMS (5-4-2)
53499-6864-04

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