Childrens Giltuss Ex Expectorant Solution
NDC Package 65852-016-04

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

Package Information

Childrens Giltuss Ex Expectorant (guaifenesin) solution is a medication used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This formulation utilizes a solution delivery system. Marketed by Dextrum Laboratories Inc., this product is identified by NDC 65852-016 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
65852-016-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
65852-016
11-Digit Billing Format
65852001604
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Giltuss Ex Expectorant
Non-Proprietary Name
Guaifenesin
Substance Name
Guaifenesin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUAIFENESIN 200 mg/5mL
Pharmacologic Class
Usage Information
This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 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. To decrease the risk for side effects, carefully follow all dosage directions. 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
Dextrum Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-22-2020
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 65852-016-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Childrens Giltuss Ex Expectorant, a human over the counter drug labeled by Dextrum Laboratories Inc.. This solution is formulated for oral use and contains guaifenesin 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 Dextrum Laboratories Inc. on June 22, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 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. To decrease the risk for side effects, carefully follow all dosage directions. 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 Dextrum Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65852001604. 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)
65852-016-04
11-Digit CMS (5-4-2)
65852-0016-04

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