Mucus Relief Er Tablet, Extended Release
NDC Package 55154-4153-0

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

Package Information

Mucus Relief Er (guaifenesin) tablets is a medication used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This formulation utilizes a tablet, extended release delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-4153 and is authorized under FDA application ANDA207342.

Identification & Billing

NDC Package Code
55154-4153-0
Package Description
10 BLISTER PACK in 1 BAG / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
55154-4153
11-Digit Billing Format
55154415300
RxNorm Crosswalk
  • RxCUI: 636522 - guaiFENesin 600 MG 12HR Extended Release Oral Tablet
  • RxCUI: 636522 - 12 HR guaifenesin 600 MG Extended Release Oral Tablet
  • RxCUI: 636522 - guaifenesin 600 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Mucus Relief Er
Non-Proprietary Name
Guaifenesin
Substance Name
Guaifenesin
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUAIFENESIN 600 mg/1
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
Cardinal Health 107, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA207342
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2018
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 55154-4153-0 identifies a specific commercial package of 10 blister pack in 1 bag / 1 tablet, extended release in 1 blister pack of Mucus Relief Er, a human over the counter drug labeled by Cardinal Health 107, Llc. This tablet, extended release 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 Cardinal Health 107, Llc on September 30, 2018. The current certification is valid through December 31, 2027.

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 Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154415300. 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)
55154-4153-0
11-Digit CMS (5-4-2)
55154-4153-00

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