Mucolyte Liquid
NDC Package 57237-359-12
Package Information
Mucolyte (guaifenesin) liquids is a medication used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This formulation utilizes a liquid delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-359 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 310604 - guaiFENesin 100 MG in 5 mL Oral Solution
- RxCUI: 310604 - guaifenesin 20 MG/ML Oral Solution
- RxCUI: 310604 - guaifenesin 100 MG per 5 ML Oral Solution
- RxCUI: 310604 - guaifenesin 100 MG per 5 ML Oral Syrup
- RxCUI: 310604 - guaifenesin 200 MG per 10 ML Oral Solution
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 57237 - Rising Pharma Holdings, Inc.
- 57237-359 - Mucolyte
- 57237-359-12 - 118 mL in 1 BOTTLE
- 57237-359 - Mucolyte
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (57237-359). Click a package code to view its specific billing and regulatory data.
* 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 57237-359-12 identifies a specific commercial package of 118 ml in 1 bottle of Mucolyte, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. This liquid 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 Rising Pharma Holdings, Inc. on December 22, 2025. 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 Rising Pharma Holdings, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237035912. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.