Dextromethorphan Hbr. And Guaifenesin Solution
NDC Package 57237-313-18

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

Package Information

Dextromethorphan Hbr. And Guaifenesin solution is a medication used as Cough SuppressantExpectorant. This formulation utilizes a solution delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-313 and is authorized under FDA application M012.85.

Identification & Billing

NDC Package Code
57237-313-18
Package Description
80 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE (57237-313-01)
Product Code
57237-313
11-Digit Billing Format
57237031318
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Dextromethorphan Hbr. And Guaifenesin
Non-Proprietary Name
Dextromethorphan Hbr. And Guaifenesin
Substance Name
Dextromethorphan Hydrobromide; 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)
Pharmacologic Class
Usage Information
This product is used as Cough SuppressantExpectorant. •   temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold•   helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Otc Drug
FDA Application #
M012.85
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-12-2023
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 57237-313-18 identifies a specific commercial package of 80 cup, unit-dose in 1 box, unit-dose / 10 ml in 1 cup, unit-dose (57237-313-01) of Dextromethorphan Hbr. And Guaifenesin, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. This solution is formulated for oral use and contains dextromethorphan hydrobromide; 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 June 12, 2023. The current certification is valid through December 31, 2026.

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: 57237031318. 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 (5-3-2)
57237-313-18
11-Digit CMS (5-4-2)
57237-0313-18

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