Guaifenesin And Dextromethorphan Hydrobromide Syrup
NDC Package 58657-504-08

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

Package Information

Guaifenesin And Dextromethorphan Hydrobromide syrups is do not take more than 6 doses in any 24-hour period. This formulation utilizes a syrup delivery system. Marketed by Method Pharmaceuticals, this product is identified by NDC 58657-504 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58657-504-08
Package Description
237 mL in 1 BOTTLE, PLASTIC
Product Code
58657-504
11-Digit Billing Format
58657050408
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML
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
Guaifenesin And Dextromethorphan Hydrobromide
Non-Proprietary Name
Guaifenesin And Dextromethorphan Hydrobromide
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
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)
Pharmacologic Class
Usage Information
Do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of ageadults and children 12 years and over2 teaspoonfuls (TSP) every 4 hourschildren 6 to 12 years of age1 teaspoonful (TSP) every 4 hourschildren under 6 yearsDO NOT USE

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2024
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 58657-504-08 identifies a specific commercial package of 237 ml in 1 bottle, plastic of Guaifenesin And Dextromethorphan Hydrobromide, a human over the counter drug labeled by Method Pharmaceuticals. This syrup 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 Method Pharmaceuticals on April 01, 2024. The current certification is valid through December 31, 2026.

How is this Method Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657050408. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 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:

10-Digit Format (5-3-2)
58657-504-08
11-Digit CMS (5-4-2)
58657-0504-08

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