Robafen Dm Cough Solution
NDC Package 0904-7441-20

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

Package Information

Robafen Dm Cough (dextromethorphan hbr, guaifenesin) solution is do not take more than directeddo not take more than 6 doses in any 24-hour periodmL = milliliteronly use the dose cup providedadults and children 12 years and over: 20 mL every 4 hourschildren under 12 years: do not use. This formulation utilizes a solution delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-7441 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0904-7441-20
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
0904-7441
11-Digit Billing Format
00904744120
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1790650 - dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution
  • RxCUI: 1790650 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution
  • RxCUI: 1790650 - dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution
  • RxCUI: 1790650 - dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution
  • RxCUI: 1790650 - dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Robafen Dm Cough
Non-Proprietary Name
Dextromethorphan Hbr, 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
Do not take more than directeddo not take more than 6 doses in any 24-hour periodmL = milliliteronly use the dose cup providedadults and children 12 years and over: 20 mL every 4 hourschildren under 12 years: do not use

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-05-2024
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 0904-7441-20 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Robafen Dm Cough, a human over the counter drug labeled by Major Pharmaceuticals. 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 Major Pharmaceuticals on April 05, 2024. The current certification is valid through December 31, 2027.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904744120. 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 (4-4-2)
0904-7441-20
11-Digit CMS (5-4-2)
00904-7441-20

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