Dometuss-dm Liquid
NDC Package 53809-201-04

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

Package Information

Dometuss-dm (guaifenesin, dextromethorphan hbr) liquids is do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.   Adults and children 12 years of age and over Take 1 teaspoonful (5 mL) every 6 hours Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) every 6 hours Children under 6 years of age Ask a doctor . This formulation utilizes a liquid delivery system. Marketed by Domel Laboratories, this product is identified by NDC 53809-201 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53809-201-04
Package Description
118 mL in 1 BOTTLE
Product Code
53809-201
11-Digit Billing Format
53809020104
RxNorm Crosswalk
  • RxCUI: 1147924 - dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral Solution
  • RxCUI: 1147924 - dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral Solution
  • RxCUI: 1147924 - dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Dometuss-dm
Non-Proprietary Name
Guaifenesin, Dextromethorphan Hbr
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.   Adults and children 12 years of age and over Take 1 teaspoonful (5 mL) every 6 hours Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) every 6 hours Children under 6 years of age Ask a doctor 

Regulatory & Marketing

Labeler Name
Domel Laboratories
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-21-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53809-201). Click a package code to view its specific billing and regulatory data.

53809-201-01
30 mL in 1 BOTTLE

* 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 53809-201-04 identifies a specific commercial package of 118 ml in 1 bottle of Dometuss-dm, a human over the counter drug labeled by Domel Laboratories. This liquid 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 Domel Laboratories on January 21, 2016. The current certification is valid through December 31, 2026.

How is this Domel Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53809020104. 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)
53809-201-04
11-Digit CMS (5-4-2)
53809-0201-04

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