Dometuss
NDC Package 53809-202-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dometuss is do not exceed more than 6 doses in any 24-hour periodAdults and children 12 years of age and overTake 1 teaspoonful (5 mL) every 4 hoursChildren 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL) every 4 hoursChildren under 6 years of ageAsk a doctor. Marketed by Domel Laboratories, this product is identified by NDC 53809-202 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
53809-202-04
Package Description
118 mL in 1 BOTTLE
Product Code
53809-202
11-Digit Billing Format
53809020204
RxNorm Crosswalk
  • RxCUI: 1489310 - chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1489310 - chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1489310 - chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Dometuss
Dosage Form
-
Usage Information
Do not exceed more than 6 doses in any 24-hour periodAdults and children 12 years of age and overTake 1 teaspoonful (5 mL) every 4 hoursChildren 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL) every 4 hoursChildren under 6 years of ageAsk a doctor

Regulatory & Marketing

Labeler Name
Domel Laboratories
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-01-2015
Listing Expiration
12-31-2024
Exclude Flag
I
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 53809-202-04 identifies a specific commercial package of 118 ml in 1 bottle of Dometuss, labeled by Domel Laboratories. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Domel Laboratories on August 01, 2015. The current certification is valid through December 31, 2024.

How is this Domel Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53809020204. 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)
53809-202-04
11-Digit CMS (5-4-2)
53809-0202-04

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