Robitussin Maximum Strength Nighttime Cough Dm Solution
NDC Package 0031-8718-18

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

Robitussin Maximum Strength Nighttime Cough Dm (dextromethorphan hydrobromide, doxylamine succinate) solution is measure only with dosing cup providedkeep dosing cup with productml = milliliterdo not take more than 4 doses in any 24-hour periodthis adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over20 ml every 6 hourschildren under 12 yearsdo not use. This formulation utilizes a solution delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-8718 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0031-8718-18
Package Description
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
Product Code
0031-8718
11-Digit Billing Format
00031871818
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1115329 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution
  • RxCUI: 1115329 - dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution
  • RxCUI: 1115329 - dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution
  • RxCUI: 1115329 - dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Robitussin Maximum Strength Nighttime Cough Dm
Non-Proprietary Name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name
Dextromethorphan Hydrobromide; Doxylamine Succinate
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
Measure only with dosing cup providedkeep dosing cup with productml = milliliterdo not take more than 4 doses in any 24-hour periodthis adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over20 ml every 6 hourschildren under 12 yearsdo not use

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2016
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 (0031-8718). Click a package code to view its specific billing and regulatory data.

0031-8718-13
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
0031-8718-24
1 BOTTLE in 1 CARTON / 355 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 0031-8718-18 identifies a specific commercial package of 1 bottle in 1 carton / 237 ml in 1 bottle of Robitussin Maximum Strength Nighttime Cough Dm, a human over the counter drug labeled by Haleon Us Holdings Llc. This solution is formulated for oral use and contains dextromethorphan hydrobromide; doxylamine succinate 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 Haleon Us Holdings Llc on June 01, 2016. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00031871818. 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)
0031-8718-18
11-Digit CMS (5-4-2)
00031-8718-18

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