Robitussin Maximum Strength Nighttime Cough Dm Solution
NDC Package 0031-8718-13
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
- 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
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
Regulatory & Marketing
Hierarchy Structure
- 0031 - Haleon Us Holdings Llc
- 0031-8718 - Robitussin Maximum Strength Nighttime Cough Dm
- 0031-8718-13 - 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
- 0031-8718 - Robitussin Maximum Strength Nighttime Cough Dm
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.
* 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 0031-8718-13 identifies a specific commercial package of 1 bottle in 1 carton / 118 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: 00031871813. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
