Robitussin Maximum Strength Severe Cough Plus Sore Throat Liquid
NDC Package 0031-8750-18

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 Severe Cough Plus Sore Throat (acetaminophen, dextromethorphan hydrobromide) liquids is do not take more than 6 doses in any 24-hour perioddo not exceed recommended dosage. This formulation utilizes a liquid delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-8750 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0031-8750-18
Package Description
1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
Product Code
0031-8750
11-Digit Billing Format
00031875018
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1919076 - acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution
  • RxCUI: 1919076 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
  • RxCUI: 1919076 - acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution
  • RxCUI: 1919076 - acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Solution
  • RxCUI: 1919076 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Robitussin Maximum Strength Severe Cough Plus Sore Throat
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide
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 take more than 6 doses in any 24-hour perioddo not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.measure only with dosing cup providedkeep dosing cup with productml = milliliterthis adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over20 ml every 4 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
04-10-2017
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 (0031-8750). Click a package code to view its specific billing and regulatory data.

0031-8750-12
1 BOTTLE in 1 CARTON / 118 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 0031-8750-18 identifies a specific commercial package of 1 bottle in 1 carton / 237 ml in 1 bottle of Robitussin Maximum Strength Severe Cough Plus Sore Throat, a human over the counter drug labeled by Haleon Us Holdings Llc. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide 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 April 10, 2017. 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: 00031875018. 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)
0031-8750-18
11-Digit CMS (5-4-2)
00031-8750-18

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