Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime Liquid
NDC Package 0031-0101-04

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

Package Information

Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime (acetaminophen, diphenhydramine hcl) liquids is usestemporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies: cough due to minor throat and bronchial irritationheadachesore throatminor aches and painsrunny nosesneezingitchy, watery eyesitching of the nose or throattemporarily relieves your cough to help you resttemporarily reduces fever. This formulation utilizes a liquid delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-0101 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0031-0101-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
0031-0101
11-Digit Billing Format
00031010104
RxNorm Crosswalk
  • RxCUI: 2374554 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 20 mL Oral Solution
  • RxCUI: 2374554 - acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 2374554 - acetaminophen 650 MG / diphenhydramine HCl 25 MG per 20 mL Oral Solution
  • RxCUI: 2374554 - APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hcl
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride
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
Usestemporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies: cough due to minor throat and bronchial irritationheadachesore throatminor aches and painsrunny nosesneezingitchy, watery eyesitching of the nose or throattemporarily relieves your cough to help you resttemporarily reduces fever

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-15-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0031-0101-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Robitussin Maximum Strength Severe Multi-symptom Cough Cold Flu Nighttime, a human over the counter drug labeled by Haleon Us Holdings Llc. This liquid is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride 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 February 15, 2024. 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: 00031010104. 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)
0031-0101-04
11-Digit CMS (5-4-2)
00031-0101-04

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