Theraflu Flu Relief Max Strength Syrup
NDC Package 0067-8205-01

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

Package Information

Theraflu Flu Relief Max Strength (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr) syrups is •do not use more than directed•measure the dose correctly using the enclosed dosing cup•adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist•do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor •children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use •do not use more than directed•measure the dose correctly using the enclosed dosing cup•adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist•do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age Do not use. This formulation utilizes a syrup delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-8205 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-8205-01
Package Description
245.5 mL in 1 BOTTLE
Product Code
0067-8205
11-Digit Billing Format
00067820501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
245.5 ML
RxNorm Crosswalk
  • RxCUI: 1359455 - acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral Solution
  • RxCUI: 1359455 - acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
  • RxCUI: 1359455 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral Solution
  • RxCUI: 1359455 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution
  • RxCUI: 1359455 - APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Theraflu Flu Relief Max Strength Nighttime
Non-Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not use more than directed•measure the dose correctly using the enclosed dosing cup•adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist•do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor •children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use •do not use more than directed•measure the dose correctly using the enclosed dosing cup•adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist•do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age Do 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
06-27-2022
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 0067-8205-01 identifies a specific commercial package of 245.5 ml in 1 bottle of Theraflu Flu Relief Max Strength Nighttime, a human over the counter drug labeled by Haleon Us Holdings Llc. This product is billed per "ML" milliliter and contains an estimated amount of 245.5 billable units per package. This syrup is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; 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 June 27, 2022. 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: 00067820501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 245.5 total billable units per package. 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)
0067-8205-01
11-Digit CMS (5-4-2)
00067-8205-01

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