Theraflu Expressmax Syrup
NDC Package 0067-8129-08

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

Package Information

Theraflu Expressmax (acetaminophen, diphenhydramine hcl, phenylephrine hcl) syrups is •do not use more than directed•measure the dose correctly using the enclosed dosing cup•take every 4 hours in dosing cup provided, while symptoms persist•do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor 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•take every 4 hours in dosing cup provided, while symptoms persist.•do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor 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 0067-8129 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-8129-08
Package Description
245.5 mL in 1 BOTTLE
Product Code
0067-8129
11-Digit Billing Format
00067812908
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: 1113705 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
  • RxCUI: 1113705 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1113705 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1113705 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1113705 - APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Theraflu Expressmax Nighttime Severe Cold And Cough
Non-Proprietary Name
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
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•take every 4 hours in dosing cup provided, while symptoms persist•do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor 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•take every 4 hours in dosing cup provided, while symptoms persist.•do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor 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
07-15-2015
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 0067-8129-08 identifies a specific commercial package of 245.5 ml in 1 bottle of Theraflu Expressmax Nighttime Severe Cold And Cough, a human over the counter drug labeled by Haleon Us Holdings Llc. This syrup is formulated for oral use and contains acetaminophen; diphenhydramine hydrochloride; phenylephrine 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 July 15, 2015. 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: 00067812908. 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)
0067-8129-08
11-Digit CMS (5-4-2)
00067-8129-08

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