Theraflu Spray
NDC Package 0067-0109-01

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

Package Information

Theraflu (oxymetazoline hcl) sprays is a medication used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies. This formulation utilizes a spray delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0067-0109 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0067-0109-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 10 mL in 1 BOTTLE, SPRAY
Product Code
0067-0109
11-Digit Billing Format
00067010901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Theraflu Severe Congestion Relief Cooling Nasal Mist
Non-Proprietary Name
Oxymetazoline Hcl
Substance Name
Oxymetazoline Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL
Pharmacologic Class
Usage Information
This medication is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies. It works by narrowing the blood vessels in the nose area, reducing swelling and congestion.

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2025
Listing Expiration
12-31-2027
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 0067-0109-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 10 ml in 1 bottle, spray of Theraflu Severe Congestion Relief Cooling Nasal Mist, a human over the counter drug labeled by Haleon Us Holdings Llc. This spray is formulated for nasal use and contains oxymetazoline 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 June 01, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies. It works by narrowing the blood vessels in the nose area, reducing swelling and congestion.

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: 00067010901. 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)
0067-0109-01
11-Digit CMS (5-4-2)
00067-0109-01

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