Leader Nasal Decongestant Spray
NDC Package 70000-0665-1

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

Package Information

Leader Nasal Decongestant (oxymetazoline hydrochloride) sprays is before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. This formulation utilizes a spray delivery system. Marketed by Cardinal Health 110,inc, this product is identified by NDC 70000-0665 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
70000-0665-1
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
70000-0665
11-Digit Billing Format
70000066501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leader Nasal Decongestant
Non-Proprietary Name
Oxymetazoline Hydrochloride
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
Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.Wipe nozzle clean after use.Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.Children under 6 years of age consult a doctor.

Regulatory & Marketing

Labeler Name
Cardinal Health 110,inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-31-2024
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 70000-0665-1 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Leader Nasal Decongestant, a human over the counter drug labeled by Cardinal Health 110,inc. 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 Cardinal Health 110,inc on March 31, 2024. The current certification is valid through December 31, 2026.

How is this Cardinal Health 110,inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000066501. 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 (5-4-1)
70000-0665-1
11-Digit CMS (5-4-2)
70000-0665-01

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