Halodine Nasal Antiseptic
NDC Package 78371-501-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Halodine Nasal Antiseptic is for nasal application to skin inside of nostrils in adults and children 3 years of age and older:1. Marketed by Halodine Llc, this product is identified by NDC 78371-501 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
78371-501-01
Package Description
1 BOTTLE, SPRAY in 1 BOX / 15 mL in 1 BOTTLE, SPRAY
Product Code
78371-501
11-Digit Billing Format
78371050101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Halodine Nasal Antiseptic
Dosage Form
-
Usage Information
For nasal application to skin inside of nostrils in adults and children 3 years of age and older:1. Gently blow nose to clear both nostrils. Discard tissue.2. Remove cap.3. Close one nostril and put only the tip of spray nozzle in other nostril. Aim slightly away from center of nose.4. While sniffing gently, press down the spray nozzle twice. You'll feel a light mist in your nose. Breathe out through your mouth. 5. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap.Children under 3 years of age: Consult a doctor.

Regulatory & Marketing

Labeler Name
Halodine Llc
FDA Application #
part333E
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
02-01-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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 78371-501-01 identifies a specific commercial package of 1 bottle, spray in 1 box / 15 ml in 1 bottle, spray of Halodine Nasal Antiseptic, labeled by Halodine Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Halodine Llc on February 01, 2021. The current certification is valid through December 31, 2022.

How is this Halodine Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78371050101. 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 (5-3-2)
78371-501-01
11-Digit CMS (5-4-2)
78371-0501-01

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