Halodine Nasal Antiseptic
NDC Package 78371-101-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 applicationGently blow nose to clear both nostrils. Marketed by Halodine Llc, this product is identified by NDC 78371-101 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
78371-101-01
Package Description
96 AMPULE in 1 CARTON / 1.5 mL in 1 AMPULE
Product Code
78371-101
11-Digit Billing Format
78371010101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Halodine Nasal Antiseptic
Dosage Form
-
Usage Information
For nasal applicationGently blow nose to clear both nostrils. Discard tissue.Open single ampoule by tearing off the narrow end along line. To avoid spill while opening, only hold flat foil around raised body of ampoule and maintain ampoule with narrow end pointing up.Place narrow end of ampoule at right nostril and gently pinch left nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through right nostril. Discard ampoule.Open second ampoule by tearing off the narrow end along line. Avoid spill.Place narrow end of ampoule at left nostril and gently pinch right nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through left nostril. Discard ampoule.Note: Do not blow nose. If solution drips, wipe with tissue.

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
05-15-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78371-101). Click a package code to view its specific billing and regulatory data.

78371-101-02
100 AMPULE in 1 CARTON / 1.5 mL in 1 AMPULE
78371-101-03
12 AMPULE in 1 CARTON / 1.5 mL in 1 AMPULE

* 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 78371-101-01 identifies a specific commercial package of 96 ampule in 1 carton / 1.5 ml in 1 ampule 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 May 15, 2020. 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: 78371010101. 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)
78371-101-01
11-Digit CMS (5-4-2)
78371-0101-01

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