Eye Drops
NDC Package 0498-0161-15

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.

Eye Drops is tetrahydrozoline is a decongestant used to relieve redness in the eyes caused by minor eye irritations (e.g., smog, swimming, dust, or smoke). Marketed by Honeywell Safety Products Usa, Inc, this product is identified by NDC 0498-0161 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
0498-0161-15
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code
0498-0161
11-Digit Billing Format
00498016115
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eye Drops
Dosage Form
-
Usage Information
Tetrahydrozoline is a decongestant used to relieve redness in the eyes caused by minor eye irritations (e.g., smog, swimming, dust, or smoke). It belongs to a class of drugs known as sympathomimetic amines. It works by temporarily narrowing the blood vessels in the eye. Some brands of tetrahydrozoline eye drops may contain lubricants. Lubricants help protect the eyes from more irritation and dryness.

Regulatory & Marketing

Labeler Name
Honeywell Safety Products Usa, Inc
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-04-2018
Listing Expiration
12-31-2025
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 0498-0161-15 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Eye Drops, labeled by Honeywell Safety Products Usa, Inc. 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 Honeywell Safety Products Usa, Inc on July 04, 2018. The current certification is valid through December 31, 2025.

What are the primary indications for this medication?

Tetrahydrozoline is a decongestant used to relieve redness in the eyes caused by minor eye irritations (e.g., smog, swimming, dust, or smoke). It belongs to a class of drugs known as sympathomimetic amines. It works by temporarily narrowing the blood vessels in the eye. Some brands of tetrahydrozoline eye drops may contain lubricants. Lubricants help protect the eyes from more irritation and dryness.

How is this Honeywell Safety Products Usa, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00498016115. 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)
0498-0161-15
11-Digit CMS (5-4-2)
00498-0161-15

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