Topcare Health Ultra Itch Relief Astringent Eye Drops Solution
NDC Package 36800-855-01

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

Package Information

Topcare Health Ultra Itch Relief Astringent Eye Drops (tetrahydrozoline hcl, zinc sulfate) solution is usefor temporary relief of discomfort and redness of the eye due to minor eye irritations. This formulation utilizes a solution delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-855 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
36800-855-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code
36800-855
11-Digit Billing Format
36800085501
RxNorm Crosswalk
  • RxCUI: 1043249 - tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution
  • RxCUI: 1043249 - tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution
  • RxCUI: 1043249 - Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Topcare Health Ultra Itch Relief Astringent Eye Drops
Non-Proprietary Name
Tetrahydrozoline Hcl, Zinc Sulfate
Substance Name
Tetrahydrozoline Hydrochloride; Zinc Sulfate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Usefor temporary relief of discomfort and redness of the eye due to minor eye irritations

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2020
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 36800-855-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Topcare Health Ultra Itch Relief Astringent Eye Drops, a human over the counter drug labeled by Topco Associates Llc. This solution is formulated for ophthalmic use and contains tetrahydrozoline hydrochloride; zinc sulfate 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 Topco Associates Llc on February 01, 2020. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800085501. 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)
36800-855-01
11-Digit CMS (5-4-2)
36800-0855-01

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