Winco Original Formula Eye Drops Solution/ Drops
NDC Package 67091-310-15

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

Package Information

Winco Original Formula Eye Drops (tetrahydrozoline hcl) solution/ dropses is tetrahydrozoline is a decongestant used to relieve redness in the eyes caused by minor eye irritations (e.g., smog, swimming, dust, or smoke). This formulation utilizes a solution/ drops delivery system. Marketed by Winco Foods, Llc, this product is identified by NDC 67091-310 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
67091-310-15
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC
Product Code
67091-310
11-Digit Billing Format
67091031015
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Winco Original Formula Eye Drops
Non-Proprietary Name
Tetrahydrozoline Hcl
Substance Name
Tetrahydrozoline Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL
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
Winco Foods, Llc
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-26-2018
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 67091-310-15 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 15 ml in 1 bottle, plastic of Winco Original Formula Eye Drops, a human over the counter drug labeled by Winco Foods, Llc. This solution/ drops is formulated for ophthalmic use and contains tetrahydrozoline 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 Winco Foods, Llc on September 26, 2018. The current certification is valid through December 31, 2026.

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 Winco Foods, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67091031015. 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)
67091-310-15
11-Digit CMS (5-4-2)
67091-0310-15

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