Eyesaline Eyewash Concentrate Liquid
NDC Package 80716-300-01

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

Eyesaline Eyewash Concentrate (purified water) liquids is concentrate must be diluted (1) part concentrate to (10) parts potable water before use• Prepare sufficient quantity of constituted eyewash solution in advance of an emergency. This formulation utilizes a liquid delivery system. Marketed by Protective Industrial Products, Inc., this product is identified by NDC 80716-300 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
80716-300-01
Package Description
2182.9679 g in 1 BOTTLE, PLASTIC
Product Code
80716-300
11-Digit Billing Format
80716030001

Clinical Specifications

Proprietary Name
Eyesaline Eyewash Concentrate
Non-Proprietary Name
Purified Water
Substance Name
Water
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
WATER 92.14 g/100g
Usage Information
Concentrate must be diluted (1) part concentrate to (10) parts potable water before use• Prepare sufficient quantity of constituted eyewash solution in advance of an emergency. • Mix concentrate with potable water to prepare eyewash solution as follows: • Determine quantity of eyewash solution required • Follow sanitary procedures • Wear protective eyewear and gloves • Pour 1/3 of required amount of potable water into mixing container or eyewash unit • Add 1/3 of required amount of concentrate to water • Agitate or mix thoroughly • Repeat until required amount of solution is prepared • Properly dispose of empty bottle after use. • Do not reuse • Keep bottle upright • Replace solution no longer than (6) months after mixing

Regulatory & Marketing

Labeler Name
Protective Industrial Products, Inc.
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-19-2025
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80716-300). Click a package code to view its specific billing and regulatory data.

80716-300-02
5301.4935 g in 1 BOTTLE, PLASTIC

* 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 80716-300-01 identifies a specific commercial package of 2182.9679 g in 1 bottle, plastic of Eyesaline Eyewash Concentrate, a human over the counter drug labeled by Protective Industrial Products, Inc.. This liquid is formulated for ophthalmic use and contains water 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 Protective Industrial Products, Inc. on November 19, 2025. The current certification is valid through December 31, 2027.

How is this Protective Industrial Products, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80716030001. 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)
80716-300-01
11-Digit CMS (5-4-2)
80716-0300-01

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