Sodium Chlorode Hypertonicity Ophthalmic Solution
NDC Package 0536-1254-94

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

Package Information

Sodium Chlorode Hypertonicity Ophthalmic Solution (sodium chloride) solution is a medication used to treat dryness inside the nose (nasal passages). This formulation utilizes a solution delivery system. Marketed by Rugby Laboratories, this product is identified by NDC 0536-1254 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
0536-1254-94
Package Description
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE
Product Code
0536-1254
11-Digit Billing Format
00536125494
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Chlorode Hypertonicity Ophthalmic Solution
Non-Proprietary Name
Sodium Chloride
Substance Name
Sodium Chloride
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)
SODIUM CHLORIDE 50 mg/mL
Pharmacologic Class
Usage Information
This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

Regulatory & Marketing

Labeler Name
Rugby Laboratories
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-17-2020
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 0536-1254-94 identifies a specific commercial package of 1 bottle in 1 carton / 15 ml in 1 bottle of Sodium Chlorode Hypertonicity Ophthalmic Solution, a human over the counter drug labeled by Rugby Laboratories. This solution is formulated for ophthalmic use and contains sodium chloride 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 Rugby Laboratories on September 17, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

How is this Rugby Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00536125494. 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)
0536-1254-94
11-Digit CMS (5-4-2)
00536-1254-94

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