Sinucleanse Sterile Saline Mist Daily Care Spray
NDC Package 42829-504-45

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

Sinucleanse Sterile Saline Mist Daily Care (sodium chloride) sprays is a medication used to treat dryness inside the nose (nasal passages). This formulation utilizes a spray delivery system. Marketed by Ascent Consumer Products, Inc, this product is identified by NDC 42829-504.

Identification & Billing

NDC Package Code
42829-504-45
Package Description
127 g in 1 BOTTLE, SPRAY
Product Code
42829-504
11-Digit Billing Format
42829050445
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sinucleanse Sterile Saline Mist Daily Care
Non-Proprietary Name
Sodium Chloride
Substance Name
Sodium Chloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
SODIUM CHLORIDE .9 g/100g
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
Ascent Consumer Products, Inc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-08-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42829-504). Click a package code to view its specific billing and regulatory data.

42829-504-75
213 g in 1 BOTTLE, SPRAY

* 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 42829-504-45 identifies a specific commercial package of 127 g in 1 bottle, spray of Sinucleanse Sterile Saline Mist Daily Care, a human over the counter drug labeled by Ascent Consumer Products, Inc. This spray is formulated for nasal 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 Ascent Consumer Products, Inc on January 08, 2022. 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 Ascent Consumer Products, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42829050445. 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)
42829-504-45
11-Digit CMS (5-4-2)
42829-0504-45

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