Xlear Nasal Decongestant Liquid
NDC Package 27017-018-01

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

Package Information

Xlear Nasal Decongestant (nasal spray) liquids is shake well before using. This formulation utilizes a liquid delivery system. Marketed by Xlear Inc., this product is identified by NDC 27017-018 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
27017-018-01
Package Description
1 g in 1 BOTTLE, SPRAY
Product Code
27017-018
11-Digit Billing Format
27017001801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xlear Nasal Decongestant
Non-Proprietary Name
Nasal Spray
Substance Name
Oxymetazoline Hydrochloride
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
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
OXYMETAZOLINE HYDROCHLORIDE .0005 g/g
Pharmacologic Class
Usage Information
Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Claer the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostirl and depress pump completely while breathing in through the nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Regulatory & Marketing

Labeler Name
Xlear Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-12-2019
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 27017-018-01 identifies a specific commercial package of 1 g in 1 bottle, spray of Xlear Nasal Decongestant, a human over the counter drug labeled by Xlear Inc.. This liquid is formulated for nasal use and contains oxymetazoline 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 Xlear Inc. on March 12, 2019. The current certification is valid through December 31, 2026.

How is this Xlear Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27017001801. 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)
27017-018-01
11-Digit CMS (5-4-2)
27017-0018-01

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