Oxymetazoline Hydrochloride Spray
NDC Package 63868-607-01

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

Package Information

Oxymetazoline Hydrochloride sprays is adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10-12 hours. This formulation utilizes a spray delivery system. Marketed by Chain Drug Marketing Association Inc., this product is identified by NDC 63868-607 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
63868-607-01
Package Description
30 mL in 1 BOTTLE, SPRAY
Product Code
63868-607
11-Digit Billing Format
63868060701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxymetazoline Hydrochloride
Non-Proprietary Name
Oxymetazoline Hydrochloride
Substance Name
Oxymetazoline Hydrochloride
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)
OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL
Pharmacologic Class
Usage Information
Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period.children under 6 years of age: ask a doctorShake well before use.to spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Regulatory & Marketing

Labeler Name
Chain Drug Marketing Association Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2021
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 63868-607-01 identifies a specific commercial package of 30 ml in 1 bottle, spray of Oxymetazoline Hydrochloride, a human over the counter drug labeled by Chain Drug Marketing Association Inc.. This spray 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 Chain Drug Marketing Association Inc. on February 01, 2021. The current certification is valid through December 31, 2026.

How is this Chain Drug Marketing Association Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868060701. 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)
63868-607-01
11-Digit CMS (5-4-2)
63868-0607-01

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