Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Spray, Metered
NDC Package 11523-0091-2

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

Children Afrin Extra Moisturizing Stuffy Nose Pump Mist (oxymetazoline hydrochloride) sprays is children 2 to under 6 years of age (with adult supervision): 2 or3 sprays in each nostril not more often than every 10 to 12 hours. This formulation utilizes a spray, metered delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 11523-0091 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
11523-0091-2
Package Description
2 BOTTLE, PUMP in 1 CARTON / 15 mL in 1 BOTTLE, PUMP
Product Code
11523-0091
11-Digit Billing Format
11523009102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist
Non-Proprietary Name
Oxymetazoline Hydrochloride
Substance Name
Oxymetazoline Hydrochloride
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
OXYMETAZOLINE HYDROCHLORIDE .025 g/100mL
Pharmacologic Class
Usage Information
Children 2 to under 6 years of age (with adult supervision): 2 or3 sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. children under 2 years of age: consult a doctorTo Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly up to 10 times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke. Wipe nozzle clean after use. Secure cap after use.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-03-2022
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 (11523-0091). Click a package code to view its specific billing and regulatory data.

11523-0091-1
1 BOTTLE, PUMP in 1 CARTON / 15 mL in 1 BOTTLE, PUMP

* 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 11523-0091-2 identifies a specific commercial package of 2 bottle, pump in 1 carton / 15 ml in 1 bottle, pump of Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist, a human over the counter drug labeled by Bayer Healthcare Llc.. This spray, metered 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 Bayer Healthcare Llc. on July 03, 2022. The current certification is valid through December 31, 2026.

How is this Bayer Healthcare Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11523009102. 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 (5-4-1)
11523-0091-2
11-Digit CMS (5-4-2)
11523-0091-02

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