Careone Allergy Relief
NDC Package 41520-443-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Careone Allergy Relief is read insert (inside package) on how to:•get a new bottle ready (primed) before first use•prime bottle again if not used for more than 2 weeks•use the spray•clean the spray nozzleADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children 12 years of age and older•once daily, spray 2 times into each nostril while sniffing gently•once your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 2 TO UNDER 12 YEARS OF AGE•the growth rate of some children may be slower while using this product. Marketed by American Sales Company, this product is identified by NDC 41520-443 and is authorized under FDA application ANDA078104.

Identification & Billing

NDC Package Code
41520-443-01
Package Description
1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE
Product Code
41520-443
11-Digit Billing Format
41520044301

Clinical Specifications

Proprietary Name
Careone Allergy Relief
Dosage Form
-
Usage Information
Read insert (inside package) on how to:•get a new bottle ready (primed) before first use•prime bottle again if not used for more than 2 weeks•use the spray•clean the spray nozzleADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERadults and children 12 years of age and older•once daily, spray 2 times into each nostril while sniffing gently•once your allergy symptoms improve, reduce to 1 spray in each nostril per dayCHILDREN 2 TO UNDER 12 YEARS OF AGE•the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.children 6 to under 12 years of age•an adult should supervise use•once daily, spray 1 time into each nostril while sniffing gently•if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.children 2 to under 6 years of age•an adult should supervise use•once daily, spray 1 time into each nostril while sniffing gentlychildren under 2 years of age•do not use ● do not use more than directed ● if you forget a dose, do not double the next dose ● do not spray into eyes or mouth ● if allergy symptoms do not improve after one week, stop using and talk to a doctor ● do not use for the common cold ● shake well before each use

Regulatory & Marketing

Labeler Name
American Sales Company
FDA Application #
ANDA078104
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2017
End Marketing Date
05-01-2026
Listing Expiration
05-01-2026
Exclude Flag
D
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 41520-443-01 identifies a specific commercial package of 1 bottle in 1 carton / 120 spray, metered in 1 bottle of Careone Allergy Relief, labeled by American Sales Company. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by American Sales Company on June 12, 2017. The current certification is valid through May 01, 2026.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520044301. 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)
41520-443-01
11-Digit CMS (5-4-2)
41520-0443-01

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