Signature Care Childrens Allergy Relief
NDC Package 21130-122-02

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

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

Signature Care Childrens Allergy Relief is •read the Quick Start Guide for how to:•prime the bottle•use the spray•clean the spray nozzle•shake gently before each use•use this product only once a day•do not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER•Week 1 – use 2 sprays in each nostril once daily•Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treatyour symptoms•After 6 months of daily use – ask your doctor if you can keep usingCHILDREN 4 TO 11 YEARS OF AGE•the growth rate of some children may be slower while using this product. Marketed by Safeway, this product is identified by NDC 21130-122 and is authorized under FDA application ANDA207957.

Identification & Billing

NDC Package Code
21130-122-02
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
21130-122
11-Digit Billing Format
21130012202

Clinical Specifications

Proprietary Name
Signature Care Childrens Allergy Relief
Dosage Form
-
Usage Information
•read the Quick Start Guide for how to:•prime the bottle•use the spray•clean the spray nozzle•shake gently before each use•use this product only once a day•do not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER•Week 1 – use 2 sprays in each nostril once daily•Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treatyour symptoms•After 6 months of daily use – ask your doctor if you can keep usingCHILDREN 4 TO 11 YEARS OF AGE•the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.•an adult should supervise use•use 1 spray in each nostril once dailyCHILDREN UNDER 4 YEARS OF AGE•do not use

Regulatory & Marketing

Labeler Name
Safeway
FDA Application #
ANDA207957
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-20-2017
End Marketing Date
04-01-2026
Listing Expiration
04-01-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (21130-122). Click a package code to view its specific billing and regulatory data.

21130-122-08
1 BOTTLE, SPRAY in 1 CARTON / 72 SPRAY, METERED 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 21130-122-02 identifies a specific commercial package of 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray of Signature Care Childrens Allergy Relief, labeled by Safeway. 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 Safeway on June 20, 2017. The current certification is valid through April 01, 2026.

How is this Safeway product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130012202. 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)
21130-122-02
11-Digit CMS (5-4-2)
21130-0122-02

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