Childrens Zyrtec Allergy Syrup
NDC Package 50580-721-05

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

Package Information

Childrens Zyrtec Allergy (cetirizine hydrochloride) syrups is use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. This formulation utilizes a syrup delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-721 and is authorized under FDA application NDA022155.

Identification & Billing

NDC Package Code
50580-721-05
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
50580-721
11-Digit Billing Format
50580072105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Zyrtec Allergy
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 5 mg/5mL
Pharmacologic Class
Usage Information
Use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
NDA022155
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-20-2009
Listing Expiration
12-31-2027
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 50580-721-05 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Childrens Zyrtec Allergy, a human over the counter drug labeled by Kenvue Brands Llc. This syrup is formulated for oral use and contains cetirizine 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 Kenvue Brands Llc on January 20, 2009. The current certification is valid through December 31, 2027.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580072105. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50580-721-05
11-Digit CMS (5-4-2)
50580-0721-05

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