Cetirizine Hydrochloride Solution
NDC Package 57237-357-12

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

Cetirizine Hydrochloride solution is use with a dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.adults 65 years and over1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children 2 to under 6 years of age½ teaspoonful (2.5 mL) once daily. This formulation utilizes a solution delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-357 and is authorized under FDA application ANDA091327.

Identification & Billing

NDC Package Code
57237-357-12
Package Description
120 mL in 1 BOTTLE, PLASTIC
Product Code
57237-357
11-Digit Billing Format
57237035712
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 1 mg/mL
Pharmacologic Class
Usage Information
Use with a dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.adults 65 years and over1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children 2 to under 6 years of age½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA091327
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2025
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 (57237-357). Click a package code to view its specific billing and regulatory data.

57237-357-24
240 mL in 1 BOTTLE, PLASTIC

* 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 57237-357-12 identifies a specific commercial package of 120 ml in 1 bottle, plastic of Cetirizine Hydrochloride, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 120 billable units per package. This solution 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 Rising Pharma Holdings, Inc. on November 11, 2025. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237035712. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 total billable units per package. 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)
57237-357-12
11-Digit CMS (5-4-2)
57237-0357-12

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