Childrens Xyzal Allergy — Solution

Overview

Brand name

Childrens Xyzal Allergy

Generic name

Levocetirizine dihydrochloride

Dosage form

Solution

Route

Oral

Marketing category

NDA · NDA

Labeler

Chattem, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Levocetirizine Dihydrochloride	2.5 mg/5mL	855172	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Oral

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Histamine H1 Receptor Antagonists [MoA]	MoA	All 136 members
Histamine-1 Receptor Antagonist [EPC]	EPC	All 134 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

209090

Application type

NDA · New Drug Application

Approval date

January 31, 2017

Sponsor

CHATTEM SANOFI

Products on application

1

Submissions recorded

7

Products approved under application 209090.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
209090-001	XYZAL ALLERGY 24HR	SOLUTION		LEVOCETIRIZINE DIHYDROCHLORIDE	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Use code	Submitted
8633194	October 16, 2027	001	No		February 28, 2017

Approval history

Source: Drugs@FDA

Most recent submissions on application 209090.
Type	No.	Action	Status	Date	Review
Supplement	8	Labeling	Approved	August 31, 2026	Standard
Supplement	7	Labeling	Approved	March 5, 2026	Standard
Supplement	6	Manufacturing (CMC)	Approved	July 22, 2025	N/A
Supplement	4	Manufacturing (CMC)	Approved	October 28, 2022	Standard
Supplement	3	Manufacturing (CMC)	Approved	July 13, 2022	N/A
Supplement	2	Labeling	Approved	November 10, 2020	Standard
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	January 31, 2017	Standard

Review documents

0 · Supplement · September 2, 2026
0 · Supplement · September 2, 2026
0 · Supplement · August 14, 2026
0 · Supplement · March 9, 2026
0 · Supplement · July 23, 2025
0 · Supplement · July 23, 2025
0 · Supplement · October 31, 2022
0 · Supplement · October 31, 2022
0 · Supplement · July 14, 2022
0 · Supplement · July 14, 2022
0 · Supplement · April 9, 2021
0 · Supplement · November 12, 2020
0 · Original application · July 20, 2017
0 · Original application · January 31, 2017
0 · Original application · January 31, 2017

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260205). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260205

Indications and Usage

openFDA Drug Labeling

Use s temporarily relieves these symptoms due to hay fever or other respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions ■ use only with enclosed dosing cup adults 65 years of age and older ■ ask a doctor adults and children 12-64 years of age ■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours children 6-11 years of age ■ take 5 mL once daily in the evening ■ do not take more than 5 mL in 24 hours children 2-5 years of age ■ take 2.5 mL once daily in the evening ■ do not take more than 2.5 mL in 24 hours children under 2 years of age ■ do not use consumers with kidney disease ■ do not use Note: mL=milliliters

Warnings

openFDA Drug Labeling

Warnings Do not use ■ if you have kidney disease ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ■ ever had trouble urinating or emptying your bladder When using this product ■ drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ in rare cases, you may experience itching after stopping levocetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if ■ you have trouble urinating or emptying your bladder ■ an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast - feeding: ■ if breast-feeding: not recommended ■ if pregnant: ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use ■ if you have kidney disease ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have ■ ever had trouble urinating or emptying your bladder

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if ■ you have trouble urinating or emptying your bladder ■ an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active i ngredient (in each 5 mL ) Levocetirizine dihydrochloride 2.5 mg

Adverse event reports

Source: openFDA FAERS

23,891

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LEVOCETIRIZINE DIHYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
41167-3533-0	41167-3533	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3533-0) / 148 mL in 1 BOTTLE	January 4, 2024
41167-3533-1	41167-3533	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3533-1) / 295 mL in 1 BOTTLE	January 1, 2026
41167-3535-0	41167-3535	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3535-0) / 148 mL in 1 BOTTLE	February 1, 2023
41167-3535-1	41167-3535	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3535-1) / 296 mL in 1 BOTTLE	April 1, 2023
41167-3533	41167-3533	Chattem, Inc.	—	January 4, 2024
41167-3535	41167-3535	Chattem, Inc.	—	February 1, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.