Xyzal Allergy 24HR — Tablet

Overview

Brand name

Xyzal Allergy 24HR

Generic name

Levocetirizine dihydrochloride

Dosage form

Tablet

Route

Oral

Marketing category

NDA · NDA

Labeler

Chattem, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

11

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	5 mg/1	855172	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

14

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

209089

Application type

NDA · New Drug Application

Approval date

January 31, 2017

Sponsor

CHATTEM SANOFI

Products on application

1

Submissions recorded

3

Products approved under application 209089.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
209089-001	XYZAL ALLERGY 24HR	TABLET		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.

Approval history

Source: Drugs@FDA

Most recent submissions on application 209089.
Type	No.	Action	Status	Date	Review
Supplement	10	Labeling	Approved	May 20, 2026	Standard
Supplement	7	Labeling	Approved	July 11, 2024	Standard
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	January 31, 2017	Standard

Review documents

0 · Supplement · May 21, 2026
0 · Supplement · May 21, 2026
0 · Supplement · July 15, 2024
0 · Supplement · July 15, 2024
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 20260311). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260311

Indications and Usage

openFDA Drug Labeling

Uses 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 adults 65 years of age and older ■ ask a doctor adults and children 12-64 years of age ■ take 1 tablet (5 mg) once daily in the evening ■ do not take more than 1 tablet (5 mg) in 24 hours ■ 1⁄2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age ■ take 1⁄2 tablet (2.5 mg) once daily in the evening ■ do not take more than 1⁄2 tablet (2.5 mg) in 24 hours children under 6 years of age ■ do not use consumers with kidney disease ■ do not use

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 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 ingredient (in each tablet) Levocetirizine dihydrochloride 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
41167-3510-0	41167-3510	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-3510-0) / 10 TABLET in 1 BLISTER PACK	March 10, 2017
41167-3510-1	41167-3510	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3510-1) / 35 TABLET in 1 BOTTLE	March 10, 2017
41167-3510-2	41167-3510	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3510-2) / 55 TABLET in 1 BOTTLE	March 10, 2017
41167-3510-3	41167-3510	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3510-3) / 80 TABLET in 1 BOTTLE	March 10, 2017
41167-3510-4	41167-3510	Chattem, Inc.	2 BOTTLE in 1 CARTON (41167-3510-4) / 55 TABLET in 1 BOTTLE	March 10, 2017
41167-3510-5	41167-3510	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-3510-5) / 45 TABLET in 1 BOTTLE	January 4, 2024
41167-3510-6	41167-3510	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-3510-6) / 5 TABLET in 1 BLISTER PACK	November 15, 2018
41167-3511-2	41167-3511	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-3511-2) / 20 TABLET in 1 BLISTER PACK	September 1, 2023
41167-3511-8	41167-3511	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-3511-8) / 40 TABLET in 1 BLISTER PACK	January 1, 2026
41167-3511-9	41167-3511	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-3511-9) / 60 TABLET in 1 BLISTER PACK	January 1, 2026
41167-3513-4	41167-3513	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-3513-4) / 90 TABLET in 1 BLISTER PACK	January 1, 2026
41167-3510	41167-3510	Chattem, Inc.	—	March 10, 2017
41167-3511	41167-3511	Chattem, Inc.	—	September 1, 2023
41167-3513	41167-3513	Chattem, Inc.	—	January 1, 2026

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
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.