Prescription and over-the-counter medicine
Levocetirizine Brand names: Xyzal
Levocetirizine (Xyzal) is a prescription and over-the-counter medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 53 generic labelers, and pharmacies paid $0.0511 per levocetirizine 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the levocetirizine FDA label on DailyMed (effective March 11, 2026, Chattem, Inc.); the NDA 22064 record on Drugs@FDA; every levocetirizine label on DailyMed.
Highlights of the record
FDA label of March 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Forms and strengths
- 5 mg
- 0.5 mg/ml
- 2.5 mg/5ml
Tablet; film-coated tablet; coated tablet; solution.
On the market
- Earliest approval on file
- May 25, 2007 Xyzal, Chattem Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first November 26, 2010; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 54 of which 53 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 16, 2027 Xyzal Allergy 24Hr oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0511 per tablet Levocetirizine 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest November 11, 2020
- FAERS reports
- 23,887 through July 30, 2026
What is levocetirizine used for?
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Conditions named in the indications of levocetirizine's FDA labels, with every medicine labeled for each:
From other levocetirizine labelsAllergies: The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Xyzal Allergy 24HR), Chattem, Inc., effective March 11, 2026 (SPL set 8be45c2a-1eca-4a00-81b9-f7babdbdcd41), via openFDA; the full label on DailyMed
Is there a generic for levocetirizine (Xyzal)?
The FDA approved the first generic levocetirizine on November 26, 2010. 24 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists levocetirizine from 53 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Xyzal Allergy 24Hr tablets; a patent listed only for Xyzal Allergy 24Hr oral solution runs to October 16, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2010 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levocetirizine (Xyzal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0511 per Levocetirizine 5 mg tablet, down 8% from $0.0557 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Levocetirizine 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| 24hr allergy(levocetirzn) 5 mg | Generic | $0.218 per unit | n/a | +19% |
| Gnp allergy relief 5 mg tablet | Generic | $0.218 per tablet | $6.55 | +19% |
| Levocetirizine 2.5 mg/5 mL solution | Generic | $0.166 per mL | n/a | -2% |
| Levocetirizine 5 mg tablet | Generic | $0.0511 per tablet | $1.53 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has levocetirizine been recalled?
The FDA's Enforcement Report lists 1 recall naming levocetirizine since 2020: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 11, 2020 | Class III | InvaTech Pharma Solutions, LLC | Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levocetirizine label say about other medicines?
The levocetirizine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name levocetirizine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azithromycin | drug interactions (prescription label) | Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. |
| Cetirizine | contraindications (prescription label) | Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine |
| Cimetidine | drug interactions (prescription label) | Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. |
| Erythromycin | drug interactions (prescription label) | Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. |
| Ketoconazole | drug interactions (prescription label) | Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. |
| Pseudoephedrine | drug interactions (prescription label) | Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. |
| Ritonavir | drug interactions (prescription label) | Ritonavir increased the plasma AUC of cetirizine by about 42% accompanied by an increase in half-life (53%) and a decrease in clearance (29%) of cetirizine. |
| Theophylline | drug interactions (prescription label) | There was a small decrease (~16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline. |
Other labels that name levocetirizine
Source: FDA drug label (Xyzal Allergy 24HR), Chattem, Inc., effective March 11, 2026 (SPL set 8be45c2a-1eca-4a00-81b9-f7babdbdcd41), via openFDA; the full label on DailyMed
What do FAERS reports show for levocetirizine?
The FDA Adverse Event Reporting System holds 23,887 reports that list levocetirizine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 987 are coded as a death and 3,992 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as levocetirizine?
11 other medicines are given the same way (oral) and in the same FDA class as levocetirizine or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diphenhydramine | Allergies | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Cetirizine | Allergies | 164 labelers | $0.0613 per tablet 10 mg tablet | No current entry |
| Fexofenadine | Allergies | 110 labelers | $0.230 per tablet 180 mg tablet | No current entry |
| Chlorpheniramine | Allergies | 2 labelers | $0.0177 per tablet 4 mg tablet | No current entry |
| Desloratadine | Allergies | 9 labelers | $0.258 per tablet 5 mg tablet | No current entry |
| Carbinoxamine | Allergies | 7 labelers | $0.398 per tablet 4 mg tablet | No current entry |
| Chlorpheniramine and ibuprofen and phenylephrine | Allergies | none listed | n/a | No current entry |
| Chlorpheniramine and ibuprofen and pseudoephedrine | Allergies | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as levocetirizine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does levocetirizine compare with medicines for the same use?
7 side-by-side pages set levocetirizine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to levocetirizine
- 11 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Levocetirizine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other