Prescription and over-the-counter medicine
Cetirizine Brand names: Zyrtec, All, Quzyttir, Allergy, Zerviate; first approved as Zyrtec Hives
Cetirizine (All) is a prescription and over-the-counter medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 149 generic labelers, and pharmacies paid $0.0613 per cetirizine HCl 10 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $7.35 per unit (Zerviate 0.24% eye drop).
- Generic listed
Check it at the source: the cetirizine FDA label on DailyMed (effective August 7, 2026, GLENMARK THERAPEUTICS INC., USA); the NDA 19835 record on Drugs@FDA; every cetirizine label on DailyMed.
Highlights of the record
FDA label of August 7, 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 upper respiratory allergies:
runny nose,
sneezing,
itchy, watery eyes,
itching of the nose or throat
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 25 mg
- 1 mg/ml
- 2.4 mg/ml
- 5 mg/5ml
- 10 mg/ml
Tablet; solution; film-coated tablet; capsule; coated tablet.
On the market
- Earliest approval on file
- December 8, 1995 Zyrtec Hives, Kenvue Brands; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 63 first December 27, 2007; 42 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 163 of which 149 under generic applications, 27 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
- Last listed patent
- January 9, 2033 Zerviate solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0613 per tablet Cetirizine HCl 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 19 since 2012 1 Class I among all firms' recalls; latest June 24, 2026
- FAERS reports
- 171,713 through July 30, 2026
What is cetirizine used for?
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose,
sneezing,
itchy, watery eyes,
itching of the nose or throat
Conditions named in the indications of cetirizine's FDA labels, with every medicine labeled for each:
From other cetirizine labelsAllergies: Cetirizine hydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age.
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Cetirizine HCl), GLENMARK THERAPEUTICS INC., USA, effective August 7, 2026 (SPL set 04b08c52-5390-4cdb-a9e7-fca81fffdc73), via openFDA; the full label on DailyMed
Is there a generic for cetirizine (All)?
The FDA approved the first generic cetirizine on December 27, 2007. 63 generic applications are approved; 42 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cetirizine from 149 labelers under a generic (ANDA) application and from 27 brand labelers. 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 Cetirizine Hydrochloride Allergy capsules; a patent listed only for Zerviate solution/drops runs to January 9, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2007 first generic approved
- 2033 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 cetirizine (All)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0613 per Cetirizine HCl 10 mg tablet, down 11% from $0.0686 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Cetirizine HCl 10 mg tablet (generic)
- Zerviate 0.24% eye drop (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| All day allergy 10 mg tablet | Generic | $0.0613 per tablet | $1.84 | -11% |
| Allergy rlf (cetrzn) 10 mg tablet | Generic | $0.0613 per tablet | $1.84 | -11% |
| Allergy rlf (cetrzn) 5 mg tablet | Generic | $0.0476 per tablet | $1.43 | +1% |
| Cetirizine HCl 1 mg/mL solution | Generic | $0.0366 per mL | n/a | +3% |
| Cetirizine HCl 1 mg/mL syrup | Generic | $0.0223 per mL | n/a | -4% |
| Cetirizine HCl 10 mg chewable tablet | Generic | $2.11 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $63.41 | -7% |
| Cetirizine HCl 10 mg tablet | Generic | $0.0613 per tablet | $1.84 | -11% |
| Cetirizine HCl 5 mg chewable tablet | Generic | $1.99 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $59.76 | -10% |
| Cetirizine HCl 5 mg tablet | Generic | $0.0476 per tablet | $1.43 | +1% |
| Child all day allergy 1 mg/mL | Generic | $0.0379 per mL | n/a | +7% |
| Child allergy relief 1 mg/mL | Generic | $0.0379 per mL | n/a | +7% |
| Child cetirizine HCl 1 mg/mL | Generic | $0.0366 per mL | n/a | +3% |
| Ft ad allergy (cetrzn) 10 mg tablet | Generic | $0.0613 per tablet | $1.84 | -11% |
| Ft allergy (cetrzn) 10 mg tablet | Generic | $0.0613 per tablet | $1.84 | -11% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cetirizine been recalled?
The FDA's Enforcement Report lists 19 recalls naming cetirizine since 2012: 1 Class I (the most serious), 10 Class II, 8 Class III; 4 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 24, 2026 | Class I | JB Chemicals and Pharmaceuticals Ltd | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP … |
| September 12, 2025 | Class III | JB Chemicals and Pharmaceuticals Ltd | Tablet/Capsules Imprinted with Wrong ID |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| October 5, 2021 | Class III | A-S Medication Solutions LLC. | Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| June 5, 2019 | Class II | P & L Developments, LLC | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to … |
| May 21, 2019 | Class II | Torrent Pharma Inc | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| October 19, 2018 | Class II | Taro Pharmaceuticals U.S.A., Inc. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cetirizine label say about other medicines?
The cetirizine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name cetirizine. 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 | DRUG INTERACTIONS No clinically significant drug interactions with oral cetirizine hydrochloride, the active ingredient in QUZYTTIR, have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. |
| Benzalkonium | warnings and precautions (prescription label) | The preservative in ZERVIATE ® , benzalkonium chloride, may be absorbed by soft contact lenses. |
| Erythromycin | drug interactions | DRUG INTERACTIONS No clinically significant drug interactions with oral cetirizine hydrochloride, the active ingredient in QUZYTTIR, have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. |
| Hydroxyzine | warnings | Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine Ask a doctor before useif you have liver or kidney disease. |
| Ketoconazole | drug interactions | DRUG INTERACTIONS No clinically significant drug interactions with oral cetirizine hydrochloride, the active ingredient in QUZYTTIR, have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. |
| Levocetirizine | contraindications | CONTRAINDICATIONS The use of QUZYTTIR is contraindicated in patients with a known hypersensitivity to cetirizine hydrochloride or any of its ingredients, levocetirizine, or hydroxyzine. |
| Pseudoephedrine | drug interactions | DRUG INTERACTIONS No clinically significant drug interactions with oral cetirizine hydrochloride, the active ingredient in QUZYTTIR, have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. |
| Theophylline | drug interactions | DRUG INTERACTIONS No clinically significant drug interactions with oral cetirizine hydrochloride, the active ingredient in QUZYTTIR, have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. |
Source: FDA drug label (Cetirizine HCl), GLENMARK THERAPEUTICS INC., USA, effective August 7, 2026 (SPL set 04b08c52-5390-4cdb-a9e7-fca81fffdc73), via openFDA; the full label on DailyMed
What do FAERS reports show for cetirizine?
The FDA Adverse Event Reporting System holds 171,713 reports that list cetirizine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,154 are coded as a death and 39,923 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 cetirizine?
11 other medicines are given the same way (oral) and in the same FDA class as cetirizine 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 |
| Fexofenadine | Allergies | 110 labelers | $0.230 per tablet 180 mg tablet | No current entry |
| Levocetirizine | Allergies | 53 labelers | $0.0511 per tablet 5 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 cetirizine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cetirizine compare with medicines for the same use?
11 side-by-side pages set cetirizine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cetirizine
- 11 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Cetirizine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other