Prescription medicine
Hydroxyzine First approved as Atarax
Hydroxyzine (Atarax) is a prescription medicine with an FDA approval on record since 1956. FDA's NDC Directory lists it from 61 generic labelers, and pharmacies paid $0.0326 per hydroxyzine HCl 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the hydroxyzine FDA label on DailyMed (effective March 3, 2026, Aurobindo Pharma Limited); the NDA 10392 record on Drugs@FDA; every hydroxyzine label on DailyMed.
Highlights of the record
FDA label of March 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFor symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 100 mg
- 10 mg/5ml
- 25 mg/ml
- 50 mg/ml
- 50 mg/25ml
Film-coated tablet; capsule; tablet; solution; injection (solution).
On the market
- Earliest approval on file
- April 12, 1956 Atarax, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 100 first August 24, 1979; 30 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 61 of which 61 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0326 per tablet Hydroxyzine HCl 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 18 since 2012 0 Class I among all firms' recalls; latest June 2, 2026; 4 more by firms not listed as its makers
- FAERS reports
- 50,844 through July 30, 2026
What is hydroxyzine used for?
From the label: indications and usageFor symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. […]
Conditions named in the indications of hydroxyzine's FDA labels, with every medicine labeled for each:
From other hydroxyzine labelsAnxiety: INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Alcohol use disorder: It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and …
FDA pharmacologic class: Antihistamine.
Source: FDA drug label (Hydroxyzine Hydrochloride), Aurobindo Pharma Limited, effective March 3, 2026 (SPL set 9de2de56-614f-4294-8794-d30758cf5f70), via openFDA; the full label on DailyMed
Is there a generic for hydroxyzine (Atarax)?
The FDA approved the first generic hydroxyzine on August 24, 1979. 100 generic applications are approved; 30 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 hydroxyzine from 61 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1956 earliest approval on file
- 1979 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydroxyzine (Atarax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0326 per Hydroxyzine HCl 25 mg tablet, down 12% from $0.0368 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.
- Hydroxyzine HCl 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydroxyzine 10 mg/5 mL solution | Generic | $0.113 per mL | n/a | -30% |
| Hydroxyzine 10 mg/5 mL syrup | Generic | $0.113 per mL | n/a | -30% |
| Hydroxyzine HCl 10 mg tablet | Generic | $0.0287 per tablet | $0.860 | -9% |
| Hydroxyzine HCl 25 mg tablet | Generic | $0.0326 per tablet | $0.977 | -12% |
| Hydroxyzine HCl 50 mg tablet | Generic | $0.0558 per tablet | $1.67 | -15% |
| Hydroxyzine pam 100 mg capsule | Generic | $0.426 per capsule | $12.78 | +2% |
| Hydroxyzine pam 25 mg capsule | Generic | $0.0636 per capsule | $1.91 | -1% |
| Hydroxyzine pam 50 mg capsule | Generic | $0.082 per capsule | $2.46 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has hydroxyzine been recalled?
The FDA's Enforcement Report lists 22 recalls naming hydroxyzine since 2012: 0 Class I (the most serious), 18 Class II, 4 Class III; 1 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of hydroxyzine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 2, 2026 | Class III | ANI Pharmaceuticals, Inc. | Presence of foreign substance |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 9, 2020 | Class II | Morton Grove Pharmaceuticals, Inc. | Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. |
| October 11, 2018 | Class II | Lannett Company, Inc. | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. |
| July 26, 2016 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility |
| June 29, 2015 | Class III | Qualitest Pharmaceuticals | Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable |
| May 18, 2015 | Class II | Advanced Physician Solutions, Inc. not a listed maker | Lack of Assurance of Sterility |
| April 7, 2015 | Class II | Akorn, Inc. | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydroxyzine label say about other medicines?
The hydroxyzine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name hydroxyzine. 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 |
|---|---|---|
| Cetirizine | contraindications | CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. |
| Levocetirizine | contraindications | CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. |
Source: FDA drug label (Hydroxyzine Hydrochloride), Aurobindo Pharma Limited, effective March 3, 2026 (SPL set 9de2de56-614f-4294-8794-d30758cf5f70), via openFDA; the full label on DailyMed
What do FAERS reports show for hydroxyzine?
The FDA Adverse Event Reporting System holds 50,844 reports that list hydroxyzine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,463 are coded as a death and 15,632 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 hydroxyzine?
10 other medicines are given the same way (oral) and in the same FDA class as hydroxyzine or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 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 |
|---|---|---|---|---|
| Buspirone | Anxiety | 49 labelers | $0.043 per tablet 15 mg tablet | No current entry |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Meprobamate | Anxiety | 3 labelers | $5.89 per tablet 400 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydroxyzine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does hydroxyzine compare with medicines for the same use?
10 side-by-side pages set hydroxyzine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to hydroxyzine
- 10 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Hydroxyzine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other