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Hydroxyzine

Hydroxyzine is a calming antihistamine-type medicine used for anxiety and tension, itchy skin from allergic conditions, and as a sedative before and after anesthesia, with an injectable form for emergencies and surgery-related use.

Brand names VistarilAtaraxHypamOrgatraxHydroxyzine Pamoate
Drug classes Antihistamine
Rx Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 225 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Hydroxyzine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Hydroxyzine is an older antihistamine, on the market since the 1950s and available as a generic, used for anxiety and tension, itching from hives and eczema-type rashes, and sedation before and after anesthesia; it blocks histamine and quiets deeper brain areas, and is a familiar alternative to habit-forming anxiety medicines. Most people tolerate it well; drowsiness and dry mouth are what they notice, and the drowsiness often eases in a few days but gets stronger with alcohol or other sedating drugs. Its rare serious risk is QT prolongation (a dangerous heart rhythm change), so get help right away for a fast or irregular heartbeat or fainting.

Clinical pearls

  • Make sure every prescriber knows you take it, since citalopram, azithromycin, ondansetron and methadone can add to its heart rhythm risk.
  • A rash with fever and small pus-filled bumps can signal AGEP, a serious skin reaction; stop it and call your doctor.
  • If you have ever been allergic to cetirizine (Zyrtec) or levocetirizine (Xyzal), skip hydroxyzine, because they are close chemical cousins.
  • Hydroxyzine is off-limits in early pregnancy and while breastfeeding, a point worth raising before the first dose.
How you get itPrescription only
Comes asTablet, Capsule, Oral solution +1
Earliest FDA record1956
Companies listing it with the FDA54
FDA label last updatedOct 25, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Hydroxyzine, written from its FDA label.

What Hydroxyzine is used for

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Hydroxyzine is used for several purposes, depending on the product.

  • Oral hydroxyzine (tablets, capsules, oral solution and syrup): relief of anxiety and tension associated with psychoneurosis, and anxiety that accompanies organic (physical) disease.
  • Oral hydroxyzine: itching from allergic conditions such as chronic urticaria, atopic and contact dermatoses, and histamine-mediated itching.
  • Oral hydroxyzine: sedation before and after general anesthesia.
  • Hydroxyzine hydrochloride injection (intramuscular): acutely disturbed or hysterical patients.
  • Hydroxyzine hydrochloride injection: alcoholics with anxiety withdrawal symptoms or delirium tremens.
  • Hydroxyzine hydrochloride injection: before and after surgery and childbirth to allay anxiety, control vomiting and reduce narcotic needs.
  • Hydroxyzine hydrochloride injection: nausea and vomiting, excluding that of pregnancy.
  • Hydroxyzine hydrochloride injection: easing anxiety in people with heart disease, and as an add-on in alcoholism and in allergic conditions with strong emotional overlay, such as asthma, chronic urticaria and itching.

How Hydroxyzine works

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Hydroxyzine is chemically unrelated to phenothiazines, reserpine and meprobamate. It calms anxious and tense adults, and anxious, hyperkinetic (overactive) children, without impairing mental alertness. Its calming action may come from suppressing activity in certain deeper regions of the central nervous system.

It also blocks histamine effects, which helps itching, and has antiemetic (anti-vomiting) effects.

Hydroxyzine dosage

▾

Tablets, capsules, oral solution and syrup are taken by mouth, usually a few times a day. The injection is given into a muscle by a healthcare professional. Dosing differs by use and by age or weight in children, and is adjusted to your response.

  • If treatment starts with the injection, later doses may be given by mouth.
  • Follow your prescriber's directions and the product label.

Dosing details from the FDA-approved label

From the Hydroxyzine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult psychiatric and emotional emergencies, including acute alcoholism (intramuscular)
    • 50 to100 mg stat., and every 4 to 6 hours as needed
    • Dosage should be adjusted according to the patient's response to therapy
  • Nausea and vomiting excluding nausea and vomiting of pregnancy (intramuscular)
    • Adults: 25 to 100 mg intramuscularly
    • Children: 0.5 mg/lb body weight intramuscularly
  • Pre- and postoperative adjunctive medication (intramuscular)
    • Adults: 25 to 100 mg intramuscularly
    • Children: 0.5 mg/lb body weight intramuscularly
  • Pre- and postpartum adjunctive therapy (intramuscular)
    • 25 to 100 mg intramuscularly
    • May be administered without further dilution; maintain on oral therapy whenever practicable
  • Anxiety and tension associated with psychoneurosis, adjunct in organic disease states with anxiety (oral) - adults
    • 50 mg to 100 mg four times daily (q.i.d.)
    • Dosage adjusted according to patient's response
  • Anxiety and tension (oral) - children under 6 years
    • 50 mg daily in divided doses
  • Anxiety and tension (oral) - children over 6 years
    • 50 mg to 100 mg daily in divided doses
  • Pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and histamine-mediated pruritus (oral) - adults
    • 25 mg three times daily (t.i.d.) or q.i.d
  • Pruritus (oral) - children under 6 years / over 6 years
    • Under 6 years: 50 mg daily in divided doses
    • Over 6 years: 50 mg to 100 mg daily in divided doses
  • Sedative as premedication and following general anesthesia (oral)
    • 50 mg to 100 mg for adults and 0.6 mg/kg of body weight in children
    • When treatment is initiated by the intramuscular route, subsequent doses may be administered orally
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg four times a day; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg three times a day or four times a day.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

Read the full Dosage and Administration section on DailyMed →

Hydroxyzine side effects

▾

Side effects are usually mild and temporary.

Common side effects

  • Drowsiness (often eases in a few days or with a lower dose)
  • Dry mouth
  • Headache
  • Rash, hives or itching
  • Drowsiness, which often fades within a few days or with a lower dose

When to get medical help

  • Get help right away for a fast or irregular heartbeat, fainting or dizziness, which can signal QT prolongation or Torsade de Pointes (dangerous heart rhythm problems).
  • Stop the medicine and call your doctor at the first sign of a skin rash, especially with fever and many small pustules (pus-filled bumps), which can signal AGEP, a serious skin reaction.
  • Seek care for signs of an allergic reaction.
  • Tell your doctor about hallucinations, tremor or convulsions.

Hydroxyzine warnings and precautions

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  • Hydroxyzine can cause drowsiness. Avoid driving or operating dangerous machinery until you know how it affects you.
  • It can boost the effects of narcotics, other pain relievers, barbiturates, other CNS depressants and alcohol.
  • It can rarely cause QT prolongation and Torsade de Pointes, dangerous heart rhythm problems.
  • It can rarely cause AGEP, a serious skin reaction. Stop it at the first sign of a rash or hypersensitivity, and do not restart if AGEP is suspected.
  • Its long-term effectiveness for anxiety (more than 4 months) has not been studied, so your prescriber should reassess it periodically.

Hydroxyzine interactions

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Hydroxyzine can add to the effects of other sedating drugs and heart-rhythm-affecting drugs.

  • Narcotics, non-narcotic analgesics, barbiturates and other CNS depressants: stronger sedation, so their doses should be reduced.
  • Alcohol: effects may be increased.
  • QT-prolonging drugs (certain antiarrhythmics, antipsychotics, antidepressants, antibiotics, methadone, ondansetron): added risk of heart rhythm problems.
  • Meperidine and barbiturates around anesthesia: hydroxyzine may potentiate them, so their use is adjusted individually.
  • Cetirizine or levocetirizine: avoid if you had AGEP or hypersensitivity to hydroxyzine, due to cross-sensitivity.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Hydroxyzine

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  • Do not take it if you are allergic to hydroxyzine, cetirizine or levocetirizine.
  • Do not take it with a prolonged QT interval.
  • It is contraindicated in early pregnancy.
  • It should not be given to nursing mothers.
  • Use caution with heart disease, recent heart attack, uncompensated heart failure, slow heart rhythms, electrolyte imbalances, or personal or family history of long QT syndrome.
  • Older adults may become confused or over-sedated and generally start on low doses with close monitoring.

Hydroxyzine overdose

▾

The most common sign of overdose is heavy sedation. Convulsions, stupor, nausea and vomiting have also been reported, and overdose may cause QT prolongation and Torsade de Pointes. There is no specific antidote, so treatment is supportive care with close monitoring, including ECG monitoring. Get emergency help right away.

What Hydroxyzine does in the body

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Hydroxyzine produces a calming effect without impairing mental alertness. It has antihistamine, antiemetic and antispasmodic effects, and experimentally shows skeletal muscle relaxation. At therapeutic doses it does not increase stomach acid and usually has mild antisecretory benefit.

How to store Hydroxyzine

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Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

183

Supplements & herbs that interact with Hydroxyzine

183 supplements and herbal products have documented interactions with Hydroxyzine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 135
  • Minor · 43
Every supplement checked against Hydroxyzine — ranked by severity The full interaction hub: 5 major · 135 moderate · 43 minor · every one linked to its full report. Check Hydroxyzine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Hydroxyzine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Hydroxyzine — the kind of thing our pharmacy team would talk through with you at the counter.

What is hydroxyzine used for?

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Taken by mouth, it's used for anxiety and tension, itching from allergic skin conditions like hives and eczema, and sedation around anesthesia. The injection has additional uses in hospital settings, such as alcohol withdrawal and nausea and vomiting.

Will it make me sleepy?

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It can. Drowsiness is the most common effect, though it often fades in a few days or with a lower dose. Don't drive or use dangerous machinery until you know how it affects you.

Can I drink alcohol or take other sedating medicines with it?

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It's best not to. Hydroxyzine can strengthen alcohol, narcotics, barbiturates and other sedating drugs. Tell your prescriber about everything you take, since doses of some may need to be lowered.

What side effects should I call about?

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Dry mouth and headache are usually mild. Call your doctor right away for a fast or irregular heartbeat, fainting, or a rash, especially with fever or small pustules. Also report hallucinations, tremor or convulsions.

Is it safe in pregnancy or while breastfeeding?

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Hydroxyzine should not be used in early pregnancy. It should also not be given to nursing mothers, because it's not known whether it passes into breast milk. Talk with your prescriber if you're pregnant or planning to be.

Can I take it long term?

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Its effectiveness for anxiety beyond 4 months hasn't been formally studied. Your prescriber should check periodically whether it's still helping you.

Is Hydroxyzine available over the counter?

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No. Hydroxyzine is a prescription medicine: every Hydroxyzine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Hydroxyzine first available?

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The earliest FDA record we hold for Hydroxyzine is from 1956: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Hydroxyzine was first used.

Who makes Hydroxyzine?

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54 companies currently list Hydroxyzine products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, NuCare Pharmaceuticals,Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Hydroxyzine on HelloPharmacist

Detailed data & references for Hydroxyzine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Hydroxyzine forms and strengths (how it comes)

Hydroxyzine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Hydroxyzine HCL tablets are used for anxiety and tension associated with psychoneurosis.
  • Hydroxyzine HCL tablets are used for itching from allergic conditions such as chronic urticaria and atopic and contact dermatoses.
  • HydrOXYzine Hydrochloride tablets are used as a sedative before and after general anesthesia.
Important instructions
  • Hydroxyzine HCL tablets are taken by mouth, usually several times daily, with children's doses based on age or weight.
  • HydrOXYzine Hydrochloride tablets: if treatment began by injection, later doses may be oral.
Available strengths 3 strengths
332 FDA-listed product records ⓘ

Capsule

By mouth
Brands Hydroxyzine Pamoate
How this form is used
What it may be used for
  • Hydroxyzine Pamoate is used for symptomatic relief of anxiety and tension associated with psychoneurosis.
  • Hydroxyzine Pamoate is used for itching from allergic conditions such as chronic urticaria and atopic and contact dermatoses.
  • Hydroxyzine Pamoate is used as a sedative before and after general anesthesia.
Important instructions
  • Hydroxyzine Pamoate is taken by mouth, usually several times daily, with doses for children based on age or weight.
  • Hydroxyzine Pamoate: if treatment began by injection, later doses may be given orally.
Available strengths 3 strengths
156 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Hydroxyzine Hydrochloride oral solution is used for anxiety and tension associated with psychoneurosis.
  • Hydroxyzine Hydrochloride oral solution is used for itching from allergic conditions such as chronic urticaria and atopic and contact dermatoses.
  • Hydroxyzine Hydrochloride oral solution is used as a sedative around general anesthesia.
Important instructions
  • Hydroxyzine Hydrochloride oral solution is taken by mouth, usually several times daily, with children's doses based on age or weight.
  • Hydroxyzine Hydrochloride oral solution: if treatment began by injection, later doses may be oral.
Available strengths 2 strengths
19 FDA-listed product records ⓘ

Injection

Into a muscle
How this form is used
What it may be used for
  • Hydroxyzine Hydrochloride injection is used for acutely disturbed or hysterical patients.
  • Hydroxyzine Hydrochloride injection is used for alcoholics with anxiety withdrawal symptoms or delirium tremens.
  • Hydroxyzine Hydrochloride injection is used as an add-on before and after surgery and childbirth, and for nausea and vomiting (not of pregnancy).
Important instructions
  • Hydroxyzine Hydrochloride injection is given into a muscle and may be given without further dilution.
  • Hydroxyzine Hydrochloride injection: patients should be maintained on oral therapy whenever practical.
Available strengths 2 strengths
16 FDA-listed product records ⓘ

Hydroxyzine on the U.S. market: products, makers and brands

How Hydroxyzine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

54 companies list 278 Hydroxyzine product records with the FDA, mostly as tablet, capsule, oral solution; the earliest marketing or approval year on record is 1956. Brand names on the directory include Vistaril, Atarax, Hypam and 2 more; the rest are generics.

4
Dose forms ⓘ
54
Labelers (makers, repackagers, distributors)
4
Brand names
278
FDA-listed product records ⓘ
1956
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (33) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack14%
A-S Medication Solutions9%
NuCare Pharmaceuticals,Inc.5%
Remedyrepack Inc.5%
PD-Rx Pharmaceuticals, Inc.5%
Proficient Rx LP5%
Other makers56%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Hydroxyzine is used (Medicaid data)

A general measure of how commonly Hydroxyzine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hydroxyzine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

9,012,994
Medicaid prescriptions filled (Q1–Q4 2025)
$106.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hydroxyzine prescribed? Of the 1,601 medications we measure, Hydroxyzine ranks #12 by Medicaid prescriptions — more than 99% of them.

Where Hydroxyzine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Hydroxyzine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 25 mg oral tablet is the most-dispensed Hydroxyzine product — about 39% of these Medicaid prescriptions.

hydroxyzine hydrochloride 25 MG Oral Tablet Most dispensed

3,535,924 Medicaid prescriptions (Q1–Q4 2025) 39% of Hydroxyzine prescriptions shown $36.4M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 28 of 327 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995258

hydroxyzine hydrochloride 50 MG Oral Tablet

1,446,472 Medicaid prescriptions (Q1–Q4 2025) 16% of Hydroxyzine prescriptions shown $16.9M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 20 of 166 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995281

hydroxyzine pamoate 25 MG Oral Capsule

1,442,772 Medicaid prescriptions (Q1–Q4 2025) 16% of Hydroxyzine prescriptions shown $15.5M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 13 of 226 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995253

hydroxyzine hydrochloride 10 MG Oral Tablet

1,115,296 Medicaid prescriptions (Q1–Q4 2025) 12% of Hydroxyzine prescriptions shown $10.4M gross reimbursement (before rebates) ≈ $9.30 per prescription (gross)

Summed across the 18 of 161 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995218

hydroxyzine pamoate 50 MG Oral Capsule

1,054,252 Medicaid prescriptions (Q1–Q4 2025) 12% of Hydroxyzine prescriptions shown $12.1M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 12 of 112 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995278

hydroxyzine hydrochloride 2 MG/ML Oral Solution

311,619 Medicaid prescriptions (Q1–Q4 2025) 3% of Hydroxyzine prescriptions shown $11.7M gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 6 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995241

hydroxyzine pamoate 100 MG Oral Capsule

104,530 Medicaid prescriptions (Q1–Q4 2025) 1% of Hydroxyzine prescriptions shown $3.5M gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995232

1 ML hydroxyzine hydrochloride 50 MG/ML Injection

1,651 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydroxyzine prescriptions shown $119,142 gross reimbursement (before rebates) ≈ $72 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1794554

1 ML hydroxyzine hydrochloride 25 MG/ML Injection

453 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydroxyzine prescriptions shown $19,120 gross reimbursement (before rebates) ≈ $42 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 995270

2 ML hydroxyzine hydrochloride 50 MG/ML Injection

25 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydroxyzine prescriptions shown $197 gross reimbursement (before rebates) ≈ $7.87 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1794552

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hydroxyzine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 101 of 1,037 listed Hydroxyzine NDCs with Medicaid activity.

Compare Hydroxyzine products

A representative set of FDA-listed product records for Hydroxyzine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 109 of 278 products — FDA National Drug Code Directory. See every product, package size and price: browse all 278 Hydroxyzine NDCs →

Hydroxyzine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Hydroxyzine recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Jun 2, 2026 · ANI Pharmaceuticals, Inc.
Presence of foreign substance
  • hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 Lots: Lot S25133A FDA record D-0619-2026 →
Class II Apr 13, 2022 · Terminated · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
  • HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-1046-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Hydroxyzine RxCUI 5553 6 dose forms · 13 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 370661 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 50 MG/ML RxCUI 995285
  2. Dose form (SCDF) Oral Solution RxCUI 372441 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 2 MG/ML RxCUI 995241
  3. Dose form (SCDF) Oral Suspension RxCUI 370663 No current FDA listing
    Clinical drug / strength (SCD) pamoate 5 MG/ML RxCUI 995274

Look up RxCUI 5553 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Hydroxyzine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 25 mg $0.033 per tablet NDC details & price history
Tablet, Film Coated · Oral 50 mg $0.056 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $0.029 per tablet NDC details & price history
Capsule · Oral 25 mg $0.064 per capsule NDC details & price history
Capsule · Oral 50 mg $0.082 per capsule NDC details & price history
Capsule · Oral 100 mg $0.426 per capsule NDC details & price history
Solution · Oral 10 mg/5 mL $0.113 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Hydroxyzine brand names

Hydroxyzine is sold under 5 brand names in the FDA directory — Vistaril, Atarax, Hypam, Orgatrax and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Vistaril Atarax Hypam Orgatrax Hydroxyzine Pamoate

Who makes Hydroxyzine: manufacturers and labelers

54 companies list Hydroxyzine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, NuCare Pharmaceuticals,Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 40 A-S Medication Solutions 25 NuCare Pharmaceuticals,Inc. 15 Remedyrepack Inc. 15 PD-Rx Pharmaceuticals, Inc. 14 Proficient Rx LP 14 Chartwell RX, LLC 11 Northwind Health Company, LLC 9 Aphena Pharma Solutions - Tennessee, LLC 8 Coupler LLC 7 Preferred Pharmaceuticals Inc. 7 Asclemed USA, Inc. 6 Direct_Rx 6 Teva Pharmaceuticals USA, Inc. 6 American Health Packaging 5 Golden State Medical Supply, Inc. 5 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 5 NCS HealthCare of KY, LLC dba Vangard Labs 5 Unit Dose Solutions, Inc. 5 Major Pharmaceuticals 4 Advanced Rx of Tennessee, LLC 3 American Regent, Inc. 3 Amneal Pharmaceuticals LLC 3 Aurobindo Pharma Limited 3

…and 30 more on the FDA NDC directory.

Hydroxyzine drug class (RxNorm)

Hydroxyzine belongs to the Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Diphenylmethane derivatives
How it works Histamine Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Hydroxyzine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 25, 2024
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hydroxyzine.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hydroxyzine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
225
Finished products in the current FDA directory
278
Companies listing them (makers, repackagers, distributors)
54
FDA labeler codes behind them ⓘ
61
Linked representative label ⓘ
Amneal Pharmaceuticals LLC
Linked label effective
Oct 25, 2024
Composite sections available
11
Linked SPL Set ID
89901966-724b-4773-98b8-ea663ceabd53
Linked SPL Document ID
6c929cf4-2a16-4956-b410-8e44db920604
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amneal Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →