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Prescription medicine · generic available

Hydroxyzine

Also listed by the FDA as: hydroxyzine dihydrochloride · hydroxyzine pamoate · hydroxyzine hydrochloride

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
8Recalls (FDA reports)
56Companies
1981First FDA approval on file

Quick answers

What is Hydroxyzine used for?
The FDA-approved label (HydrOXYzine Hydrochloride, Remedyrepack Inc., September 8, 2026) says: “For 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Hydroxyzine have a boxed warning?
No. None of the 209 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Hydroxyzine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Hydroxyzine been recalled?
FDA enforcement reports list 8 recalls of products of this medicine; the newest started June 2, 2026 (Class III). A recall usually concerns specific lots, not every product.
Who makes Hydroxyzine?
56 companies list prescription products of Hydroxyzine in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and NuCare Pharmaceuticals, Inc..

What Hydroxyzine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

For 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. …

— FDA label: HydrOXYzine Hydrochloride, Remedyrepack Inc., effective September 8, 2026. Read the full label on DailyMed →

The FDA has 209 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 209 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Capsule · Tablet · Solution · Injection, solution · Syrup
RouteOral · Intramuscular
Prescription products280 in the FDA NDC Directory

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Hydroxyzine, by strength and form
Strength and formGeneric or brandPharmacies pay
hydroxyzine dihydrochloride 10 mg
tablet		 Generic $0.0291 per tablet
hydroxyzine dihydrochloride 10 mg
tablet, film coated		 Generic $0.0291 per tablet
hydroxyzine dihydrochloride 10 mg/5 mL
solution		 Generic $0.1116 per mL
hydroxyzine dihydrochloride 10 mg/5 mL
syrup		 Generic $0.1116 per mL
hydroxyzine dihydrochloride 25 mg
tablet		 Generic $0.0324 per tablet
hydroxyzine dihydrochloride 25 mg
tablet, film coated		 Generic $0.0324 per tablet
hydroxyzine dihydrochloride 50 mg
tablet		 Generic $0.0543 per tablet
hydroxyzine dihydrochloride 50 mg
tablet, film coated		 Generic $0.0543 per tablet
hydroxyzine hydrochloride 10 mg
tablet, film coated		 Generic $0.0291 per tablet
hydroxyzine hydrochloride 10 mg/5 mL
solution		 Generic $0.1116 per mL
hydroxyzine hydrochloride 25 mg
tablet		 Generic $0.0324 per tablet
hydroxyzine hydrochloride 25 mg
tablet, film coated		 Generic $0.0324 per tablet
hydroxyzine hydrochloride 50 mg
tablet		 Generic $0.0543 per tablet
hydroxyzine pamoate 100 mg
capsule		 Generic $0.4231 per capsule
hydroxyzine pamoate 25 mg
capsule		 Generic $0.0650 per capsule
hydroxyzine pamoate 50 mg
capsule		 Generic $0.0815 per capsule

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (33)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. June 2, 2026 · Class III · Ongoing · D-0619-2026

    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 — ANI Pharmaceuticals, Inc.

  2. April 13, 2022 · Class II · Terminated · D-1046-2022

    cGMP deviations: Temperature abuse

    HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01 — Mckesson Medical-Surgical Inc. Corporate Office

  3. October 11, 2018 · Class II · Terminated · D-0083-2019

    CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

    HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80. — Lannett Company, Inc.

  4. January 24, 2014 · Class II · Terminated · D-1093-2014

    CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

    Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 — Teva Pharmaceuticals USA

  5. January 24, 2014 · Class II · Terminated · D-1095-2014

    CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

    Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02. — Teva Pharmaceuticals USA

  6. December 11, 2013 · Class II · Terminated · D-1032-2014

    Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

    HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10. — KVK-Tech, Inc.

  7. December 11, 2013 · Class II · Terminated · D-1031-2014

    Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

    HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10. — KVK-Tech, Inc.

  8. December 11, 2013 · Class II · Terminated · D-1030-2014

    Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

    HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. — KVK-Tech, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)995218, 995232, 995241, 995253, 995258, 995270, 995278, 995281, 995285, 1794552 … (+1)
SPL set ID of the quoted label58d99cf6-2319-410b-b8be-de9c304541b6
FDA labels (SPL)209
FDA applications33 ANDA
Active ingredients (FDA)HYDROXYZINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — HydrOXYzine Hydrochloride, Remedyrepack Inc., effective September 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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