Hydroxyzine Hydrochloride 10 mg/5mL Solution, 473 mL — NDC 0121-1034-16 (Billing 00121-1034-16)
This is a package of 473 mL of Hydroxyzine Hydrochloride 10 mg/5mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Apr 2002 and currently FDA-listed; retail pharmacies pay about $0.1132 per mL (NADAC). It is this product's only package size.
Other active recalls for Hydroxyzine Hydrochloride (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 003725
- GCN: 13932
- GPI-14 (Medi-Span): 57200040101210
- HICL (First Databank): 001608
- AHFS class code: 04:04.00.00
- RxCUI (RxNorm): 995241
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antihistamine class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Hydroxyzine is used to relieve itching caused by allergic skin reactions, to relieve anxiety and tension, and as a sedative before and after general anesthesia for surgery. Hydroxyzine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. It also works by decreasing activity in the brain.
Read the full MedlinePlus article ↗- 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...
- 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.
- 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...
- Can I drink alcohol or take other sedating medicines with it?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.113 | $53.54 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1891 | $89.44 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1500 | $70.95 / 473 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00121-1034-16 You're viewing this Main listing | 473 mL in 1 BOTTLE | 2024-11-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride 10 mg/5mLthis 00121-1034-16 | PAI | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 54838-0502-80 | Lannett | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 62135-0502-47 | Chartwell | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 62135-0750-47 | Chartwell | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 69452-0395-88 | Bionpharma | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 70954-0912-10 | ANI | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 83745-0232-16 | APOZEAL | 473 ml | $0.113 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 17856-0507-01 | ATLANTIC | 72 cups | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg/25mL 62135-0050-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 63187-0494-04 | Proficient | 118 ml | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg/25mL 68999-0050-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 71656-0090-16 | Saptalis | 473 ml | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 81033-0031-44 | Kesin | 40 cups | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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. 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 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. Hydroxyzine is not known to interfere with the action of digitalis in any way, and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies.
The physician should reassess periodically the usefulness of the drug for the individual patient.
⏱️ Dosage and Administration ▾
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, 50–100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and over 6 years, 50–100 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 t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50–100 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.
⛔ 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. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range.
Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.
⚠️ Warnings ▾
WARNINGS Keep out of the reach of children. Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP), fixed drug eruptions, pruritis, rash, and urticaria in postmarketing reports. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose.
Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes.
🆘 Overdosage ▾
OVERDOSAGE The most common manifestation of hydroxyzine overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting has not occurred spontaneously, it should be induced.
Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol.
Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.
There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated.
There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally.
Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal tract and its clinical effects are usually noted within 15 to 30 minutes after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) 10 mg per 5 mL (teaspoonful) is a clear, colorless to slightly yellow solution supplied as: 16 fl oz bottles (473 mL) [NDC 0121-1034-16]
📋 Description ▾
DESCRIPTION Hydroxyzine hydrochloride is designated chemically as ( ±)2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows: Inactive Ingredients for Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) are: alcohol 0.5% (v/v), citric acid anhydrous, purified water, sodium benzoate, sodium citrate, sucrose. It may also contain sodium hydroxide for pH adjustment.
The pH range is between 4.0 and 4.8. This is an image of the structural formula for hydroxyzine hydrochloride.
⚠️ Precautions ▾
PRECAUTIONS THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS, AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine.
The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.
Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).
Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased. Geriatric Use: A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. The extent of renal excretion of hydroxyzine has not been determined.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely. Acute Generalized Exanthematous Pustulosis (AGEP) Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, nonfollicular, sterile pustules, arising within large areas of edematous erythema.
Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0121- 1034 -16 HydrOXYzine Hydrochloride Oral Solution, USP (Syrup) 10 mg/5 mL Alcohol .... 0.5% (v/v) DO NOT USE IF INNER FOIL SEAL IS BROKEN OR MISSING. This container not intended for household use. Rx ONLY NET: 16 fl oz (473 mL) PAI Pharma Hydroxyzine Hydrochloride Oral Solution USP (Syrup), 10 mg/5 mL bottle label