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Cetirizine Hydrochloride 5 mg/5mL Solution, 118 mL — NDC 65162-0684-86 package photo

Cetirizine Hydrochloride 5 mg/5mL Solution, 118 mL

by Amneal Pharmaceuticals LLC · 118 mL in 1 BOTTLE (65162-684-86)
NDC 65162-0684-86
🏷️ FDA NDC (as labeled) 65162-684-86 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Also comes in: 473 ml 65162-0684-90
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Cetirizine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0348-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65162-684-86
Product NDC 65162-684
11-digit billing NDC 65162068486
RxCUI 1014673
UNII 64O047KTOA
UPC 0365168684265, 0365162684902
Application # ANDA090766
SPL Set ID 365cbabe-535b-4c34-852b-6cd63782e3e5
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-10-07
Route ORAL
Dosage form SOLUTION
Substance CETIRIZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 65162-684-86 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65162-0684-86. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives, Other antiallergics
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA090766 (ANDA)
Labeler code65162
First marketedOct 2009
Product typeHuman Prescription Drug
Portfolio472 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Cetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Cetirizine is also used to treat urticaria (hives; itchy raised red bumps on skin). Cetirizine 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. Cetirizine is also available in combination with pseudoephedrine. This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Cetirizine is an antihistamine that helps with allergies and hives. Most oral products — tablets, capsules, solutions — treat classic allergy symptoms like runny nose, sneezing, it...
  • It can, yes — drowsiness is the most commonly reported side effect. Cetirizine is considered less sedating than older antihistamines because it doesn't penetrate the brain as readi...
  • You can take oral cetirizine with or without food — it doesn't matter much. Food doesn't reduce the total amount absorbed, though it can delay the peak effect by an hour or two. So...
  • Can I take cetirizine with food, or does it need to be on an empty stomach?
📖 Read our full Cetirizine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow
FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • 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.
  • 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.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 473 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 1 mg/mL 00121-0874-04 PAI 120 ml $0.023 AA Availability likely —
Cetirizine Hydrochloride 1 mg/mL 16571-0134-12 Rising 120 ml $0.023 AA Availability likely —
Cetirizine Hydrochloride 1 mg/mL 45802-0626-26 Padagis 1 bottle $0.023 AA Availability likely —
Cetirizine Hydrochloride 1 mg/mL 51672-4070-08 Sun 1 bottle $0.023 AA Availability likely —
Cetirizine Hydrochloride Oral Solution 5 mg/5mL 62135-0057-41 Chartwell 120 ml $0.023 AA Availability likely —
Cetirizine Hydrochloride 1 mg/mL 69452-0426-55 Bionpharma 120 ml $0.023 AA Availability likely —
Cetirizine hydrochloride 1 mg/mL 72888-0480-01 Advagen 120 ml $0.023 AA Availability likely —
Cetirizine Hydrochloride Oral Solution 1 mg/mL 83745-0185-04 APOZEAL 120 ml $0.023 AA Availability likely —
Good Neighbor Pharmacy Childrens All Day Allergy 5 mg/5mL 46122-0203-26 Amerisource 1 bottle $0.035 — Availability likely —
Cetirizine Hydrochloride 1 mg/mL 57237-0357-12 Rising 120 ml $0.035 — Availability likely —
Cetirizine Hydrochloride 1 mg/mL 57237-0358-12 Rising 120 ml $0.035 — Availability likely —
foster and thrive childrens allergy relief 5 mg/5mL 70677-1042-01 Strategic 1 bottle $0.035 — Availability likely —
Cetirizine Hydrochloride 1 mg/mL 70677-1236-01 STRATEGIC 1 bottle $0.035 — Availability likely —
Childrens Allergy Relief 1 mg/mL 70677-0149-01 Strategic 1 bottle $0.037 — FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0189-26 L. 1 bottle $0.037 — Availability likely —
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0503-26 L. 1 bottle $0.037 — Availability likely —
childrens cetirizine hydrochloride 5 mg/5mL 00904-6765-20 Major 1 bottle $0.037 — Availability likely —
cetirizine hydrochloride 5 mg/5mL 45802-0974-26 Padagis 1 bottle $0.037 — Availability likely —
All Day Allergy 5 mg/5mL 46122-0101-26 Amerisource 1 bottle $0.037 — Availability likely —
Childrens Allergy Relief 1 mg/mL 69230-0316-11 Camber 1 bottle $0.037 — Availability likely —
Leader Childrens All Day Allergy 5 mg/5mL 70000-0214-01 Cardinal 1 bottle $0.037 — Availability likely —
Leader Childrens all day allergy 5 mg/5mL 70000-0215-01 Cardinal 1 bottle $0.037 — Availability likely —
Cetirizine Hydrochloride 1 mg/mL 70752-0104-06 QUAGEN 1 bottle $0.037 — Availability likely —
Cetrizine Hydrochloride 1 mg/mL 83745-0188-04 APOZEAL 1 bottle $0.037 — Availability likely —
Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL 68094-0004-62 Precision 10 cups $0.447 — Availability likely —
Wal-Zyr All Day Allergy 5 mg/5mL 00363-2106-01 WALGREEN 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 00363-3311-26 Walgreen 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 00363-3393-26 Walgreen 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 11822-0475-00 Rite 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 11822-1189-00 Rite 1 bottle — — FDA listed —
Rite Aid childrens allergy relief 1 mg/mL 11822-2106-08 Rite 1 bottle — — FDA listed —
childrens cetirizine hydrochloride 5 mg/5mL 17856-6765-01 ATLANTIC 72 cups — — FDA listed —
Signature Care Childrens Allergy Relief 5 mg/5mL 21130-0189-34 Safeway 1 bottle — — Discontinued —
childrens allergy relief 5 mg/5mL 21130-0465-34 Safeway 1 bottle — — FDA listed —
Signature Care Childrens Allergy Relief 5 mg/5mL 21130-0475-26 Safeway 1 bottle — — Discontinued —
childrens allergy relief 5 mg/5mL 21130-0653-26 Safeway 1 bottle — — FDA listed —
Cetirizine hydrochloride 5 mg/5mL 23155-0929-51 Heritage 120 ml — AA FDA listed —
childrens all day allergy 5 mg/5mL 30142-0189-26 Kroger 1 bottle — — FDA listed —
Childrens All Day Allergy 5 mg/5mL 30142-0475-26 Kroger 1 bottle — — FDA listed —
childrens dye free allergy relief 5 mg/5mL 30142-0643-26 Kroger 1 bottle — — FDA listed —
childrens dye free allergy relief 5 mg/5mL 30142-0689-26 Kroger 1 bottle — — FDA listed —
Topcare Childrens All Day Allergy 5 mg/5mL 36800-0189-26 Topco 1 bottle — — FDA listed —
TopCare Childrens All Day Allergy 5 mg/5mL 36800-0475-00 Topco 1 bottle — — FDA listed —
HEB Allergy Relief 5 mg/5mL 37808-0102-08 H 1 bottle — — FDA listed —
Allergy Relief 1 mg/mL 37808-0106-08 H 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 37808-0671-26 H 1 bottle — — Discontinued —
Equaline childrens all day allergy 5 mg/5mL 41163-0475-26 United 1 bottle — — FDA listed —
Childrens 24 Hour Allergy 5 mg/5mL 41250-0189-26 Meijer 1 bottle — — FDA listed —
Childrens 24 Hour Allergy 5 mg/5mL 41250-0475-26 Meijer 1 bottle — — FDA listed —
careone childrens allergy relief 5 mg/5mL 41520-0301-26 American 1 bottle — — FDA listed —
careone childrens allergy relief 5 mg/5mL 41520-0902-26 American 1 bottle — — FDA listed —
Childrens All Day Allergy 5 mg/5mL 42507-0203-26 HyVee 1 bottle — — FDA listed —
childrens all day allergy 5 mg/5mL 42507-0475-26 HyVee 1 bottle — — FDA listed —
Childrens Allergy Relief 5 mg/5mL 49035-0106-08 Wal-Mart 1 bottle — — FDA listed —
Equate Childrens Allergy Relief 5 mg/5mL 49035-0276-01 Wal-Mart 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 50090-1103-00 A-S 1 bottle — — FDA listed —
Childrens Allergy Relief 1 mg/mL 50090-4741-00 A-S 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 50090-5220-00 A-S 1 bottle — AA FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 50090-7068-00 A-S 1 bottle — — FDA listed —
Zyrtec Hives 1 mg/mL 50580-0128-04 Kenvue 1 bottle — — FDA listed —
Childrens Zyrtec Allergy 5 mg/5mL 50580-0721-05 Kenvue 1 bottle — — FDA listed —
Childrens Zyrtec 5 mg/5mL 50580-0730-01 Kenvue 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 51672-2102-01 Sun 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 51672-2106-01 Sun 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride 1 mg/mL 51672-2147-01 Sun 1 bottle — — FDA listed —
Childrens Allergy Relief 1 mg/mL 55315-0354-31 Fred's, 1 bottle — — FDA listed —
DG Health Childrens All Day Allergy 5 mg/5mL 55910-0714-26 Dolgencorp, 1 bottle — — FDA listed —
childrens allergy 5 mg/5mL 56062-0102-08 Publix 1 bottle — — FDA listed —
Childrens Allergy 1 mg/mL 56062-0106-08 Publix 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Allergy 1 mg/mL 58602-0028-20 Aurohealth 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL 58602-0030-20 Aurohealth 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL 58602-0036-15 Aurohealth 1 bottle — — FDA listed —
Childrens Allergy Relief 1 mg/mL 58602-0422-12 Aurohealth 1 bottle — — FDA listed —
Childrens Allergy Relief 5 mg/5mL 59779-0509-26 CVS 1 bottle — — FDA listed —
allergy relief childrens 5 mg/5mL 59779-0837-26 CVS 1 bottle — — FDA listed —
Allergy Relief Childrens 5 mg/5mL 59779-0884-26 CVS 1 bottle — — Discontinued —
Cetirizine Hydrochloride 1 mg/mL 61037-0479-02 BAJAJ 120 ml — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 61037-0480-22 BAJAJ 120 ml — — FDA listed —
Childrens Allergy Relief 1 mg/mL 63868-0865-04 C.D.M.A., 1 bottle — — FDA listed —
Kirkland Signature Childrens Aller Tec 5 mg/5mL 63981-0475-43 Costco 2 bottles — — FDA listed —
Welby Childrens Allergy Relief 5 mg/5mL 64024-0475-26 Aldi 1 bottle — — FDA listed —
Cetirizine Hydrochloride 5 mg/5mL 65162-0003-86 Amneal 1 bottle — — FDA listed —
Cetirizine Hydrochloride 5 mg/5mL 65162-0005-86 Amneal 1 bottle — — FDA listed —
Cetirizine Hydrochloride 5 mg/5mLthis 65162-0684-86 Amneal 118 ml — AA FDA listed —
Childrens Cetirizine Hydrochloride 5 mg/5mL 68016-0023-43 Chain 1 bottle — — FDA listed —
Childrens Cetirzine 5 mg/5mL 68016-0106-08 Pharmacy 1 bottle — — FDA listed —
Premier Value Childrens Cetirizine 5 mg/5mL 68016-0165-00 Pharmacy 1 bottle — — FDA listed —
SIMPLY RIGHT childrens cetirizine 5 mg/5mL 68196-0102-01 Sam's 2 bottles — — Discontinued —
Members Mark Childrens Cetirizine 5 mg/5mL 68196-0475-43 Sam's 2 bottles — — FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 68788-4093-01 Preferred 1 bottle — — FDA listed —
childrens cetirizine hydrochloride 5 mg/5mL 68788-8188-01 Preferred 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 68788-8282-01 Preferred 1 bottle — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 68788-8523-01 Preferred 1 bottle — AA FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 68788-8803-01 Preferred 1 bottle — — FDA listed —
Cetirizine Hydrochloride Oral Solution 1 mg/mL 68788-8890-01 Preferred 120 ml — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 69206-0990-01 Aventura 120 ml — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 70752-0103-06 QUAGEN 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 71205-0435-04 Proficient 1 bottle — AA FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 71205-0705-72 Proficient 1 bottle — — FDA listed —
childrens cetirizine hydrochloride 5 mg/5mL 71205-0722-04 Proficient 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 72162-2073-02 Bryant 1 bottle — — FDA listed —
cetirizine hydrochloride 5 mg/5mL 72162-2339-02 Bryant 1 bottle — — FDA listed —
Basic Care Childrens All Day Allergy 5 mg/5mL 72288-0330-34 Amazon.com 1 bottle — — FDA listed —
basic care childrens all day allergy 5 mg/5mL 72288-0475-34 Amazon.com 1 bottle — — FDA listed —
up and up childrens allergy 5 mg/5mL 82442-0475-26 Target 1 bottle — — FDA listed —
up and up childrens allergy 5 mg/5mL 82442-0617-26 Target 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 83939-0009-01 VERITYRX, 5 ml — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65162-0684-86 You're viewing this 118 mL in 1 BOTTLE (65162-684-86) 2009-10-07 Active
65162-0684-90 473 mL in 1 BOTTLE (65162-684-90) 2009-10-07 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65162-0684-86?
NDC 65162-0684-86 contains 118 mL — 118 ml in 1 bottle.
What is the difference between NDC 65162-0684-86 and NDC 65162-0684-90?
Both are Cetirizine Hydrochloride 5 mg/5mL Solution — the drug itself is identical. NDC 65162-0684-86 is the 118 mL package, while NDC 65162-0684-90 is the 473 ml package.
What NDC number is used to bill for this package of Cetirizine Hydrochloride 5 mg/5mL Solution?
Bill NDC 65162-0684-86 — the 11-digit billing format is 65162068486. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65162-684-86, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65162-0684-86, written without dashes as 65162068486. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65162-0684-86, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0684) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (86) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 473 ml (65162-0684-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 94 words ▾

INDICATIONS AND USAGE Perennial Allergic Rhinitis: Cetirizine hydrochloride 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. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age.

It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

⏱️ Dosage and Administration 150 words ▾

DOSAGE AND ADMINISTRATION Cetirizine hydrochloride oral solution can be taken without regard to food consumption. Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of cetirizine hydrochloride oral solution in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful (5 mg) once daily, or as ½ teaspoonful (2.5 mg) given every 12 hours.

Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria: The recommended dose of cetirizine hydrochloride oral solution in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Pediatric studies were conducted with cetirizine hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks.

Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with cetirizine (0.25 mg/kg bid). The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with cetirizine hydrochloride were mild or moderate.

In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of cetirizine hydrochloride was uncommon (0.4% on cetirizine hydrochloride vs. 1.0% on placebo). Table 1 list adverse experiences which were reported for cetirizine hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with cetirizine hydrochloride than placebo.

Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years. In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences were similar in the cetirizine and placebo treatment groups in each study.

Somnolence occurred with essentially the same frequency in patients who received cetirizine hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received cetirizine exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received cetirizine compared to patients who received placebo (9.0% v.

5.3%). In those patients who received 5 mg or more per day of cetirizine as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v.

1.8%) occurred more frequently. Table 1. Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Cetirizine Hydrochloride Group, and More Frequently Than in the Placebo Group Adverse Experiences Placebo (N=309) Cetirizine Hydrochloride 5 mg (N=161) 10 mg (N=215) Headache 12.3% 11.0% 14.0% Pharyngitis 2.9% 6.2% 2.8% Abdominal pain 1.9% 4.4% 5.6% Coughing 3.9% 4.4% 2.8% Somnolence 1.3% 1.9% 4.2% Diarrhea 1.3% 3.1% 1.9% Epistaxis 2.9% 3.7% 1.9% Bronchospasm 1.9% 3.1% 1.9% Nausea 1.9% 1.9% 2.8% Vomiting 1.0% 2.5% 2.3% The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received cetirizine hydrochloride in U.S. trials, including an open adult study of six months duration.

A causal relationship of these infrequent events with cetirizine hydrochloride administration has not been established. Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention. Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination…

🆘 Overdosage 215 words ▾

OVERDOSAGE Overdosage has been reported with cetirizine hydrochloride. In one adult patient who took 150 mg of cetirizine hydrochloride, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of cetirizine hydrochloride (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness.

Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine hydrochloride. Cetirizine hydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

The acute minimal lethal oral doses were 237 mg/kg in mice (approximately 95 times the maximum recommended daily oral dose in adults on a mg/m 2 basis, or approximately 40 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) and 562 mg/kg in rats (approximately 460 times the maximum recommended daily oral dose in adults on a mg/m 2 basis, or approximately 190 times the maximum recommended daily oral dose in infants on a mg/m 2 basis). In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Actions: Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity.

In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H 1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain.

Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H 1 receptors. Pharmacokinetics Absorption: Cetirizine was rapidly absorbed with a time to maximum concentration (T max ) of approximately 1 hour following administration of oral solution in adults. Comparable bioavailability was found between the tablet and oral solution dosage forms.

When healthy volunteers were administered multiple doses of cetirizine (10 mg tablets once daily for 10 days), a mean peak plasma concentration (C max ) of 311 ng/mL was observed. No accumulation was observed. Cetirizine pharmacokinetics were linear for oral doses ranging from 5 mg to 60 mg.

Food had no effect on the extent of cetirizine hydrochloride exposure (AUC) but T max was delayed by 1.7 hours and C max was decreased by 23% in the presence of food. Distribution: The mean plasma protein binding of cetirizine is 93%, independent of concentration in the range of 25 ng/mL to 1000 ng/mL, which includes the therapeutic plasma levels observed. Metabolism: A mass balance study in 6 healthy male volunteers indicated that 70% of the administered radioactivity was recovered in the urine and 10% in the feces.

Approximately 50% of the radioactivity was identified in the urine as unchanged drug. Most of the rapid increase in peak plasma radioactivity was associated with parent drug, suggesting a low degree of first-pass metabolism. Cetirizine is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity.

The enzyme or enzymes responsible for this metabolism have not been identified. Elimination: The mean elimination half-life in 146 healthy volunteers across multiple pharmacokinetic studies was 8.3 hours and the apparent total body clearance for cetirizine was approximately 53 mL/min. Interaction Studies Pharmacokinetic interaction studies with cetirizine hydrochloride in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin.

No interactions were observed. In a multiple dose study of theophylline (400 mg once daily for 3 days) and cetirizine (20 mg once daily for 3 days), a 16% decrease in the clearance of cetirizine was observed. The disposition of theophylline was not altered by concomitant cetirizine administration.

Special Populations Pediatric Patients : In pediatric patients aged 2 to 5 years who received 5 mg of cetirizine hydrochloride, the mean C max was 660 ng/mL. Based on cross-study comparisons, the weight-normalized apparent total body clearance was 81% to 111% greater and the elimination half-life was 33% to 41% shorter in this pediatric population than in adults. In pediatric patients aged 6 to 23 months who received a single dose of 0.25 mg/kg cetirizine hydrochloride oral solution (mean dose 2.3 mg), the mean C max was 390 ng/mL.

Based on cross-study comparisons, the weight-normalized, apparent total body clearance was 304% greater and the elimination half-life was 63% shorter in this pediatric population compared to adults. The average AUC( 0-t ) in children 6 months to <2 years of age receiving the maximum dose of cetirizine hydrochloride oral solution (2.5 mg twice a day) is expected to be two-fold highe…

📦 How Supplied / Storage and Handling 104 words ▾

HOW SUPPLIED Cetirizine hydrochloride oral solution, USP is a clear, colorless to pale yellow solution with a grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride, USP. Cetirizine hydrochloride oral solution, USP is available as: 4 fl. oz (118 mL): NDC 65162-684-86 16 fl. oz (473 mL): NDC 65162-684-90 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F); [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

05-2025-03

📋 Description 134 words ▾

DESCRIPTION Cetirizine hydrochloride is an orally active and selective H 1 -receptor antagonist. The chemical name is (±) - [2- [4- [(4-chlorophenyl) phenylmethyl]- 1 - piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C 21 H 25 ClN 2 O 3 •2HCl.

The molecular weight is 461.82 and the chemical structure is shown below: Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a clear, colorless to pale yellow solution containing cetirizine hydrochloride, USP at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5.

The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate, sucrose and water. b91292b2-figure-01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65162-0683-12 · Amneal 65162-0685-86 · Amneal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.