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CETIRIZINE HYDROCHLORIDE 1 mg/mL Solution, 240 mL — NDC 61037-0480-04 package photo

CETIRIZINE HYDROCHLORIDE 1 mg/mL Solution, 240 mL

by BAJAJ MEDICAL, LLC · 240 mL in 1 BOTTLE, PLASTIC (61037-480-04)
NDC 61037-0480-04
🏷️ FDA NDC (as labeled) 61037-480-04 billing pads the product segment with a zero
This package
Contains240 mL Pack sizes10 compare ↓
Also priced by: Part D plans $0.0685/unit — full pricing hub ↓
Also comes in: 5 ml 61037-0480-26 5 ml 61037-0480-32 5 ml 61037-0480-06 5 ml 61037-0480-12 120 ml 61037-0480-22 120 ml 61037-0480-02 240 ml 61037-0480-24 480 ml 61037-0480-23 480 ml 61037-0480-03
OTC Generic On market Non-controlled
🗂️ Data synced Sep 10, 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 Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jun 24, 2026 — Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0732-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0032-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0033-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 61037-480-04
Product NDC 61037-480
11-digit billing NDC 61037048004
RxCUI 1014673
UNII 64O047KTOA
UPC 0361037480327
Application # ANDA091327
SPL Set ID 36b6d0e4-8da5-9df5-e063-6294a90af326
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 2025-05-08
Route ORAL
Dosage form SOLUTION
Substance CETIRIZINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 61037-480-04 — 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 → 61037-0480-04. 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

LabelerBAJAJ MEDICAL, LLC
Application holderBAJAJ MEDICAL LLC
FDA applicationANDA091327 (ANDA)
Labeler code61037
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio6 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

📗 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 →

Supplement & herbal interactions

Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:

BeerModerate WineModerate Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Cetirizine Hydrochloride (5 interactions) — ranked by severity →
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

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.

The official label also statesglacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 · Q2 2026 $0.0685 $16.44 / 240 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/mLthis 61037-0480-04 BAJAJ 240 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/5mL 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cetirizine Hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue18,984
Pain16,031
Rash13,524
Headache12,772
Pruritus12,668
Nausea11,971
Dyspnoea11,250

Age at onset

Neonate197
Infant363
Child2,567
Adolescent1,715
Adult22,738
Elderly9,926

Reporter sex

166,310 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization38,192
Disabling11,004
Death10,839
Life-threatening9,684
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 14,960 7,068
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61037-0480-22 120 mL in 1 BOTTLE, PLASTIC (61037-480-22) 2025-05-08 Active
61037-0480-23 480 mL in 1 BOTTLE, PLASTIC (61037-480-23) 2025-05-08 Active
61037-0480-24 240 mL in 1 BOTTLE, PLASTIC (61037-480-24) 2025-05-08 Active
61037-0480-26 5 mL in 1 CUP, UNIT-DOSE (61037-480-26) 2025-05-08 Active
61037-0480-32 5 mL in 1 BOX, UNIT-DOSE (61037-480-32) 2025-05-08 Active
61037-0480-02 120 mL in 1 BOTTLE, PLASTIC (61037-480-02) 2025-05-08 Active
61037-0480-03 480 mL in 1 BOTTLE, PLASTIC (61037-480-03) 2025-05-08 Active
61037-0480-04 You're viewing this 240 mL in 1 BOTTLE, PLASTIC (61037-480-04) 2025-05-08 Active
61037-0480-06 5 mL in 1 CUP, UNIT-DOSE (61037-480-06) 2025-05-08 Active
61037-0480-12 5 mL in 1 BOX, UNIT-DOSE (61037-480-12) 2025-05-08 Active

Pack size FAQ

What quantity is in NDC 61037-0480-04?
NDC 61037-0480-04 contains 240 mL — 240 ml in 1 bottle, plastic.
What is the difference between NDC 61037-0480-04 and NDC 61037-0480-26?
Both are CETIRIZINE HYDROCHLORIDE 1 mg/mL Solution — the drug itself is identical. NDC 61037-0480-04 is the 240 mL package, while NDC 61037-0480-26 is the 5 ml package.
What NDC number is used to bill for this package of CETIRIZINE HYDROCHLORIDE 1 mg/mL Solution?
Bill NDC 61037-0480-04 — the 11-digit billing format is 61037048004. 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

Over-the-counter (OTC) 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 61037-480-04, 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: 61037-0480-04, written without dashes as 61037048004. 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 61037-0480-04, the first segment (61037) is the labeler code FDA assigned to BAJAJ MEDICAL, LLC; the middle segment (0480) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 BAJAJ MEDICAL, 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 9 other package presentations of this same product, including 5 ml (61037-0480-26), 5 ml (61037-0480-32), 5 ml (61037-0480-06). 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?
BAJAJ MEDICAL, 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

⏱️ Dosage and Administration 82 words ▾

Directions use with a dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings Severe Allergy Warning Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use Do not use ■ to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious.

If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks If pregnant or breast-feeding : if breast-feeding: not recommended if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away toll-free number 1-800-222-1222.

📦 Storage and Handling 19 words ▾

Other information Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

🧪 Active Ingredient 12 words ▾

Active Ingredient (in each 5 mL teaspoonful) Cetirizine hydrochloride, USP 5 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61037-0479-02 · BAJAJ 61037-0484-03 · BAJAJ →
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.