Cetirizine Hydrochloride (Hives Relief) 5 mg Tablet, 30-count
by Aurohealth LLC · 1 BOTTLE in 1 CARTON (58602-446-09) / 30 TABLET in 1 BOTTLE
NDC 58602-0446-09
🏷️ FDA NDC (as labeled)
58602-446-09
billing pads the product segment with a zero
This package
Contains30-count
Pack sizes5 compare ↓
Also comes in:
45 tablets 58602-0446-17
75 tablets 58602-0446-47
100 tablets 58602-0446-21
1000 tablets 58602-0446-41
OTC
Generic
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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)
58602-446-09
Product NDC
58602-446
11-digit billing NDC
58602044609
UNII
64O047KTOA
Application #
ANDA090760
SPL Set ID
2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a
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
2015-08-05
Route
ORAL
Dosage form
TABLET
Substance
CETIRIZINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 58602-446-09 — 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 → 58602-0446-09. 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
LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA090760 (ANDA)
Labeler code58602
First marketedAug 2015
Product typeHuman Otc Drug
Portfolio175 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:
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.
💬 Questions about Cetirizine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeRectangle
ImprintX;2;0
Size9 mm
ScoringScored — splits in 2
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 system | Per each | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride 5 mg 00378-3635-01 | Mylan | 100 tablets | $0.048 | — | Availability likely | — |
| Cetirizine Hydrochloride 5 mg 16571-0401-10 | Rising | 100 tablets | $0.048 | — | Availability likely | — |
| Cetirizine Hydrochloride 5 mg 49483-0682-01 | TIME | 100 tablets | $0.048 | — | Availability likely | — |
| Cetirizine Hydrochloride Tablets, 5 mg 25000-0219-03 | MARKSANS | 30 tablets | — | — | FDA listed | — |
| Zyrtec Allergy 5 mg 50580-0754-15 | Kenvue | 1 tablet | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 5 mg 58602-0444-09 | Aurohealth | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Hives Relief) 5 mgthis 58602-0446-09 | Aurohealth | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg 63629-4914-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg 65162-0045-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride Hives Relief 5 mg 65162-0145-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg 71205-0093-15 | Proficient | 15 tablets | — | — | FDA listed | — |
| Cetirizine HCl 5 mg 72657-0128-03 | GLENMARK | 300 tablets | — | — | FDA listed | — |
| Cetirizine HCl 72657-0130-05 | GLENMARK | 90 tablets | — | — | 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
🏛️
2015
On the market since
Aug 2015
📍
2026
Currently FDA-listed
11 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.
🔬 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 (Hives Relief) (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 21%
Female · 79%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58602-0446-09 You're viewing this | 1 BOTTLE in 1 CARTON (58602-446-09) / 30 TABLET in 1 BOTTLE | 2015-08-05 | Active |
| 58602-0446-17 | 1 BOTTLE in 1 CARTON (58602-446-17) / 45 TABLET in 1 BOTTLE | 2015-08-05 | Active |
| 58602-0446-21 | 10 BLISTER PACK in 1 CARTON (58602-446-21) / 10 TABLET in 1 BLISTER PACK | 2015-08-05 | Active |
| 58602-0446-41 | 1000 TABLET in 1 BOTTLE (58602-446-41) | 2015-08-05 | Active |
| 58602-0446-47 | 75 TABLET in 1 PACKAGE, COMBINATION (58602-446-47) | 2015-08-05 | Active |
Pack size FAQ
What quantity is in NDC 58602-0446-09?
NDC 58602-0446-09 is a 30-count package — 1 bottle in 1 carton / 30 tablet in 1 bottle.
What is the difference between NDC 58602-0446-09 and NDC 58602-0446-17?
Both are Cetirizine Hydrochloride (Hives Relief) 5 mg Tablet — the drug itself is identical. NDC 58602-0446-09 is the 30-count package, while NDC 58602-0446-17 is the 45 tablets package.
What NDC number is used to bill for this package of Cetirizine Hydrochloride (Hives Relief) 5 mg Tablet?
Bill NDC 58602-0446-09 — the 11-digit billing format is 58602044609. 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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 58602-446-09, 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: 58602-0446-09, written without dashes as 58602044609. 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 58602-0446-09, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0446) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 Aurohealth 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 4 other package presentations of this same product, including 45 tablets (58602-0446-17), 75 tablets (58602-0446-47), 100 tablets (58602-0446-21). 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?
Aurohealth 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 ▾
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 ▾
Directions For 5 mg: adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
⚠️ Warnings ▾
Warnings 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.
📦 Storage and Handling ▾
Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
🧪 Active Ingredient ▾
Active ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride USP 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
🎯 Purpose ▾
Purpose Antihistamine
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.