Cetirizine Hydrochloride 10 mg Capsule, Liquid Filled, 12,000-count
by Catalent Ontario Limited · 12000 CAPSULE, LIQUID FILLED in 1 CARTON (61474-4307-1)
NDC 61474-4307-01
🏷️ FDA NDC (as labeled)
61474-4307-1
billing pads the package segment with a zero
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 →
⚠️
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)
61474-4307-1
Product NDC
61474-4307
11-digit billing NDC
61474430701
SPL Set ID
d22c5eb1-708b-6cf6-e053-2995a90a4638
DEA schedule
Non-controlled
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-10-22
Dosage form
CAPSULE, LIQUID FILLED
Substance
CETIRIZINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 61474-4307-1 — a 5-4-1 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 package segment → 61474-4307-01. 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.
🏭 Manufacturer & labeler
LabelerCatalent Ontario Limited
Labeler code61474
First marketedOct 2021
Product typeDrug For Further Processing
Portfolio41 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.
🧪 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 mL | 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 |
|---|---|---|---|---|---|---|
| Good Sense All Day Allergy 10 mg 00113-0981-63 | L. | 25 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 11822-4228-01 | RITE | 25 capsules | — | — | FDA listed | — |
| top care all day allergy 10 mg 36800-0180-09 | Topco | 65 capsules | — | — | FDA listed | — |
| 24 hour allergy 10 mg 41250-0618-63 | Meijer | 25 capsules | — | — | FDA listed | — |
| CareOne Allergy Relief 10 mg 41520-0715-63 | American | 25 capsules | — | — | FDA listed | — |
| dg health all day allergy 10 mg 55910-0710-49 | Dolgencorp, | 40 capsules | — | — | FDA listed | — |
| dg health all day allergy 10 mg 55910-0934-49 | Dolgencorp | 40 capsules | — | — | FDA listed | — |
| allergy relief 10 mg 56062-0111-63 | Publix | 25 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 58602-0716-16 | Aurohealth | 65 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Hives Relief) 10 mg 58602-0808-04 | Aurohealth | 12 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 58602-0863-12 | Aurohealth | 40 capsules | — | — | FDA listed | — |
| basic care all day allergy 10 mg 72288-0007-49 | Amazon.com | 40 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 21130-0099-97 | Better | 25 capsules | — | — | FDA listed | — |
| topcare all day allergy 10 mg 36800-0448-09 | Topco | 65 capsules | — | — | FDA listed | — |
| careone allergy relief 10 mg 72476-0623-63 | Retail | 25 capsules | — | — | FDA listed | — |
| 24 hour allergy 10 mg 79481-0981-00 | Meijer, | 25 capsules | — | — | Discontinued | — |
| Cetirizine Hydrochloride 10 mg 61474-4370-01 | Catalent | 12000 capsules | — | — | FDA listed | — |
| basic care all day allergy 10 mg 72288-0980-49 | Amazon.com | 40 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 00363-0068-12 | WALGREEN | 40 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride 10 mgthis 61474-4307-01 | Catalent | 12000 capsules | — | — | FDA listed | — |
| ZYRTEC Allergy 10 mg 50580-0786-12 | Kenvue | 12 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride 10 mg 59651-0028-22 | Aurobindo | 2000 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride 10 mg 59651-0027-22 | Aurobindo | 2000 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride 10 mg 59651-0628-22 | Aurobindo | 2000 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 58602-0806-04 | Aurohealth | 12 capsules | — | — | FDA listed | — |
| Zyrtec Allergy Cetirizine HCl 10 mg 67414-0012-00 | Jones | 90 capsules | — | — | FDA listed | — |
| cetirizine hydrochloride 10 mg 59556-0894-12 | Strides | 40 capsules | — | — | FDA listed | — |
| Amazon Basics All Day Allergy Relief 10 mg 72288-0013-40 | Amazon.com | 40 capsules | — | — | FDA listed | — |
| Zyrtec Allergy Cetirizine HCl 10 mg 67414-0013-01 | Jones | 12 capsules | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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
Age at onset
Reporter sex
Male · 28%
Female · 72%
Unknown · 0%
Serious outcomes
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 |
|---|---|---|---|
| 61474-4307-01 You're viewing this | 12000 CAPSULE, LIQUID FILLED in 1 CARTON (61474-4307-1) | — | Active |
🧭 About this NDC listing & data coverage
Listed for further processing / repackaging
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Catalent Ontario Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
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 | — Not published for this NDC No photo available yet for this listing. |
| 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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 61474-4307-1, 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: 61474-4307-01, written without dashes as 61474430701. 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 61474-4307-01, the first segment (61474) is the labeler code FDA assigned to Catalent Ontario Limited; the middle segment (4307) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Catalent Ontario Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Catalent Ontario Limited 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.
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 FDA label FDA SPL
The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.