ZYRTEC Cetirizine Hydrochloride 10 mg Capsule, Liquid Filled, 40-count
by Johnson & Johnson Consumer Inc. · 1 BOTTLE in 1 PACKAGE (50580-779-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 50580-0779-40
🏷️ FDA NDC (as labeled)
50580-779-40
billing pads the product segment with a zero
This package
Contains40-count
Pack sizes4 compare ↓
OTC
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jan 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
50580-779-40
Product NDC
50580-779
11-digit billing NDC
50580077940
NCPDP billing unit
EA — each (per item)
Application #
NDA022429
Established class (EPC)
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jan 2026)
Route
ORAL
Dosage form
CAPSULE, LIQUID FILLED
Substance
CETIRIZINE HYDROCHLORIDE
GCN Seq No
066093
GCN
28274
HICL code
006544
Ingredient (HICL)
Cetirizine Hcl
HIC1 code
Z
Therapeutic class — broad (HIC1)
Body As A Whole
HIC2 code
Z2
Therapeutic class — intermediate (HIC2)
Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code
Z2Q
Therapeutic class — specific (HIC3)
Antihistamines - 2Nd Generation
AHFS code
04:08.00.00
AHFS class
Second Generation Antihistamines
FDB label name
ZYRTEC 10 MG LIQUID GELS
FDB brand name
Zyrtec
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50580-779-40 — 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 → 50580-0779-40. 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
LabelerJohnson & Johnson Consumer Inc.
Application holderBIONPHARMA INC
FDA applicationNDA022429 (NDA)
Labeler code50580
Product typeHuman Otc Drug
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
Label name ZYRTEC 10 MG LIQUID GELS Ingredient Cetirizine Hcl
📖 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?
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.
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 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 |
|---|---|---|---|---|---|---|
| Cetirizine HCl 10 mg 46122-0613-63 | AMERISOURCE | 25 capsules | $0.195 | — | Availability likely | — |
| Good Sense All Day Allergy 10 mg 00113-0981-63 | L. | 25 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 00363-0068-12 | WALGREEN | 40 capsules | — | — | FDA listed | — |
| 24 Hour Allergy 10 mg 00363-1219-15 | Walgreens | 40 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 00363-6341-15 | WALGREEN | 40 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 11673-0242-15 | TARGET | 40 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 11673-0650-15 | TARGET | 40 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 11822-4228-01 | RITE | 25 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 21130-0099-97 | Better | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 21130-0364-25 | Safeway, | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 30142-0995-25 | KROGER | 25 capsules | — | — | FDA listed | — |
| top care all day allergy 10 mg 36800-0180-09 | Topco | 65 capsules | — | — | FDA listed | — |
| topcare all day allergy 10 mg 36800-0448-09 | Topco | 65 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 36800-0542-15 | TOP | 40 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 36800-0543-15 | TOP | 40 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 37808-0564-25 | H | 25 capsules | — | — | FDA listed | — |
| all day allergy 10 mg 41163-0219-08 | SUPERVALU | 12 capsules | — | — | FDA listed | — |
| 24 hour allergy 10 mg 41250-0618-63 | Meijer | 25 capsules | — | — | FDA listed | — |
| All Day Allergy 10 mg 41520-0212-25 | Care | 25 capsules | — | — | FDA listed | — |
| CareOne Allergy Relief 10 mg 41520-0715-63 | American | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 42681-0056-01 | Whole | 30 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 46122-0815-64 | AMERISOURCE | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 49035-0841-25 | EQUATE | 25 capsules | — | — | FDA listed | — |
| ZYRTEC Allergy 10 mg 50580-0786-12 | Kenvue | 12 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 51316-0064-25 | CVS | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 51316-0810-05 | CVS | 40 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 51316-0811-25 | CVS | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 53943-0219-40 | DISCOUNT | 40 capsules | — | — | FDA listed | — |
| dg health all day allergy 10 mg 55910-0710-49 | Dolgencorp, | 40 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 55910-0784-15 | DOLGENCORP | 40 capsules | — | — | FDA listed | — |
| dg health all day allergy 10 mg 55910-0934-49 | Dolgencorp | 40 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 56062-0064-25 | Publix | 25 capsules | — | — | FDA listed | — |
| allergy relief 10 mg 56062-0111-63 | Publix | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 56062-0452-86 | PUBLIX | 25 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 58602-0716-16 | Aurohealth | 65 capsules | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 10 mg 58602-0806-04 | Aurohealth | 12 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 | — |
| Cetirizine HCl 10 mg 59450-0020-15 | KROGER | 40 capsules | — | — | FDA listed | — |
| All Day Allergy Relief 10 mg 59726-0064-12 | P | 12 capsules | — | — | FDA listed | — |
| All Day Allergy Relief 10 mg 59726-0741-12 | P | 12 capsules | — | — | FDA listed | — |
| All Day Allergy Relief 10 mg 63868-0433-25 | CHAIN | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 69168-0392-25 | Allegiant | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 69452-0265-15 | Bionpharma | 40 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 69452-0479-88 | Bionpharma | 65 capsules | — | — | FDA listed | — |
| basic care all day allergy 10 mg 72288-0007-49 | Amazon.com | 40 capsules | — | — | FDA listed | — |
| basic care all day allergy 10 mg 72288-0980-49 | Amazon.com | 40 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 72476-0064-25 | Care | 25 capsules | — | — | FDA listed | — |
| careone allergy relief 10 mg 72476-0623-63 | Retail | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 79481-0670-02 | Meijer | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 79481-0671-02 | Meijer | 25 capsules | — | — | FDA listed | — |
| 24 hour allergy 10 mg 79481-0981-00 | Meijer, | 25 capsules | — | — | Discontinued | — |
| All Day Allergy 10 mg 79903-0084-25 | WALMART | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 79903-0344-25 | WALMART | 25 capsules | — | — | FDA listed | — |
| Allergy Relief 10 mg 79903-0347-25 | WALMART | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 80136-0856-23 | Northeast | 25 capsules | — | — | FDA listed | — |
| Zyrtec 10 mgthis 50580-0779-40 | Johnson | 40 capsules | — | — | Discontinued | — |
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Zyrtec (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 26%
Female · 74%
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 |
|---|---|---|---|
| 50580-0779-12 | 1 BOTTLE in 1 PACKAGE (50580-779-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2010-02-08 | Discontinued by firm |
| 50580-0779-25 | 1 BOTTLE in 1 PACKAGE (50580-779-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2010-02-08 | Discontinued by firm |
| 50580-0779-40 You're viewing this | 1 BOTTLE in 1 PACKAGE (50580-779-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2010-02-08 | Discontinued by firm |
| 50580-0779-65 | 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-779-65) | 2010-02-08 | Discontinued by firm |
Pack size FAQ
What quantity is in NDC 50580-0779-40?
NDC 50580-0779-40 is a 40-count package — 1 bottle in 1 package / 40 capsule, liquid filled in 1 bottle.
What is the difference between NDC 50580-0779-40 and NDC 50580-0779-12?
Both are ZYRTEC Cetirizine Hydrochloride 10 mg Capsule, Liquid Filled — the drug itself is identical. NDC 50580-0779-40 is the 40-count package, while NDC 50580-0779-12 is the 12 capsules package.
What NDC number is used to bill for this package of ZYRTEC Cetirizine Hydrochloride 10 mg Capsule, Liquid Filled?
Bill NDC 50580-0779-40 — the 11-digit billing format is 50580077940. 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
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| 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
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.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 50580-779-40, 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: 50580-0779-40, written without dashes as 50580077940. 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 50580-0779-40, the first segment (50580) is the labeler code FDA assigned to Johnson & Johnson Consumer Inc.; the middle segment (0779) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 12 capsules (50580-0779-12), 25 capsules (50580-0779-25), 65 capsules (50580-0779-65). 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?
Johnson & Johnson Consumer Inc. 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.
📄 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.
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.