Cetirizine HCl 10 mg Capsule, 25-count
by Northeast Pharma · 1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTIC
NDC 80136-0856-23
🏷️ FDA NDC (as labeled)
80136-856-23
billing pads the product segment with a zero
OTC
Brand
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 →
🆔 Identity & classification
FDA NDC (as labeled)
80136-856-23
Product NDC
80136-856
11-digit billing NDC
80136085623
RxCUI
1014675
UNII
64O047KTOA
Application #
NDA022429
SPL Set ID
0647ef4c-8912-9f44-e063-6294a90ae3a6
Established class (EPC)
Histamine-1 Receptor Antagonist
Mechanism of action
Histamine H1 Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-09-26
Route
ORAL
Dosage form
CAPSULE
Substance
CETIRIZINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 80136-856-23 — 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 → 80136-0856-23. 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
LabelerNortheast Pharma
Application holderBIONPHARMA INC
FDA applicationNDA022429 (NDA)
Labeler code80136
First marketedSep 2023
Product typeHuman Otc Drug
Portfolio5 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
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 HCl?
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 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 HCl 10 mg 46122-0613-63 | AMERISOURCE | 25 capsules | $0.196 | — | 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 | — | — | Discontinued | — |
| 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 mgthis 80136-0856-23 | Northeast | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 56062-0495-86 | PUBLIX | 25 capsules | — | — | FDA listed | — |
| Cetirizine HCl 10 mg 51316-0900-19 | CVS | 90 capsules | — | — | FDA listed | — |
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
🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Cetirizine HCl — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cetirizine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$80.4K
Claims incl. refills
4.7K
Beneficiaries
3K
Spend / beneficiary
$26.80
Spend / claim
$16.96
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 HCl — the ingredient across all brands.
Top reported reactions
Reporter sex
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 |
|---|---|---|---|
| 80136-0856-23 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTIC | 2023-09-26 | Active |
🧭 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 | — 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.
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 80136-856-23, 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: 80136-0856-23, written without dashes as 80136085623. 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 80136-0856-23, the first segment (80136) is the labeler code FDA assigned to Northeast Pharma; the middle segment (0856) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (23) 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 Northeast Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Northeast Pharma 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 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
⏱️ Dosage and Administration ▾
Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 Do not use 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.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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.
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.
📦 Storage and Handling ▾
Other information store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light
🧪 Active Ingredient ▾
Active ingredient (in each capsule) Cetirizine HCl 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol
🎯 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.