HomeNDC LookupIngredientsCetirizine › 72657-0128-81
Cetirizine HCl 5 mg Tablet, 120-count — NDC 72657-0128-81 package photo

Cetirizine HCl 5 mg Tablet, 120-count

by GLENMARK THERAPEUTICS INC., USA · 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE
NDC 72657-0128-81
🏷️ FDA NDC (as labeled) 72657-128-81 billing pads the product segment with a zero
This package
Contains120-count Pack sizes18 compare ↓
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 →
🚨
Active recall for this product.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0348-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72657-128-81
Product NDC 72657-128
11-digit billing NDC 72657012881
RxCUI 1014676, 1014678
UNII 64O047KTOA
UPC 0372657129350
Application # ANDA078427
SPL Set ID 04b08c52-5390-4cdb-a9e7-fca81fffdc73
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 2024-05-13
Route ORAL
Dosage form TABLET
Substance CETIRIZINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 72657-128-81 — 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 → 72657-0128-81. 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

LabelerGLENMARK THERAPEUTICS INC., USA
Application holderGLENMARK PHARMACEUTICALS INC USA
FDA applicationANDA078427 (ANDA)
Labeler code72657
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio21 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 →
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

Color White
ShapeRound
ImprintC;17
Size8 mm
ScoringNot scored
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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescolloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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 DailyMedingredient 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 eachPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 5 mg 00378-3635-01 Mylan 100 tablets $0.052 Availability likely
Cetirizine Hydrochloride 5 mg 16571-0401-10 Rising 100 tablets $0.052 Availability likely
Cetirizine Hydrochloride 5 mg 49483-0682-01 TIME 100 tablets $0.052 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 mg 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 mgthis 72657-0128-81 GLENMARK 120 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.

📊 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 — the ingredient across all brands.

Top reported reactions

Fatigue19,513
Pain16,355
Rash13,833
Headache13,203
Pruritus13,036
Nausea12,435
Dyspnoea11,672

Age at onset

Neonate198
Infant372
Child2,720
Adolescent1,800
Adult23,569
Elderly10,520

Reporter sex

174,309 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization40,128
Death11,203
Disabling11,156
Life-threatening9,913
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 14,442 0
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
72657-0128-03 1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-04 1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-08 1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-14 1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-15 1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-18 1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-24 1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-30 1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-35 1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-41 1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-45 1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-60 1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-70 1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-81 You're viewing this 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-82 2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-84 2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-86 2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE 2024-05-13 Active
72657-0128-90 1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE 2024-05-13 Active

Pack size FAQ

What quantity is in NDC 72657-0128-81?
NDC 72657-0128-81 is a 120-count package — 2 bottle in 1 carton / 60 tablet in 1 bottle.
What is the difference between NDC 72657-0128-81 and NDC 72657-0128-41?
Both are Cetirizine HCl 5 mg Tablet — the drug itself is identical. NDC 72657-0128-81 is the 120-count package, while NDC 72657-0128-41 is the 14 tablets package.
What NDC number is used to bill for this package of Cetirizine HCl 5 mg Tablet?
Bill NDC 72657-0128-81 — the 11-digit billing format is 72657012881. 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 72657-128-81, 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: 72657-0128-81, written without dashes as 72657012881. 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 72657-0128-81, the first segment (72657) is the labeler code FDA assigned to GLENMARK THERAPEUTICS INC., USA; the middle segment (0128) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (81) 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 GLENMARK THERAPEUTICS INC., USA. 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 17 other package presentations of this same product, including 14 tablets (72657-0128-41), 30 tablets (72657-0128-30), 45 tablets (72657-0128-45). 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?
GLENMARK THERAPEUTICS INC., USA 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 30 words

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 150 words

Directions Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets, USP 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 168 words

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine Ask a doctor before useif 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 • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • in rare cases, you may experience itching after stopping cetirizine.

Consult your healthcare provider if this happens. 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 (1-800-222-1222)

🧪 Active Ingredient 8 words

Cetirizine HCl 5 mg Cetirizine HCl 10 mg

🧪 Inactive Ingredients 16 words

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

🎯 Purpose 1 words

Antihistamine

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.