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Cetirizine Hydrochloride 5 mg Tablet, 100-count

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE (16571-401-10)
NDC 16571-0401-10
🏷️ FDA NDC (as labeled) 16571-401-10 billing pads the product segment with a zero
OTC Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
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
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Cetirizine Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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) 16571-401-10
Product NDC 16571-401
11-digit billing NDC 16571040110
NCPDP billing unit EA — each (per item)
RxCUI 1014676
UNII 64O047KTOA
Application # ANDA077829
SPL Set ID 6493d4f6-dead-45ec-ade1-28ce624af33d
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 2009-10-01
Route ORAL
Dosage form TABLET
Substance CETIRIZINE HYDROCHLORIDE
GPI-14 41550020100310
GPI class Cetirizine HCl
GCN Seq No 024484
GCN 49292
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 CETIRIZINE HCL 5 MG TABLET
FDB brand name Cetirizine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 16571-401-10 — 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 → 16571-0401-10. 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

LabelerRising Pharma Holdings, Inc.
Application holderUNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD
FDA applicationANDA077829 (ANDA)
Labeler code16571
First marketedOct 2009
Product typeHuman Otc Drug
Portfolio525 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

Label name CETIRIZINE HCL 5 MG TABLET Ingredient Cetirizine Hcl
📗 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 →

Supplement & herbal interactions

Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:

BeerModerate WineModerate Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Cetirizine Hydrochloride (5 interactions) — ranked by severity →
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
ShapeBullet
ImprintCTN;5
Size7 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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

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

The official label also stateshypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, 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 DailyMed — ingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.052 $5.17 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2487 $24.87 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.057 $0.048
▼ Down 4% over the last 24 months.
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 mgthis 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 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

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 16571-0401-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
163.9K
Units reimbursed last 4 qtrs
5.8M
Gross reimbursed last 4 qtrs
$1.44M
Avg / prescription
$8.78
Avg / unit
$0.2487
Latest quarter Q4 2025
39.2KRx
Medicaid pays / ea
$0.2487
gross reimbursed
vs
NADAC / ea
$0.0517
acquisition cost
=
Spread
+$0.1970
+381% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
34% FFS 66% MCO
Fee-for-service · 56,301 Rx Managed care · 107,578 Rx
State Medicaid map
Alaska: 2,285 units · 312 per 100k residents AK Maine: 52,128 units · 3,737 per 100k residents ME Washington: 112,565 units · 1,441 per 100k residents WA Idaho: 9,759 units · 497 per 100k residents ID Montana: 11,626 units · 1,027 per 100k residents MT North Dakota: 3,024 units · 386 per 100k residents ND Minnesota: 210,106 units · 3,662 per 100k residents MN Wisconsin: 188,647 units · 3,192 per 100k residents WI Michigan: 176,362 units · 1,757 per 100k residents MI New York: 373,294 units · 1,907 per 100k residents NY Vermont: 15,073 units · 2,330 per 100k residents VT New Hampshire: 14,294 units · 1,020 per 100k residents NH Oregon: 76,809 units · 1,815 per 100k residents OR Nevada: 51,527 units · 1,613 per 100k residents NV Wyoming: 4,518 units · 774 per 100k residents WY South Dakota: 27,009 units · 2,939 per 100k residents SD Iowa: 41,334 units · 1,289 per 100k residents IA Illinois: 121,814 units · 971 per 100k residents IL Indiana: 107,982 units · 1,574 per 100k residents IN Ohio: 406,722 units · 3,451 per 100k residents OH Pennsylvania: 302,143 units · 2,331 per 100k residents PA New Jersey: 61,178 units · 659 per 100k residents NJ Massachusetts: 131,886 units · 1,884 per 100k residents MA California: 535,740 units · 1,375 per 100k residents CA Utah: 13,023 units · 381 per 100k residents UT Colorado: 59,601 units · 1,014 per 100k residents CO Nebraska: 31,100 units · 1,572 per 100k residents NE Missouri: 158,108 units · 2,552 per 100k residents MO Kentucky: 244,262 units · 5,397 per 100k residents KY West Virginia: 63,237 units · 3,573 per 100k residents WV Virginia: 159,599 units · 1,831 per 100k residents VA Maryland: 71,778 units · 1,161 per 100k residents MD Connecticut: 51,129 units · 1,414 per 100k residents CT Rhode Island: 41,661 units · 3,805 per 100k residents RI Arizona: 108,781 units · 1,464 per 100k residents AZ New Mexico: 30,974 units · 1,465 per 100k residents NM Kansas: 56,539 units · 1,923 per 100k residents KS Arkansas: 730 units · 23.8 per 100k residents AR Tennessee: 83,444 units · 1,171 per 100k residents TN North Carolina: 278,440 units · 2,570 per 100k residents NC South Carolina: 101,971 units · 1,898 per 100k residents SC Delaware: 15,112 units · 1,466 per 100k residents DE Oklahoma: 119,421 units · 2,946 per 100k residents OK Louisiana: 149,446 units · 3,267 per 100k residents LA Mississippi: 80,739 units · 2,746 per 100k residents MS Alabama: 121,287 units · 2,374 per 100k residents AL Georgia: 124,078 units · 1,125 per 100k residents GA D.C.: 21,044 units · 3,099 per 100k residents DC Hawaii: 25,610 units · 1,785 per 100k residents HI Texas: 459,148 units · 1,505 per 100k residents TX Florida: 76,003 units · 336 per 100k residents FL
Units reimbursed · per 100k residents
23.85,397
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 5,397 /100k
2 Rhode Island 3,805 /100k
3 Maine 3,737 /100k
4 Minnesota 3,662 /100k
5 West Virginia 3,573 /100k
6 Ohio 3,451 /100k
7 Louisiana 3,267 /100k
8 Wisconsin 3,192 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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

Fatigue18,984
Pain16,031
Rash13,524
Headache12,772
Pruritus12,668
Nausea11,971
Dyspnoea11,250

Age at onset

Neonate197
Infant363
Child2,567
Adolescent1,715
Adult22,738
Elderly9,926

Reporter sex

166,310 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization38,192
Disabling11,004
Death10,839
Life-threatening9,684
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 14,960 7,068
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
16571-0401-10 You're viewing this 100 TABLET in 1 BOTTLE (16571-401-10) 2009-10-01 Active

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 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 67 words ▾

Directions 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

⚠️ Warnings 145 words ▾

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 drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary. 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 Poison Control Center right away.

(1-800-222-1222)

🧪 Active Ingredient 10 words ▾

Active Ingredient (in each tablet) Cetirizine HCl USP 5 mg

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

🎯 Purpose 2 words ▾

Purpose Antihistimine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16571-0261-01 · Rising 16571-0402-10 · Rising →
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.