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Cetirizine Hydrochloride 5 mg Tablet, 100-count — NDC 16571-0401-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cetirizine Hydrochloride 5 mg Tablet, 100-count — NDC 16571-401-10 (Billing 16571-0401-10)

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Cetirizine Hydrochloride 5 mg Tablet from Rising Pharma Holdings, Inc., marketed since Oct 2009 and currently FDA-listed; retail pharmacies pay about $0.0476 per tablet (NADAC). It is this product's only package size.

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 ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 16571-401-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
16571 labeler · 401 product · 10 package
Package marketed since
Oct 1, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 1657140110 9
Medicaid fills, this package
161,835 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
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
Lots / codes: Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT · reported Jul 29, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 024484
  • GCN: 49292
  • GPI-14 (Medi-Span): 41550020100310
  • HICL (First Databank): 006544
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1014676
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.

Clinical

Label name CETIRIZINE HCL 5 MG TABLET 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
  • It relieves allergy symptoms. Over-the-counter versions ease runny nose, sneezing, itchy, watery eyes and an itchy nose or throat from hay fever. Specific products treat hives, yea...
  • It can. Drowsiness was reported, and it was more common at higher doses in children. Be careful driving or using machinery until you know how it affects you, and avoid alcohol.
  • The oral solution can be taken with or without food. Food slightly delays how fast it works but does not change how much your body absorbs.
  • Check with me first if you take sedatives or tranquilizers, since they can add to drowsiness. The label found no significant interactions with azithromycin, pseudoephedrine, ketoco...
📖 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.

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 $0.048 $4.76 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2481 $24.81 / 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.057 $0.048
▼ Down 15% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
16571-0401-10 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2009-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 5 mg 00378-3635-01 Mylan 100 tablets $0.048 — Availability likely —
Cetirizine Hydrochloride 5 mgthis 16571-0401-10 Rising 100 tablets $0.048 — Availability likely —
Cetirizine Hydrochloride 5 mg 49483-0682-01 TIME 100 tablets $0.048 — 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 —
Cetirizine Hydrochloride 5 mg 81469-0352-01 First 100 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.

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.

🧪 Avoiding an ingredient? See Cetirizine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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.

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.

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 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

📄 Keep Out of Reach of Children 21 words ▾

keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)

📄 Questions or Comments 3 words ▾

Questions? Call 1-844-874-7464

📄 Package Label / Principal Display Panel 52 words ▾

PRINCIPAL DISPLAY PANEL-100'S COUNT Rising NDC 16571-401-10 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 100 Tablets T10 - M.L. G/1430 cetrizine-5mg-1 cetrizine-5mg-2 cetrizine-5mg-3

T20 - M.L. G/25/2188 cetrizine-5mg-4 cetrizine-5mg-5 cetrizine-5mg-6

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
161.8K
Units reimbursed last 4 qtrs
5.7M
Gross reimbursed last 4 qtrs
$1.42M
Avg / prescription
$8.77
Avg / unit
$0.2481
Latest quarter Q1 2026
32.8KRx
Medicaid pays / ea
$0.2481
gross reimbursed
vs
NADAC / ea
$0.0476
acquisition cost
=
Spread
+$0.2005
+421% 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 · 55,622 Rx Managed care · 106,213 Rx
State Medicaid map
Alaska: 1,980 units · 270 per 100k residents AK Maine: 52,726 units · 3,780 per 100k residents ME Washington: 102,655 units · 1,314 per 100k residents WA Idaho: 10,337 units · 526 per 100k residents ID Montana: 11,031 units · 974 per 100k residents MT North Dakota: 3,033 units · 387 per 100k residents ND Minnesota: 218,478 units · 3,808 per 100k residents MN Wisconsin: 190,973 units · 3,231 per 100k residents WI Michigan: 172,102 units · 1,715 per 100k residents MI New York: 371,822 units · 1,900 per 100k residents NY Vermont: 14,870 units · 2,298 per 100k residents VT New Hampshire: 14,413 units · 1,028 per 100k residents NH Oregon: 78,086 units · 1,845 per 100k residents OR Nevada: 58,319 units · 1,826 per 100k residents NV Wyoming: 4,557 units · 780 per 100k residents WY South Dakota: 27,462 units · 2,988 per 100k residents SD Iowa: 40,366 units · 1,259 per 100k residents IA Illinois: 119,721 units · 954 per 100k residents IL Indiana: 108,587 units · 1,582 per 100k residents IN Ohio: 419,289 units · 3,558 per 100k residents OH Pennsylvania: 291,678 units · 2,250 per 100k residents PA New Jersey: 58,262 units · 627 per 100k residents NJ Massachusetts: 133,137 units · 1,902 per 100k residents MA California: 534,844 units · 1,373 per 100k residents CA Utah: 12,256 units · 359 per 100k residents UT Colorado: 61,189 units · 1,041 per 100k residents CO Nebraska: 31,250 units · 1,580 per 100k residents NE Missouri: 163,856 units · 2,645 per 100k residents MO Kentucky: 238,801 units · 5,276 per 100k residents KY West Virginia: 65,751 units · 3,715 per 100k residents WV Virginia: 155,951 units · 1,789 per 100k residents VA Maryland: 73,132 units · 1,183 per 100k residents MD Connecticut: 53,338 units · 1,475 per 100k residents CT Rhode Island: 38,701 units · 3,534 per 100k residents RI Arizona: 107,398 units · 1,445 per 100k residents AZ New Mexico: 31,205 units · 1,476 per 100k residents NM Kansas: 56,718 units · 1,929 per 100k residents KS Arkansas: 1,058 units · 34.5 per 100k residents AR Tennessee: 63,890 units · 897 per 100k residents TN North Carolina: 280,448 units · 2,588 per 100k residents NC South Carolina: 99,128 units · 1,845 per 100k residents SC Delaware: 14,778 units · 1,433 per 100k residents DE Oklahoma: 111,737 units · 2,757 per 100k residents OK Louisiana: 138,516 units · 3,028 per 100k residents LA Mississippi: 79,066 units · 2,689 per 100k residents MS Alabama: 114,655 units · 2,245 per 100k residents AL Georgia: 117,222 units · 1,063 per 100k residents GA D.C.: 22,704 units · 3,344 per 100k residents DC Hawaii: 24,272 units · 1,691 per 100k residents HI Texas: 454,519 units · 1,490 per 100k residents TX Florida: 71,072 units · 314 per 100k residents FL
Units reimbursed · per 100k residents
34.55,276
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 5,276 /100k
2 Minnesota 3,808 /100k
3 Maine 3,780 /100k
4 West Virginia 3,715 /100k
5 Ohio 3,558 /100k
6 Rhode Island 3,534 /100k
7 D.C. 3,344 /100k
8 Wisconsin 3,231 /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.
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.