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Cetirizine Hydrochloride 10 mg Tablet, Film Coated, 100-count — NDC 00378-3637-01 package photo

Cetirizine Hydrochloride 10 mg Tablet, Film Coated, 100-count

by Mylan Pharmaceuticals Inc. · 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01)
NDC 00378-3637-01
🏷️ FDA NDC (as labeled) 0378-3637-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0629 NADAC Per package$6.29 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2902/unit — full pricing hub ↓
Also comes in: 500 tablets 00378-3637-05
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

⚠️
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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 0378-3637-01
Product NDC 0378-3637
11-digit billing NDC 00378363701
NCPDP billing unit EA — each (per item)
RxCUI 1014676, 1014678
UNII 64O047KTOA
Application # ANDA076677
SPL Set ID 487ae0f0-320c-4534-b9e2-0e215f167cea
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 2007-12-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance CETIRIZINE HYDROCHLORIDE
GPI-14 41550020100320
GPI class Cetirizine HCl
GCN Seq No 017037
GCN 49291
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 10 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 0378-3637-01 — a 4-4-2 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 labeler segment → 00378-3637-01. 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

LabelerMylan Pharmaceuticals Inc.
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA076677 (ANDA)
Labeler code00378
First marketedDec 2007
Product typeHuman Otc Drug
Portfolio473 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 10 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
  • 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
ShapeRound
ImprintM;C37
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • 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 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statesAnhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

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 $0.063 $6.29 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2902 $29.02 / 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 $0.076 $0.061
▼ Down 17% 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 10 mgthis 00378-3637-01 Mylan 100 tablets $0.063 — Availability likely —
Cetirizine 10 mg 00904-7510-61 Major 1 tablet $0.063 — Availability likely —
Cetirizine Hydrochloride 10 mg 16571-0402-10 Rising 100 tablets $0.063 — Availability likely —
Cetirizine Hydrochloride (Allergy) 10 mg 16714-0799-01 NorthStar 30 tablets $0.063 — Availability likely —
good neighbor pharmacy all day allergy 10 mg 24385-0998-65 Amerisource 30 tablets $0.063 — Availability likely —
cetirizine hydrochloride 10 mg 45802-0919-39 Padagis 30 tablets $0.063 — Availability likely —
Cetirizine Hydrochloride Tablets,10 mg 49483-0692-50 TIME 500 tablets $0.063 — Availability likely —
Cetirizine Hydrochloride 10 mg 51079-0597-20 Mylan 1 tablet $0.063 — Availability likely —
Cetirizine Hydrochloride 10 mg 51660-0939-01 Ohm 100 tablets $0.063 — Availability likely —
Cetirizine Hydrochloride (Allergy) 10 mg 68001-0436-04 BluePoint 30 tablets $0.063 — Availability likely —
Allergy Relief 10 mg 69230-0304-01 Camber 100 tablets $0.063 — Availability likely —
Cetirizine Hydrochloride 10 mg 70000-0047-01 LEADER/ 365 tablets $0.063 — Availability likely —
leader all day allergy 10 mg 70000-0380-01 Cardinal 1 tablet $0.063 — Availability likely —
Cetirizine hydrochloride 10 mg 70010-0163-05 Granules 500 tablets $0.063 — Availability likely —
Allergy Relief 10 mg 70677-1047-01 Strategic 14 tablets $0.063 — Availability likely —
Allergy Relief 10 mg 70677-1241-01 Strategic 120 tablets $0.063 — Availability likely —
Cetirizine HCl 10 mg 70677-1279-01 Strategic 14 tablets $0.063 — Availability likely —
Allergy Relief 10 mg 83324-0091-14 CHAIN 14 tablets $0.063 — Availability likely —
Cetirizine 10 mg 00904-6717-61 Major 1 tablet $0.064 — Discontinued +2%
All Day Allergy Relief 10 mg 70677-0057-01 Strategic 14 tablets $0.064 — FDA listed +2%
Good Sense all day allergy 10 mg 00113-9458-13 L. 1 tablet $0.064 — Discontinued +2%
cetirizine hydrochloride 10 mg 70677-1007-01 Strategic 30 tablets $0.065 — Discontinued +4%
Wal-Zyr 10 mg 00363-0606-03 Walgreens 30 tablets — — FDA listed —
Allergy Relief 10 mg 00363-1794-38 WALGREENS 5 tablets — — FDA listed —
allergy relief 10 mg 00363-4101-13 Walgreen 1 tablet — — Discontinued —
Hives Relief 10 mg 00363-6340-13 WALGREEN 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 00363-9602-09 WALGREEN 30 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 00615-8479-39 NCS 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 00781-1684-01 Sandoz 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 10135-0762-01 Marlex 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 10267-3579-01 Contract 100 tablets — — FDA listed —
Up and Up Allergy Relief 10 mg 11673-0502-06 Target 70 tablets — — Discontinued —
all day allergy 10 mg 11822-1002-01 Rite 1 tablet — — FDA listed —
Cetirizine Hydrochloride 10 mg 14445-0152-01 Indoco 100 tablets — — FDA listed —
signature care allergy relief 10 mg 21130-0090-39 Safeway 30 tablets — — Discontinued —
Cetirizine Hydrochloride (Allergy) 10 mg 21130-0098-23 Better 120 tablets — — FDA listed —
allergy relief 10 mg 21130-0425-95 Safeway 45 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 21130-0640-03 SAFEWAY 30 tablets — — FDA listed —
Allergy Relief 10 mg 21130-0712-03 BETTER 30 tablets — — FDA listed —
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) 25000-0160-03 MARKSANS 30 tablets — — FDA listed —
Cetirizine Hydrochloride Tablets, 10 mg 25000-0220-03 MARKSANS 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 30142-0172-09 KROGER 30 tablets — — FDA listed —
TopCare All Day Allergy 10 mg 36800-0458-06 Topco 70 tablets — — Discontinued —
allergy relief 10 mg 37808-0583-06 H 70 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 37835-0611-14 Bi-Mar 14 tablets — — FDA listed —
Allergy Relief 10 mg 41163-0197-08 United 120 tablets — — FDA listed —
Equaline all day allergy 10 mg 41163-0458-39 United 30 tablets — — FDA listed —
Allergy 10 mg 41226-0692-14 Kroger 70 tablets — — FDA listed —
24 hour allergy 10 mg 41250-0458-13 Meijer 1 tablet — — Discontinued —
CareOne Allergy Relief 10 mg 41520-0781-06 American 70 tablets — — FDA listed —
All Day Allergy 10 mg 42507-0458-39 HyVee 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 43598-0183-31 Dr. 300 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 43598-0811-05 Dr. 500 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 48433-0017-20 Safecor 1 tablet — — FDA listed —
equate allergy relief 10 mg 49035-0458-66 Wal-Mart 1 tablet — — FDA listed —
Cetirizine 10 mg 50090-5510-01 A-S 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 50090-6168-01 A-S 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 50090-6170-00 A-S 1440 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 50090-6538-01 A-S 30 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 50090-6679-00 A-S 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 50090-6950-00 A-S 30 tablets — — FDA listed —
Good Sense all day allergy 10 mg 50090-7064-01 A-S 30 tablets — — FDA listed —
Good Sense all day allergy 10 mg 50090-7065-00 A-S 30 tablets — — FDA listed —
Cetirizine 10 mg 50090-7594-00 A-S 30 tablets — — FDA listed —
Zyrtec 1s Blister 10 mg 50269-0014-01 JC 1 tablet — — FDA listed —
Zyrtec 2s Blister 10 mg 50269-0019-02 JC 2 tablets — — FDA listed —
Zyrtec Allergy 10 mg 50269-0973-01 JC 1 tablet — — FDA listed —
Cetirza 10 mg 50332-0154-02 HART 30 tablets — — FDA listed —
ZYRTEC Hives 10 mg 50580-0116-30 Kenvue 30 tablets — — FDA listed —
Zyrtec Allergy 10 mg 50580-0726-03 Kenvue 1 tablet — — FDA listed —
Zyrtec Allergy 50580-0752-01 Kenvue 50 tablets — — FDA listed —
CVS Cetirizine Hydrochloride 10 mg 51316-0182-10 CVS 365 tablets — — FDA listed —
Cetirizine 10 mg 51316-0764-65 CVS 365 tablets — — FDA listed —
Allergy Relief 10 mg 51316-0806-30 CVS 30 tablets — — FDA listed —
Cetirizine 10 mg 51655-0194-26 Northwind 90 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 51655-0801-52 Northwind 30 tablets — — FDA listed —
Cetirizine Hydrochloride Tablets,10 mg 51655-0842-26 Northwind 90 tablets — — FDA listed —
CAREALL Cetirizine HCl 10 mg 51824-0076-01 New 30 tablets — — Discontinued —
CAREALL Allergy Relief 10 mg 51824-0104-30 New 30 tablets — — FDA listed —
Zyrtec Allergy 10 mg 53209-5001-01 Morning 1 tablet — — FDA listed —
Medline 10 mg 53329-0033-33 Medline 30 tablets — — FDA listed —
Allergy Relief 10 mg 53943-0130-13 DISCOUNT 30 tablets — — FDA listed —
Allergy Relief 10 mg 53943-0194-13 DISCOUNT 90 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 53943-0519-30 Discount 30 tablets — — FDA listed —
Allergy Relief 10 mg 54257-0270-02 Magno-Humphries, 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 55111-0351-04 Dr.Reddy's 120 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 55111-0699-04 Dr.Reddy's 120 tablets — — FDA listed —
Cetirizine 10 mg 55154-0194-00 Cardinal 1 tablet — — FDA listed —
Cetirizine Hydrochloride 10 mg 55154-5399-00 Cardinal 1 tablet — — FDA listed —
Cetirizine 10 mg 55154-8081-00 Cardinal 1 tablet — — Discontinued —
Cetirizine Hydrochloride 10 mg 55289-0995-07 PD-Rx 7 tablets — — FDA listed —
Exchange select all day allergy 10 mg 55301-0076-39 Army 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 55319-0939-30 FAMILY 30 tablets — — FDA listed —
Allergy Relief 10 mg 55319-0962-05 Family 5 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 55681-0073-03 TWIN 300 tablets — — FDA listed —
Cetirizine Hydrochloride 10 Mg 55681-0302-03 TWIN 300 tablets — — FDA listed —
All Day Allergy Relief 10 mg 55910-0039-45 Dolgencorp, 45 tablets — — FDA listed —
Allergy Relief All Day 10 mg 55910-0129-45 Dolgencorp, 45 tablets — — FDA listed —
All Day Allergy Relief 10 mg 55910-0269-58 DOLGENCORP, 45 tablets — — FDA listed —
dg health all day allergy 10 mg 55910-0458-39 Dolgencorp 30 tablets — — FDA listed —
rexall all day allergy relief 10 mg 55910-0699-66 Dolgencorp, 14 tablets — — FDA listed —
Allergy Relief 10 mg 55910-0930-45 Dolgencorp, 45 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 56062-0939-30 Publix 30 tablets — — FDA listed —
Allergy Relief 10 mg 57344-0194-01 AAA 14 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 57483-0190-14 INNOVUS 365 tablets — — FDA listed —
Crcle Cetirizine Hydrochloride 10 mg 57483-0250-01 Innovus 365 tablets — — FDA listed —
Cetirizine HCl 10 mg 57896-0992-01 GERI-CARE 100 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 58602-0445-01 Aurohealth 14 tablets — — FDA listed —
Cetirizine Hydrochloride (Hives Relief) 10 mg 58602-0447-09 Aurohealth 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 58602-0812-04 Aurohealth 100 tablets — — FDA listed —
Cetirizine Hydrochloride (Hives Relief) 10 mg 58602-0813-04 Aurohealth 10 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 58602-0823-09 Aurohealth 30 tablets — — Discontinued —
Cetirizine Hydrochloride (Allergy) 10 mg 58602-0861-40 Aurohealth 500 tablets — — FDA listed —
All Day Allergy Relief 10 mg 59726-0129-03 P 300 tablets — — Discontinued —
All Day Allergy Relief 10 mg 59726-0806-05 P 5 tablets — — FDA listed —
Allergy Relief Indoor and Outdoor Allergies 10 mg 59779-0458-06 CVS 70 tablets — — Discontinued —
Cetirizine Hydrochloride 10 mg 60760-0886-30 St. 30 tablets — — FDA listed —
Allergy Relief 10 mg 61504-0194-14 Amerifoods 30 tablets — — FDA listed —
All Day Allergy Relief 10 mg 62011-0384-01 Strategic 14 tablets — — Discontinued —
Cetirizine hydrochloride 10 mg 62207-0764-49 Granules 1000 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 63187-0110-30 Proficient 30 tablets — — FDA listed —
Quality Choice Cetirizine Hydrochloride 10 mg 63868-0132-14 Chain 14 tablets — — FDA listed —
Allergy Relief 10 mg 63868-0665-14 CHAIN 14 tablets — — FDA listed —
Allergy Relief 10 mg 63941-0194-01 VALU 14 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 63941-0939-30 Valu 30 tablets — — FDA listed —
kirkland signature aller tec allergy 10 mg 63981-0458-00 Costco 1 tablet — — Discontinued —
welby allergy relief 10 mg 64024-0499-39 Aldi 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 65162-0046-03 Amneal 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 Mg 66424-0564-01 SDA 100 tablets — — FDA listed —
Zyrtec Allergy, Lil Drug Store 10 mg 66715-9811-01 Lil' 1 tablet — — FDA listed —
Allergy Relief 10 mg 67091-0351-14 WinCo 14 tablets — — FDA listed —
Allergy Relief 10 mg 67091-0494-14 WINCO 30 tablets — — FDA listed —
Zyrtec Allergy 10 mg 67296-1484-03 RedPharm 30 tablets — — FDA listed —
Zyrtec Allergy 10 mg 67751-0192-01 Navajo 1 tablet — — FDA listed —
Allergy Relief 10 mg 68016-0294-14 CHAIN 14 tablets — — Discontinued —
Cetirizine Hydrochloride 10 mg 68016-0939-30 Chain 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 68071-1964-01 NuCare 10 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 68071-2571-07 NuCare 7 tablets — — FDA listed —
Members Mark Allergy Relief 10 mg 68196-0413-79 Sam's 200 tablets — — FDA listed —
CABINET Allergy Relief 10 mg 68210-0119-00 Spirit 100 tablets — — FDA listed —
Allergy Relief 10 mg 68210-4159-01 Prodose, 14 tablets — — FDA listed —
Allergy Relief 10 mg 68210-4219-01 Spirit 120 tablets — — FDA listed —
Allergy Relief 10 mg 68210-4230-01 Spirit 120 tablets — — FDA listed —
Berkley And Jensen All Day Allergy 10 mg 68391-0400-01 BJWC 200 tablets — — FDA listed —
Good Sense all day allergy 10 mg 68788-4023-03 Preferred 30 tablets — — FDA listed —
cetirizine hydrochloride 10 mg 68788-4072-03 Preferred 30 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 68788-8204-00 Preferred 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 68788-8435-03 Preferred 30 tablets — — FDA listed —
Allergy Relief 10 mg 68998-0194-02 MARC 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 68998-0939-30 Marc 30 tablets — — FDA listed —
Allergy Relief 10 mg 69168-0396-03 Allegiant 250 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 69452-0465-81 Bionpharma 400 tablets — — FDA listed —
Pentrexcilina Day time 10 mg 69729-0137-14 OPMX 14 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 69729-0139-14 OPMX 14 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 69842-0237-01 CVS 14 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 69848-0006-09 Granules 90 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 70692-0139-14 Strive 14 tablets — — FDA listed —
RIGHT REMEDIES ALL-DAY Allergy Relief 10 mg 70692-0180-14 Strive 14 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 71141-0133-32 LIDL 14 tablets — — FDA listed —
Allergy Relief 10 mg 71141-0294-14 LIDL 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 71205-0164-15 Proficient 15 tablets — — FDA listed —
cetirizine hydrochloride 10 mg 71205-0207-06 Proficient 6 tablets — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 71205-0700-10 Proficient 10 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 71205-0709-06 Proficient 6 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 71335-0300-01 Bryant 30 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 71335-9612-01 Bryant 30 tablets — — FDA listed —
Allergy Relief 10 mg 71335-9733-01 Bryant 30 tablets — — FDA listed —
Cetirizine 10 mg 71610-0123-60 Aphena 90 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 71610-0821-30 Aphena 30 tablets — — FDA listed —
cetirizine hydrochloride 10 mg 71610-0862-30 Aphena 30 tablets — — FDA listed —
Allergy Relief 10 mg 72036-0194-01 HARRIS 14 tablets — — FDA listed —
Allergy Relief 10 mg 72090-0028-20 Pioneer 200 tablets — — FDA listed —
Allergy Relief 10 mg 72090-0059-20 Pioneer 200 tablets — — FDA listed —
Cetirizine 10 mg 72162-2162-02 Bryant 300 tablets — — FDA listed —
cetirizine hydrochloride 10 mg 72162-2173-02 Bryant 300 tablets — — FDA listed —
basic care all day allergy 10 mg 72288-0411-39 Amazon.com 30 tablets — — FDA listed —
Amazon Basic Care All Day Allergy Relief 10 mg 72288-0691-09 Amazon.com 30 tablets — — FDA listed —
Allergy Relief 10 mg 72476-0194-01 RETAIL 14 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 72476-0764-03 RETAIL 30 tablets — — FDA listed —
Curist Allergy Relief 10 mg 72559-0003-02 Little 30 tablets — — FDA listed —
Cetirizine HCl 10 mg 72657-0129-03 GLENMARK 300 tablets — — FDA listed —
Cetirizine HCl 72657-0131-89 GLENMARK 90 tablets — — FDA listed —
cetirizine hydrochloride 10 mg 72789-0343-30 PD-Rx 30 tablets — — FDA listed —
cetirizine hydrochloride 10 mg 72789-0458-10 PD-Rx 10 tablets — — FDA listed —
Zyrtec Allergy 10 mg 73097-0016-20 Savings 1 tablet — — FDA listed —
Cetirizine Hydrochloride 10 Mg 73581-0202-01 YYBA 100 tablets — — FDA listed —
Cetirizine HCL 10 mg 79481-7640-06 Meijer 60 tablets — — FDA listed —
betr remedies all day allergy relief 10 mg 80267-0409-95 Live 45 tablets — — FDA listed —
Cetirizine hydrochloride 10 mg 80513-0731-05 Advanced 500 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 81469-0353-01 First 100 tablets — — FDA listed —
Allergy Relief 10 mg 81522-0194-04 FSA 45 tablets — — FDA listed —
Goodnow Allergy Relief 10 mg 82501-0422-01 Gobrands, 30 tablets — — FDA listed —
ValuMeds 24-Hour Allergy Relief 10 mg 82725-1003-01 Cabinet 300 tablets — — FDA listed —
ValuMeds All Day Allergy Cetirizine Hydrochloride 10 mg 82725-1103-01 Cabinet 300 tablets — — FDA listed —
Cabinet Allergy Relief Refill Cetirizine HCI 10 mg 82725-3003-02 Cabinet 40 tablets — — FDA listed —
Cabinet All Day Allergy Relief 10 mg 82725-3103-03 Cabinet 300 tablets — — FDA listed —
Goodmeds All Day Allergy Relief Cetirizine HCl 10 mg 82725-4103-02 Cabinet 500 tablets — — FDA listed —
Cetirizine 10 mg 83939-0003-00 VERITYRX, 1 tablet — — FDA listed —
Cetirizine Hydrochloride 10 mg 83939-0004-01 VERITYRX, 1 tablet — — FDA listed —
Allergy Relief 10 mg 84324-0001-01 NUVICARE 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 85293-0001-01 Umasuto, 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 85766-0045-05 Sportpharm 500 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 85766-0149-01 Sportpharm 100 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 85766-0205-12 Sportpharm 120 tablets — — FDA listed —
Dr Simi Cetirizine Hydrochloride 10 mg 85786-0203-30 Farmacias 30 tablets — — FDA listed —
Allergy Relief 10 mg 85828-0194-14 Grocery 30 tablets — — FDA listed —
Cetirizine hydrochloride - HIVES 10 mg 70010-0293-10 Granules 1000 tablets — — FDA listed —
Zyrtec Allergy 10 mg 85237-2960-01 Select 1 tablet — — FDA listed —
Cetirizine Hydrochloride 10 mg 71141-0194-14 LIDL 30 tablets — — FDA listed —
GOOD REMEDIES All Day Allergy Relief 10 mg 70692-0801-43 Strive 14 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

🏛️
2007
On the market since
Dec 2007
📍
2026
Currently FDA-listed
19 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 00378-3637-01, 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
116.7K
Units reimbursed last 4 qtrs
4.3M
Gross reimbursed last 4 qtrs
$1.24M
Avg / prescription
$10.66
Avg / unit
$0.2902
Latest quarter Q4 2025
26.9KRx
Medicaid pays / ea
$0.2902
gross reimbursed
vs
NADAC / ea
$0.0629
acquisition cost
=
Spread
+$0.2273
+361% 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 ⓘ
65% FFS 35% MCO
Fee-for-service · 75,724 Rx Managed care · 40,957 Rx
State Medicaid map
Alaska: no data reported AK Maine: 23,430 units · 1,680 per 100k residents ME Washington: 18,031 units · 231 per 100k residents WA Idaho: 11,839 units · 603 per 100k residents ID Montana: 1,598 units · 141 per 100k residents MT North Dakota: 310 units · 39.6 per 100k residents ND Minnesota: 7,286 units · 127 per 100k residents MN Wisconsin: 16,865 units · 285 per 100k residents WI Michigan: 42,024 units · 419 per 100k residents MI New York: 2,118,247 units · 10,823 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,440 units · 103 per 100k residents NH Oregon: 4,895 units · 116 per 100k residents OR Nevada: 34,670 units · 1,085 per 100k residents NV Wyoming: 420 units · 71.9 per 100k residents WY South Dakota: 1,830 units · 199 per 100k residents SD Iowa: 8,313 units · 259 per 100k residents IA Illinois: 29,473 units · 235 per 100k residents IL Indiana: 25,885 units · 377 per 100k residents IN Ohio: 12,218 units · 104 per 100k residents OH Pennsylvania: 252,175 units · 1,946 per 100k residents PA New Jersey: 254,079 units · 2,735 per 100k residents NJ Massachusetts: 3,997 units · 57.1 per 100k residents MA California: 562,508 units · 1,444 per 100k residents CA Utah: 8,571 units · 251 per 100k residents UT Colorado: 628 units · 10.7 per 100k residents CO Nebraska: 3,066 units · 155 per 100k residents NE Missouri: 27,200 units · 439 per 100k residents MO Kentucky: 91,901 units · 2,031 per 100k residents KY West Virginia: 15,254 units · 862 per 100k residents WV Virginia: 38,622 units · 443 per 100k residents VA Maryland: 85,576 units · 1,385 per 100k residents MD Connecticut: 46,441 units · 1,284 per 100k residents CT Rhode Island: 4,927 units · 450 per 100k residents RI Arizona: 21,673 units · 292 per 100k residents AZ New Mexico: 5,405 units · 256 per 100k residents NM Kansas: 12,244 units · 416 per 100k residents KS Arkansas: 17,793 units · 580 per 100k residents AR Tennessee: 22,965 units · 322 per 100k residents TN North Carolina: 15,017 units · 139 per 100k residents NC South Carolina: 6,956 units · 129 per 100k residents SC Delaware: 3,135 units · 304 per 100k residents DE Oklahoma: 3,480 units · 85.9 per 100k residents OK Louisiana: 123,966 units · 2,710 per 100k residents LA Mississippi: 24,898 units · 847 per 100k residents MS Alabama: 4,276 units · 83.7 per 100k residents AL Georgia: 64,042 units · 581 per 100k residents GA D.C.: 29,643 units · 4,366 per 100k residents DC Hawaii: no data reported HI Texas: 169,340 units · 555 per 100k residents TX Florida: 5,336 units · 23.6 per 100k residents FL
Units reimbursed · per 100k residents
10.710,823
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 New York 10,823 /100k
2 D.C. 4,366 /100k
3 New Jersey 2,735 /100k
4 Louisiana 2,710 /100k
5 Kentucky 2,031 /100k
6 Pennsylvania 1,946 /100k
7 Maine 1,680 /100k
8 California 1,444 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page00378-3637-01 116,681 Rx · $1,243,375
500 tablets00378-3637-05 72,054 Rx · $711,431
Drug total (last 4 qtrs): 188,735 Rx · 6,865,997 units · $1,954,806 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Per unit Per pack Marketing startStatus
00378-3637-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01) $0.0629 / ea $6.29 2007-12-27 Active
00378-3637-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05) $0.0629 / ea $31.47 2007-12-27 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0629 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 62% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00378-3637-01?
NDC 00378-3637-01 is a 100-count package — 100 tablet, film coated in 1 bottle, plastic.
What is the difference between NDC 00378-3637-01 and NDC 00378-3637-05?
Both are Cetirizine Hydrochloride 10 mg Tablet, Film Coated — the drug itself is identical. NDC 00378-3637-01 is the 100-count package, while NDC 00378-3637-05 is the 500 tablets package.
What NDC number is used to bill for this package of Cetirizine Hydrochloride 10 mg Tablet, Film Coated?
Bill NDC 00378-3637-01 — the 11-digit billing format is 00378363701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 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 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 151 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 • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • 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.

🧪 Active Ingredient 10 words ▾

Active Ingredient (in each tablet) Cetirizine hydrochloride USP, 5 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00378-3635-01 · Mylan 00378-3750-01 · Mylan →
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.