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Leader Childrens all day allergy Cetirizine HCl 5 mg/5mL Solution — NDC 70000-0215-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Leader Childrens all day allergy Cetirizine HCl 5 mg/5mL Solution — NDC 70000-0215-1 (Billing 70000-0215-01)

by Cardinal Health 110, LLC. dba Leader · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Leader Childrens all day allergy Cetirizine HCl 5 mg/5mL Solution from Cardinal Health 110, LLC. dba Leader, marketed since Feb 2017 and currently FDA-listed; retail pharmacies pay about $0.0379 per mL (NADAC). It is this product's only package size.

NDC 70000-0215-01
🏷️ FDA NDC (as labeled) 70000-0215-1 billing pads the package 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 70000-0215-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0215 product · 1 package
Package marketed since
Feb 10, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7000002151 1
Medicaid fills, this package
25,218 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0215-1
Product NDC 70000-0215
11-digit billing NDC 70000021501
NCPDP billing unit ML — per mL (volume)
RxCUI 1014673
UNII 64O047KTOA
Application # ANDA204226
SPL Set ID 6e69ba49-a487-445b-b5f3-5e468d86ac44
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 2017-02-10
Route ORAL
Dosage form SOLUTION
Substance CETIRIZINE HYDROCHLORIDE

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

GPI-14 41550020102010
GPI class All Day Allergy Childrens
GCN Seq No 021687
GCN 49290
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 CHILD ALL DAY ALLERGY 1 MG/ML
FDB brand name Children's All Day Allergy
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 021687
  • GCN: 49290
  • GPI-14 (Medi-Span): 41550020102010
  • HICL (First Databank): 006544
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1014673
Why two NDCs? The FDA registers this code as 70000-0215-1 — a 5-4-1 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 package segment → 70000-0215-01. 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.

Clinical

Label name CHILD ALL DAY ALLERGY 1 MG/ML Ingredient Cetirizine Hcl
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer package
Retail pharmacies payNADAC · weekly $0.038 $4.47 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0841 $9.92 / 118 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.038 $0.032
▲ Up 11% 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
70000-0215-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2017-02-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 1 mg/mL 00121-0874-04 PAI 120 ml $0.022 AA Availability likely save 41%
Cetirizine Hydrochloride 1 mg/mL 16571-0134-12 Rising 120 ml $0.022 AA Availability likely save 41%
Cetirizine Hydrochloride 1 mg/mL 45802-0626-26 Padagis 1 bottle $0.022 AA Availability likely save 41%
Cetirizine Hydrochloride 1 mg/mL 51672-4070-08 Sun 1 bottle $0.022 AA Availability likely save 41%
Cetirizine Hydrochloride Oral Solution 5 mg/5mL 62135-0057-41 Chartwell 120 ml $0.022 AA Availability likely save 41%
Cetirizine Hydrochloride 1 mg/mL 69452-0426-55 Bionpharma 120 ml $0.022 AA Availability likely save 41%
Cetirizine hydrochloride 1 mg/mL 72888-0480-01 Advagen 120 ml $0.022 AA Availability likely save 41%
Cetirizine Hydrochloride Oral Solution 1 mg/mL 83745-0185-04 APOZEAL 120 ml $0.022 AA Availability likely save 41%
Good Neighbor Pharmacy Childrens All Day Allergy 5 mg/5mL 46122-0203-26 Amerisource 1 bottle $0.035 — Availability likely save 7%
Cetirizine Hydrochloride 1 mg/mL 57237-0357-12 Rising 120 ml $0.035 — Availability likely save 7%
Cetirizine Hydrochloride 1 mg/mL 57237-0358-12 Rising 120 ml $0.035 — Availability likely save 7%
foster and thrive childrens allergy relief 5 mg/5mL 70677-1042-01 Strategic 1 bottle $0.035 — Availability likely save 7%
Cetirizine Hydrochloride 1 mg/mL 70677-1236-01 STRATEGIC 1 bottle $0.035 — Availability likely save 7%
Childrens Allergy Relief 1 mg/mL 70677-0149-01 Strategic 1 bottle $0.037 — FDA listed save 4%
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0189-26 L. 1 bottle $0.038 — Availability likely —
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0503-26 L. 1 bottle $0.038 — Availability likely —
childrens cetirizine hydrochloride 5 mg/5mL 00904-6765-20 Major 1 bottle $0.038 — Availability likely —
cetirizine hydrochloride 5 mg/5mL 45802-0974-26 Padagis 1 bottle $0.038 — Availability likely —
All Day Allergy 5 mg/5mL 46122-0101-26 Amerisource 1 bottle $0.038 — Availability likely —
Childrens Allergy Relief 1 mg/mL 69230-0316-11 Camber 1 bottle $0.038 — Availability likely —
Leader Childrens All Day Allergy 5 mg/5mL 70000-0214-01 Cardinal 1 bottle $0.038 — Availability likely —
Leader Childrens all day allergy 5 mg/5mLthis 70000-0215-01 Cardinal 1 bottle $0.038 — Availability likely —
Cetirizine Hydrochloride 1 mg/mL 70752-0104-06 QUAGEN 1 bottle $0.038 — Availability likely —
Cetrizine Hydrochloride 1 mg/mL 83745-0188-04 APOZEAL 1 bottle $0.038 — Availability likely —
Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL 68094-0004-62 Precision 10 cups $0.447 — Availability likely +1079%
Wal-Zyr All Day Allergy 5 mg/5mL 00363-2106-01 WALGREEN 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 00363-3311-26 Walgreen 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 00363-3393-26 Walgreen 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 11822-0475-00 Rite 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 11822-1189-00 Rite 1 bottle — — FDA listed —
Rite Aid childrens allergy relief 1 mg/mL 11822-2106-08 Rite 1 bottle — — FDA listed —
childrens cetirizine hydrochloride 5 mg/5mL 17856-6765-01 ATLANTIC 72 cups — — FDA listed —
Signature Care Childrens Allergy Relief 5 mg/5mL 21130-0189-34 Safeway 1 bottle — — Discontinued —
childrens allergy relief 5 mg/5mL 21130-0465-34 Safeway 1 bottle — — FDA listed —
Signature Care Childrens Allergy Relief 5 mg/5mL 21130-0475-26 Safeway 1 bottle — — Discontinued —
childrens allergy relief 5 mg/5mL 21130-0653-26 Safeway 1 bottle — — FDA listed —
Cetirizine hydrochloride 5 mg/5mL 23155-0929-51 Heritage 120 ml — AA FDA listed —
childrens all day allergy 5 mg/5mL 30142-0189-26 Kroger 1 bottle — — FDA listed —
Childrens All Day Allergy 5 mg/5mL 30142-0475-26 Kroger 1 bottle — — FDA listed —
childrens dye free allergy relief 5 mg/5mL 30142-0643-26 Kroger 1 bottle — — FDA listed —
childrens dye free allergy relief 5 mg/5mL 30142-0689-26 Kroger 1 bottle — — FDA listed —
Topcare Childrens All Day Allergy 5 mg/5mL 36800-0189-26 Topco 1 bottle — — FDA listed —
TopCare Childrens All Day Allergy 5 mg/5mL 36800-0475-00 Topco 1 bottle — — FDA listed —
HEB Allergy Relief 5 mg/5mL 37808-0102-08 H 1 bottle — — FDA listed —
Allergy Relief 1 mg/mL 37808-0106-08 H 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 37808-0671-26 H 1 bottle — — Discontinued —
Equaline childrens all day allergy 5 mg/5mL 41163-0475-26 United 1 bottle — — FDA listed —
Childrens 24 Hour Allergy 5 mg/5mL 41250-0189-26 Meijer 1 bottle — — FDA listed —
Childrens 24 Hour Allergy 5 mg/5mL 41250-0475-26 Meijer 1 bottle — — FDA listed —
careone childrens allergy relief 5 mg/5mL 41520-0301-26 American 1 bottle — — FDA listed —
careone childrens allergy relief 5 mg/5mL 41520-0902-26 American 1 bottle — — FDA listed —
Childrens All Day Allergy 5 mg/5mL 42507-0203-26 HyVee 1 bottle — — FDA listed —
childrens all day allergy 5 mg/5mL 42507-0475-26 HyVee 1 bottle — — FDA listed —
Childrens Allergy Relief 5 mg/5mL 49035-0106-08 Wal-Mart 1 bottle — — FDA listed —
Equate Childrens Allergy Relief 5 mg/5mL 49035-0276-01 Wal-Mart 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 50090-1103-00 A-S 1 bottle — — FDA listed —
Childrens Allergy Relief 1 mg/mL 50090-4741-00 A-S 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 50090-5220-00 A-S 1 bottle — AA FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 50090-7068-00 A-S 1 bottle — — FDA listed —
Zyrtec Hives 1 mg/mL 50580-0128-04 Kenvue 1 bottle — — FDA listed —
Childrens Zyrtec Allergy 5 mg/5mL 50580-0721-05 Kenvue 1 bottle — — FDA listed —
Childrens Zyrtec 5 mg/5mL 50580-0730-01 Kenvue 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 51672-2102-01 Sun 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 51672-2106-01 Sun 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride 1 mg/mL 51672-2147-01 Sun 1 bottle — — FDA listed —
Childrens Allergy Relief 1 mg/mL 55315-0354-31 Fred's, 1 bottle — — FDA listed —
DG Health Childrens All Day Allergy 5 mg/5mL 55910-0714-26 Dolgencorp, 1 bottle — — FDA listed —
childrens allergy 5 mg/5mL 56062-0102-08 Publix 1 bottle — — FDA listed —
Childrens Allergy 1 mg/mL 56062-0106-08 Publix 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Allergy 1 mg/mL 58602-0028-20 Aurohealth 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL 58602-0030-20 Aurohealth 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL 58602-0036-15 Aurohealth 1 bottle — — FDA listed —
Childrens Allergy Relief 1 mg/mL 58602-0422-12 Aurohealth 1 bottle — — FDA listed —
Childrens Allergy Relief 5 mg/5mL 59779-0509-26 CVS 1 bottle — — FDA listed —
allergy relief childrens 5 mg/5mL 59779-0837-26 CVS 1 bottle — — FDA listed —
Allergy Relief Childrens 5 mg/5mL 59779-0884-26 CVS 1 bottle — — Discontinued —
Cetirizine Hydrochloride 1 mg/mL 61037-0479-02 BAJAJ 120 ml — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 61037-0480-22 BAJAJ 120 ml — — FDA listed —
Childrens Allergy Relief 1 mg/mL 63868-0865-04 C.D.M.A., 1 bottle — — FDA listed —
Kirkland Signature Childrens Aller Tec 5 mg/5mL 63981-0475-43 Costco 2 bottles — — FDA listed —
Welby Childrens Allergy Relief 5 mg/5mL 64024-0475-26 Aldi 1 bottle — — FDA listed —
Cetirizine Hydrochloride 5 mg/5mL 65162-0003-86 Amneal 1 bottle — — FDA listed —
Cetirizine Hydrochloride 5 mg/5mL 65162-0005-86 Amneal 1 bottle — — FDA listed —
Cetirizine Hydrochloride 5 mg/5mL 65162-0684-86 Amneal 118 ml — AA FDA listed —
Childrens Cetirizine Hydrochloride 5 mg/5mL 68016-0023-43 Chain 1 bottle — — FDA listed —
Childrens Cetirzine 5 mg/5mL 68016-0106-08 Pharmacy 1 bottle — — FDA listed —
Premier Value Childrens Cetirizine 5 mg/5mL 68016-0165-00 Pharmacy 1 bottle — — FDA listed —
SIMPLY RIGHT childrens cetirizine 5 mg/5mL 68196-0102-01 Sam's 2 bottles — — Discontinued —
Members Mark Childrens Cetirizine 5 mg/5mL 68196-0475-43 Sam's 2 bottles — — FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 68788-4093-01 Preferred 1 bottle — — FDA listed —
childrens cetirizine hydrochloride 5 mg/5mL 68788-8188-01 Preferred 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 68788-8282-01 Preferred 1 bottle — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 68788-8523-01 Preferred 1 bottle — AA FDA listed —
Good Sense Childrens All Day Allergy 5 mg/5mL 68788-8803-01 Preferred 1 bottle — — FDA listed —
Cetirizine Hydrochloride Oral Solution 1 mg/mL 68788-8890-01 Preferred 120 ml — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 69206-0990-01 Aventura 120 ml — AA FDA listed —
Cetirizine Hydrochloride 1 mg/mL 70752-0103-06 QUAGEN 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 71205-0435-04 Proficient 1 bottle — AA FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 71205-0705-72 Proficient 1 bottle — — FDA listed —
childrens cetirizine hydrochloride 5 mg/5mL 71205-0722-04 Proficient 1 bottle — — FDA listed —
Cetirizine Hydrochloride 1 mg/mL 72162-2073-02 Bryant 1 bottle — — FDA listed —
cetirizine hydrochloride 5 mg/5mL 72162-2339-02 Bryant 1 bottle — — FDA listed —
Basic Care Childrens All Day Allergy 5 mg/5mL 72288-0330-34 Amazon.com 1 bottle — — FDA listed —
basic care childrens all day allergy 5 mg/5mL 72288-0475-34 Amazon.com 1 bottle — — FDA listed —
up and up childrens allergy 5 mg/5mL 82442-0475-26 Target 1 bottle — — FDA listed —
up and up childrens allergy 5 mg/5mL 82442-0617-26 Target 1 bottle — — FDA listed —
Childrens Cetirizine Hydrochloride Sugar Free Grape 1 mg/mL 83939-0009-01 VERITYRX, 5 ml — — FDA listed —
Childrens All Day Allergy 5 mg/5mL 72288-0818-34 Amazon.com 1 bottle — — FDA listed —
Childrens All Day Allergy 5 mg/5mL 72288-0982-34 Amazon.com 1 bottle — — 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesanhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

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

LabelerCardinal Health 110, LLC. dba Leader
Application holderPERRIGO R AND D CO
FDA applicationANDA204226 (ANDA)
Labeler code70000
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio163 products on file

More NDCs from Cardinal Health 110, LLC. dba Leader labeler code 70000

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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 164 words ▾

Directions • use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date

⚠️ Warnings 130 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.

📦 Storage and Handling 37 words ▾

Other information • store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 5 mL) Cetirizine HCl 5 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose Questions or comments? 1-800-719-9260

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 25 words ▾

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 22 words ▾

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 14 words ▾

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

📄 When Using This Product 31 words ▾

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 19 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

🤰 If Pregnant or Breast-Feeding 18 words ▾

If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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)

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 58 words ▾

Package/Label Principal Display Panel LEADER ™ Children’s All Day Allergy Cetirizine Hydrochloride Oral Solution 1mg/mL Antihistamine Indoor & Outdoor Allergies Grape Flavor Ages 2 Years and Older 24-Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Dye-Free Sugar-Free COMPARE TO CHILDREN’S ZYRTEC ® active ingredient 100% Money Back Guarantee 4 FL OZ (118mL) leader-all-day-allergy-grape-carton-image.jpg

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
25.2K
Units reimbursed last 4 qtrs
3.3M
Gross reimbursed last 4 qtrs
$278.1K
Avg / prescription
$11.03
Avg / unit
$0.0841
Latest quarter Q1 2026
6.3KRx
Medicaid pays / mL
$0.0841
gross reimbursed
vs
NADAC / mL
$0.0379
acquisition cost
=
Spread
+$0.0462
+122% vs cost
What Medicaid paid per mL (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 ⓘ
39% FFS 61% MCO
Fee-for-service · 9,900 Rx Managed care · 15,318 Rx
State Medicaid map
Alaska: no data reported AK Maine: 13,554 units · 972 per 100k residents ME Washington: 71,849 units · 920 per 100k residents WA Idaho: 1,641 units · 83.6 per 100k residents ID Montana: 4,012 units · 354 per 100k residents MT North Dakota: 14,879 units · 1,900 per 100k residents ND Minnesota: 18,078 units · 315 per 100k residents MN Wisconsin: 46,705 units · 790 per 100k residents WI Michigan: 76,172 units · 759 per 100k residents MI New York: 712,099 units · 3,639 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,948 units · 139 per 100k residents NH Oregon: 6,978 units · 165 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 15,528 units · 1,690 per 100k residents SD Iowa: 106,795 units · 3,330 per 100k residents IA Illinois: 9,292 units · 74.0 per 100k residents IL Indiana: 19,583 units · 285 per 100k residents IN Ohio: 143,900 units · 1,221 per 100k residents OH Pennsylvania: 132,727 units · 1,024 per 100k residents PA New Jersey: 80,840 units · 870 per 100k residents NJ Massachusetts: 18,274 units · 261 per 100k residents MA California: 324,759 units · 833 per 100k residents CA Utah: no data reported UT Colorado: 16,989 units · 289 per 100k residents CO Nebraska: 18,411 units · 931 per 100k residents NE Missouri: no data reported MO Kentucky: 117,133 units · 2,588 per 100k residents KY West Virginia: 40,292 units · 2,276 per 100k residents WV Virginia: 76,438 units · 877 per 100k residents VA Maryland: 86,383 units · 1,398 per 100k residents MD Connecticut: 39,553 units · 1,094 per 100k residents CT Rhode Island: 2,907 units · 265 per 100k residents RI Arizona: no data reported AZ New Mexico: 9,221 units · 436 per 100k residents NM Kansas: 24,415 units · 830 per 100k residents KS Arkansas: 34,956 units · 1,140 per 100k residents AR Tennessee: 98,064 units · 1,376 per 100k residents TN North Carolina: 36,106 units · 333 per 100k residents NC South Carolina: 38,711 units · 720 per 100k residents SC Delaware: no data reported DE Oklahoma: 80,740 units · 1,992 per 100k residents OK Louisiana: 25,562 units · 559 per 100k residents LA Mississippi: 86,246 units · 2,934 per 100k residents MS Alabama: 23,118 units · 453 per 100k residents AL Georgia: 75,976 units · 689 per 100k residents GA D.C.: 22,546 units · 3,320 per 100k residents DC Hawaii: no data reported HI Texas: 153,669 units · 504 per 100k residents TX Florida: 9,039 units · 40.0 per 100k residents FL
Units reimbursed · per 100k residents
40.03,639
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 3,639 /100k
2 Iowa 3,330 /100k
3 D.C. 3,320 /100k
4 Mississippi 2,934 /100k
5 Kentucky 2,588 /100k
6 West Virginia 2,276 /100k
7 Oklahoma 1,992 /100k
8 North Dakota 1,900 /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.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Quzyttir (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Quzyttir. CMS lists 3 products for this generic; we show the highest-spend one. 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
$402.6K
Claims incl. refills
69
Beneficiaries
17
Spend / beneficiary
$23,680.41
Spend / claim
$5,834.30
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.
← 70000-0214-01 · Cardinal 70000-0221-01 · Cardinal →
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.