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CETIRIZINE HYDROCHLORIDE 1 mg/mL Solution — NDC 70752-104-06 (Billing 70752-0104-06)

by QUAGEN PHARMACEUTICALS LLC · 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC

This is a package of CETIRIZINE HYDROCHLORIDE 1 mg/mL Solution from QUAGEN PHARMACEUTICALS LLC, marketed since Oct 2022 and currently FDA-listed; retail pharmacies pay about $0.0379 per mL (NADAC). It is this product's only package size.

NDC 70752-0104-06
🏷️ FDA NDC (as labeled) 70752-104-06 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 70752-104-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70752 labeler · 104 product · 06 package
Package marketed since
Oct 15, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0370752104067
Medicaid fills, this package
384,052 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70752-104-06
Product NDC 70752-104
11-digit billing NDC 70752010406
NCPDP billing unit ML — per mL (volume)
RxCUI 1014673
UNII 64O047KTOA
UPC 0370752104067
Application # ANDA212266
SPL Set ID 9163cd2e-0be7-4009-b905-729014773d6e
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 2022-10-15
Route ORAL
Dosage form SOLUTION
Substance CETIRIZINE HYDROCHLORIDE

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

GPI-14 41550020102010
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 CETIRIZINE HCL 1 MG/ML
FDB brand name Children's Cetirizine Hcl
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 70752-104-06 — 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 → 70752-0104-06. 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 CETIRIZINE HCL 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 →
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 $0.0688 $8.12 / 118 ml
Medicare drug plans payPart D · Q2 2026 $0.0685 $8.08 / 118 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.038 $0.033
▲ Up 16% over the last 13 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
70752-0104-06 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC 2022-10-15 — 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/5mL 70000-0215-01 Cardinal 1 bottle $0.038 — Availability likely —
Cetirizine Hydrochloride 1 mg/mLthis 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 —
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

🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 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

FlavorGrape
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 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 statesBubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose Grape Syrup:  anhydrous 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

LabelerQUAGEN PHARMACEUTICALS LLC
Application holderQUAGEN PHARMACEUTICALS LLC
FDA applicationANDA212266 (ANDA)
Labeler code70752
First marketedOct 2022
Product typeHuman Otc Drug
Portfolio52 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 124 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

⚠️ Warnings 158 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.

Side effects occur: You may report side effects to FDA at 1-800-FDA-1088. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children.

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

📦 Storage and Handling 45 words ▾

Other Information store between 20° to 25°C (68° to 77°F) Protect from light do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" 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 38 words ▾

Inactive ingredients Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

🎯 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 27 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 31 words ▾

Stop use and ask a doctor if: an allergic reaction to this product occurs. Seek medical help right away. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.

🤰 If Pregnant or Breast-Feeding 16 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? Call 1-888-344-9603 (toll-free)

📄 Package Label / Principal Display Panel 39 words ▾

PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Label

PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container Label

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
384.1K
Units reimbursed last 4 qtrs
59.6M
Gross reimbursed last 4 qtrs
$4.1M
Avg / prescription
$10.67
Avg / unit
$0.0688
Latest quarter Q1 2026
52.5KRx
Medicaid pays / mL
$0.0688
gross reimbursed
vs
NADAC / mL
$0.0379
acquisition cost
=
Spread
+$0.0309
+82% 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 ⓘ
24% FFS 76% MCO
Fee-for-service · 93,167 Rx Managed care · 290,885 Rx
State Medicaid map
Alaska: 44,156 units · 6,024 per 100k residents AK Maine: 209,818 units · 15,041 per 100k residents ME Washington: 447,737 units · 5,731 per 100k residents WA Idaho: 56,097 units · 2,856 per 100k residents ID Montana: 58,242 units · 5,145 per 100k residents MT North Dakota: 22,568 units · 2,882 per 100k residents ND Minnesota: 393,944 units · 6,867 per 100k residents MN Wisconsin: 478,598 units · 8,098 per 100k residents WI Michigan: 2,651,192 units · 26,414 per 100k residents MI New York: 4,320,408 units · 22,076 per 100k residents NY Vermont: 85,949 units · 13,284 per 100k residents VT New Hampshire: 68,658 units · 4,897 per 100k residents NH Oregon: 261,671 units · 6,182 per 100k residents OR Nevada: 206,427 units · 6,463 per 100k residents NV Wyoming: 13,169 units · 2,255 per 100k residents WY South Dakota: 142,338 units · 15,488 per 100k residents SD Iowa: 1,026,377 units · 32,004 per 100k residents IA Illinois: 368,043 units · 2,933 per 100k residents IL Indiana: 1,829,283 units · 26,658 per 100k residents IN Ohio: 5,253,820 units · 44,581 per 100k residents OH Pennsylvania: 4,673,411 units · 36,057 per 100k residents PA New Jersey: 1,457,747 units · 15,692 per 100k residents NJ Massachusetts: 4,180,015 units · 59,706 per 100k residents MA California: no data reported CA Utah: 176,012 units · 5,151 per 100k residents UT Colorado: 443,470 units · 7,545 per 100k residents CO Nebraska: 415,937 units · 21,028 per 100k residents NE Missouri: no data reported MO Kentucky: 2,303,427 units · 50,893 per 100k residents KY West Virginia: 666,925 units · 37,679 per 100k residents WV Virginia: 2,669,293 units · 30,625 per 100k residents VA Maryland: 1,922,356 units · 31,106 per 100k residents MD Connecticut: 1,440,862 units · 39,836 per 100k residents CT Rhode Island: 843,930 units · 77,071 per 100k residents RI Arizona: 583,566 units · 7,853 per 100k residents AZ New Mexico: 63,989 units · 3,027 per 100k residents NM Kansas: 442,187 units · 15,040 per 100k residents KS Arkansas: 819,035 units · 26,705 per 100k residents AR Tennessee: 1,664,872 units · 23,363 per 100k residents TN North Carolina: 5,996,717 units · 55,346 per 100k residents NC South Carolina: 2,198,314 units · 40,914 per 100k residents SC Delaware: 192,768 units · 18,697 per 100k residents DE Oklahoma: 897,224 units · 22,137 per 100k residents OK Louisiana: 338,120 units · 7,392 per 100k residents LA Mississippi: 716,218 units · 24,361 per 100k residents MS Alabama: 922,256 units · 18,055 per 100k residents AL Georgia: 4,928,974 units · 44,691 per 100k residents GA D.C.: 464,163 units · 68,360 per 100k residents DC Hawaii: no data reported HI Texas: 130,854 units · 429 per 100k residents TX Florida: 97,179 units · 430 per 100k residents FL
Units reimbursed · per 100k residents
42977,071
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 Rhode Island 77,071 /100k
2 D.C. 68,360 /100k
3 Massachusetts 59,706 /100k
4 North Carolina 55,346 /100k
5 Kentucky 50,893 /100k
6 Georgia 44,691 /100k
7 Ohio 44,581 /100k
8 South Carolina 40,914 /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.