HomeNDC LookupIngredientsCetirizine Hcl › 21130-0475-26
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Signature Care Childrens Allergy Relief Cetirizine HCl 5 mg/5mL Solution

by Safeway · 1 BOTTLE in 1 CARTON (21130-475-26) / 120 mL in 1 BOTTLE
NDC 21130-0475-26
🏷️ FDA NDC (as labeled) 21130-475-26 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Nov 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 21130-475-26
Product NDC 21130-475
11-digit billing NDC 21130047526
RxCUI 1014673
UNII 64O047KTOA
Application # ANDA204226
SPL Set ID b7e7d503-94dd-469a-925f-62ebc16066f7
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Nov 2024)
Marketing start 2015-09-28
Route ORAL
Dosage form SOLUTION
Substance CETIRIZINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 21130-475-26 — 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 → 21130-0475-26. 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

LabelerSafeway
Application holderPERRIGO R AND D CO
FDA applicationANDA204226 (ANDA)
Labeler code21130
First marketedSep 2015
Product typeHuman Otc Drug
Portfolio158 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

📗 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 →
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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 1 mg/mL 00121-0874-04 PAI 120 ml $0.023 AA Availability likely
Cetirizine Hydrochloride 1 mg/mL 16571-0134-12 Rising 120 ml $0.023 AA Availability likely
Cetirizine Hydrochloride 1 mg/mL 45802-0626-26 Padagis 1 bottle $0.023 AA Availability likely
Cetirizine Hydrochloride 1 mg/mL 51672-4070-08 Sun 1 bottle $0.023 AA Availability likely
Cetirizine Hydrochloride Oral Solution 5 mg/5mL 62135-0057-41 Chartwell 120 ml $0.023 AA Availability likely
Cetirizine Hydrochloride 1 mg/mL 69452-0426-55 Bionpharma 120 ml $0.023 AA Availability likely
Cetirizine hydrochloride 1 mg/mL 72888-0480-01 Advagen 120 ml $0.023 AA Availability likely
Cetirizine Hydrochloride Oral Solution 1 mg/mL 83745-0185-04 APOZEAL 120 ml $0.023 AA Availability likely
Good Neighbor Pharmacy Childrens All Day Allergy 5 mg/5mL 46122-0203-26 Amerisource 1 bottle $0.035 Availability likely
Cetirizine Hydrochloride 1 mg/mL 57237-0357-12 Rising 120 ml $0.035 Availability likely
Cetirizine Hydrochloride 1 mg/mL 57237-0358-12 Rising 120 ml $0.035 Availability likely
foster and thrive childrens allergy relief 5 mg/5mL 70677-1042-01 Strategic 1 bottle $0.035 Availability likely
Cetirizine Hydrochloride 1 mg/mL 70677-1236-01 STRATEGIC 1 bottle $0.035 Availability likely
Childrens Allergy Relief 1 mg/mL 70677-0149-01 Strategic 1 bottle $0.037 FDA listed
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0189-26 L. 1 bottle $0.037 Availability likely
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0503-26 L. 1 bottle $0.037 Availability likely
childrens cetirizine hydrochloride 5 mg/5mL 00904-6765-20 Major 1 bottle $0.037 Availability likely
cetirizine hydrochloride 5 mg/5mL 45802-0974-26 Padagis 1 bottle $0.037 Availability likely
All Day Allergy 5 mg/5mL 46122-0101-26 Amerisource 1 bottle $0.037 Availability likely
Childrens Allergy Relief 1 mg/mL 69230-0316-11 Camber 1 bottle $0.037 Availability likely
Leader Childrens All Day Allergy 5 mg/5mL 70000-0214-01 Cardinal 1 bottle $0.037 Availability likely
Leader Childrens all day allergy 5 mg/5mL 70000-0215-01 Cardinal 1 bottle $0.037 Availability likely
Cetirizine Hydrochloride 1 mg/mL 70752-0104-06 QUAGEN 1 bottle $0.037 Availability likely
Cetrizine Hydrochloride 1 mg/mL 83745-0188-04 APOZEAL 1 bottle $0.037 Availability likely
Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL 68094-0004-62 Precision 10 cups $0.447 Availability likely
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/5mLthis 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 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.

📊 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.

🔬 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 Fluticasone Propionate — the ingredient across all brands.

Top reported reactions

Dyspnoea21,832
Asthma12,800
Cough11,446
Fatigue11,026
Headache10,628
Pneumonia10,087
Nausea9,027

Reporter sex

0 reports

Serious outcomes

Death9,484
Disabling3,699
Life-threatening3,495
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14,226 6,070
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
21130-0475-26 You're viewing this 1 BOTTLE in 1 CARTON (21130-475-26) / 120 mL in 1 BOTTLE 2015-09-28 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 21130-475-26, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 21130-0475-26, written without dashes as 21130047526. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 21130-0475-26, the first segment (21130) is the labeler code FDA assigned to Safeway; the middle segment (0475) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (26) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Safeway is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 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? 1-888-723-3929

🎯 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 ↗
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.