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CHILDRENS ALLERGY RELIEF cetirizine hydrochloride 1 mg/mL Solution — NDC 70677-0149-01 package photo

CHILDRENS ALLERGY RELIEF cetirizine hydrochloride 1 mg/mL Solution

by Strategic Sourcing Services · 1 BOTTLE in 1 CARTON (70677-0149-1) / 118 mL in 1 BOTTLE
NDC 70677-0149-01
🏷️ FDA NDC (as labeled) 70677-0149-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Cetirizine Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jun 24, 2026 — Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0732-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0032-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0033-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70677-0149-1
Product NDC 70677-0149
11-digit billing NDC 70677014901
NCPDP billing unit ML — per mL (volume)
RxCUI 1014673
UNII 64O047KTOA
Application # ANDA210622
SPL Set ID 1dd63ede-37ca-4b5a-bfed-1aca5dd15424
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 2022-07-21
Route ORAL
Dosage form SOLUTION
Substance CETIRIZINE HYDROCHLORIDE
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 SM CHILD ALL DAY ALLER 1 MG/ML
FDB brand name Children's All Day Allergy
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-0149-1 — 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 → 70677-0149-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives, Other antiallergics
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerStrategic Sourcing Services
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA210622 (ANDA)
Labeler code70677
First marketedJul 2022
Product typeHuman Otc Drug
Portfolio23 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SM CHILD ALL DAY ALLER 1 MG/ML Ingredient Cetirizine Hcl
📖 What it is MedlinePlus · NLM

Cetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Cetirizine is also used to treat urticaria (hives; itchy raised red bumps on skin). Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine. This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Cetirizine is an antihistamine that helps with allergies and hives. Most oral products — tablets, capsules, solutions — treat classic allergy symptoms like runny nose, sneezing, it...
  • It can, yes — drowsiness is the most commonly reported side effect. Cetirizine is considered less sedating than older antihistamines because it doesn't penetrate the brain as readi...
  • You can take oral cetirizine with or without food — it doesn't matter much. Food doesn't reduce the total amount absorbed, though it can delay the peak effect by an hour or two. So...
  • Can I take cetirizine with food, or does it need to be on an empty stomach?
📖 Read our full Cetirizine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:

BeerModerate WineModerate Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Cetirizine Hydrochloride (5 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow
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.

💡 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 statesanhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and 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.

💲 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 $0.037 $4.32 / 118 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2024 Feb 2024 $0.037 $0.033
▲ Up 12% over the last 3 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 1 mg/mL 00121-0874-04 PAI 120 ml $0.023 AA Availability likely save 38%
Cetirizine Hydrochloride 1 mg/mL 16571-0134-12 Rising 120 ml $0.023 AA Availability likely save 38%
Cetirizine Hydrochloride 1 mg/mL 45802-0626-26 Padagis 1 bottle $0.023 AA Availability likely save 38%
Cetirizine Hydrochloride 1 mg/mL 51672-4070-08 Sun 1 bottle $0.023 AA Availability likely save 38%
Cetirizine Hydrochloride Oral Solution 5 mg/5mL 62135-0057-41 Chartwell 120 ml $0.023 AA Availability likely save 38%
Cetirizine Hydrochloride 1 mg/mL 69452-0426-55 Bionpharma 120 ml $0.023 AA Availability likely save 38%
Cetirizine hydrochloride 1 mg/mL 72888-0480-01 Advagen 120 ml $0.023 AA Availability likely save 38%
Cetirizine Hydrochloride Oral Solution 1 mg/mL 83745-0185-04 APOZEAL 120 ml $0.023 AA Availability likely save 38%
Good Neighbor Pharmacy Childrens All Day Allergy 5 mg/5mL 46122-0203-26 Amerisource 1 bottle $0.035 — Availability likely save 4%
Cetirizine Hydrochloride 1 mg/mL 57237-0357-12 Rising 120 ml $0.035 — Availability likely save 4%
Cetirizine Hydrochloride 1 mg/mL 57237-0358-12 Rising 120 ml $0.035 — Availability likely save 4%
foster and thrive childrens allergy relief 5 mg/5mL 70677-1042-01 Strategic 1 bottle $0.035 — Availability likely save 4%
Cetirizine Hydrochloride 1 mg/mL 70677-1236-01 STRATEGIC 1 bottle $0.035 — Availability likely save 4%
Childrens Allergy Relief 1 mg/mLthis 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 +2%
Good Sense Childrens All Day Allergy 5 mg/5mL 00113-0503-26 L. 1 bottle $0.037 — Availability likely +2%
childrens cetirizine hydrochloride 5 mg/5mL 00904-6765-20 Major 1 bottle $0.037 — Availability likely +2%
cetirizine hydrochloride 5 mg/5mL 45802-0974-26 Padagis 1 bottle $0.037 — Availability likely +2%
All Day Allergy 5 mg/5mL 46122-0101-26 Amerisource 1 bottle $0.037 — Availability likely +2%
Childrens Allergy Relief 1 mg/mL 69230-0316-11 Camber 1 bottle $0.037 — Availability likely +2%
Leader Childrens All Day Allergy 5 mg/5mL 70000-0214-01 Cardinal 1 bottle $0.037 — Availability likely +2%
Leader Childrens all day allergy 5 mg/5mL 70000-0215-01 Cardinal 1 bottle $0.037 — Availability likely +2%
Cetirizine Hydrochloride 1 mg/mL 70752-0104-06 QUAGEN 1 bottle $0.037 — Availability likely +2%
Cetrizine Hydrochloride 1 mg/mL 83745-0188-04 APOZEAL 1 bottle $0.037 — Availability likely +2%
Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL 68094-0004-62 Precision 10 cups $0.447 — Availability likely +1122%
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
Jul 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.

🔬 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 childrens allergy relief (this brand).

Top reported reactions

Fatigue17,304
Pain15,124
Headache12,162
Nausea11,084
Rash10,729
Dyspnoea10,699
Arthralgia9,985

Age at onset

Neonate127
Infant97
Child1,130
Adolescent961
Adult17,557
Elderly8,425

Reporter sex

141,163 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization41,358
Death15,209
Life-threatening9,040
Disabling8,742
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,355 0
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
70677-0149-01 You're viewing this 1 BOTTLE in 1 CARTON (70677-0149-1) / 118 mL in 1 BOTTLE 2022-07-21 Active

📄 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
🎯 Indications and Usage 26 words ▾

USE(S) 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 1 words ▾

WARNINGS

📦 Storage and Handling 36 words ▾

Other Information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or bottle wrap imprinted “SAFETY SEAL®” is broken or missing see top panel for lot number and expiration date

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENT(S) (in each 5 mL) Cetirizine Hydrochloride USP 5mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

🎯 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 ↗
← 70677-0148-01 · Strategic 70677-0150-01 · Strategic →
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.