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Cetirizine Hydrochloride 10 mg Tablet, Chewable, 100-count — NDC 47335-344-88 (Billing 47335-0344-88)

by Sun Pharmaceutical Industries, Inc. · 100 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 100 tablets of Cetirizine Hydrochloride 10 mg Tablet, Chewable from Sun Pharmaceutical Industries, Inc., no longer marketed (first marketed Sep 2011), no longer in the FDA NDC Directory.

NDC 47335-0344-88
🏷️ FDA NDC (as labeled) 47335-344-88 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Product page 47335-0344-83 Also comes in: 30 tablets 47335-344-83 30 tablets 47335-344-15 100 tablets 47335-344-16
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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 47335-344-88 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
47335 labeler · 344 product · 88 package
Package marketed since
Sep 9, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0347335344837, 0347335343830
FDA record last changed
Jul 14, 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 ↗
⚠️
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 Dec 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47335-344-88
Product NDC 47335-344
11-digit billing NDC 47335034488
RxCUI 1014643, 1014674
UNII 64O047KTOA
UPC 0347335344837, 0347335343830
Application # ANDA090142
SPL Set ID a4758152-97dd-4a27-b4d9-11178654b93e
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 Dec 2024)
Marketing start 2011-09-09
Route ORAL
Dosage form TABLET, CHEWABLE
Substance CETIRIZINE HYDROCHLORIDE

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

GPI-14 41550020100520
GPI class Cetirizine HCl
GCN Seq No 053981
GCN 21771
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 10 MG CHEW TB
FDB brand name Children's Cetirizine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 053981
  • GCN: 21771
  • GPI-14 (Medi-Span): 41550020100520
  • HICL (First Databank): 006544
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 1014643
Why two NDCs? The FDA registers this code as 47335-344-88 — 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 → 47335-0344-88. 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 10 MG CHEW TB 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

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.

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 eachPer 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.
Try another pack size: 30 tablets 30 tablets 100 tablets
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 Per unit Per pack Marketing startMarketing endStatus
47335-0344-83 47335-344-83 Main listing 30 TABLET, CHEWABLE in 1 BOTTLE $2.22 / ea $66.56 2011-09-09 — Discontinued by firm
47335-0344-88 You're viewing this 100 TABLET, CHEWABLE in 1 BOTTLE — — 2011-09-09 — Discontinued by firm
47335-0344-15 47335-344-15 30 TABLET, CHEWABLE in 1 BOTTLE — — 2011-09-26 — Discontinued by firm
47335-0344-16 47335-344-16 100 TABLET, CHEWABLE in 1 BOTTLE — — 2011-09-26 — Discontinued by firm

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, chewable in 1 bottle.
How does this package differ from NDC 47335-0344-83?
Both are Cetirizine Hydrochloride 10 mg Tablet, Chewable — the drug itself is identical. This page's package is the 100-count one, while NDC 47335-0344-83 is the 30 tablets package.
What NDC number is used to bill for this package of Cetirizine Hydrochloride 10 mg Tablet, Chewable?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine Hydrochloride 10 mg 00781-5284-64 Sandoz 1 tablet $2.114 — Availability likely —
Cetirizine Hydrochloride 10 mgthis 47335-0344-88 Sun 100 tablets — — Discontinued —
Childrens Zyrtec 10 mg 50090-6781-00 A-S 6 tablets — — FDA listed —
Zyrtec 10 mg 50580-0753-24 Kenvue 6 tablets — — FDA listed —
Childrens Zyrtec 10 mg 50580-0791-01 Kenvue 6 tablets — — FDA listed —
Cetirizine Hydrochloride 10 mg 51660-0066-30 OHM 30 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA090142 (ANDA)
Labeler code47335
First marketedSep 2011
Product typeHuman Otc Drug
Portfolio890 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 47335

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 161 words ▾

Directions may be taken with or without water chew or crush tablets completely before swallowing For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) in 24 hours.

A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings 1 words ▾

Warnings

📦 Storage and Handling 30 words ▾

Other information store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn see top layer for lot number and expiration date

🧪 Active Ingredient 22 words ▾

Active ingredient (in each chewable tablet) For 5 mg: Cetirizine hydrochloride, USP 5 mg For 10 mg: Cetirizine hydrochloride, USP 10 mg

🧪 Inactive Ingredients 51 words ▾

Inactive ingredients acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

🎯 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 44 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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

📄 Stop Use and Ask a Doctor If 18 words ▾

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

🤰 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)

📄 Package Label / Principal Display Panel 88 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 5 mg Allergy: Original Prescription Strength NDC 47335-343-83 Cetirizine Hydrochloride Chewable Tablets 5 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. spl-cetirizine-5mg-allergy-1 spl-cetirizine-5mg-allergy-2 spl-cetirizine-5mg-allergy-3 spl-cetirizine-5mg-allergy-4 spl-cetirizine-5mg-allergy-5 spl-cetirizine-5mg-allergy-6 spl-cetirizine-5mg-allergy-7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 10 mg Allergy: Original Prescription Strength NDC 47335-344-83 Cetirizine Hydrochloride Chewable Tablets 10 mg ALLERGY Antihistamine Indoor & Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMA spl-cetirizine-10mg-allergy-1 spl-cetirizine-10mg-allergy-22 spl-cetirizine-10mg-allergy-33

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets47335-0344-83 421 Rx · $19,933
100 tablets this page47335-0344-88 No Medicaid data
30 tablets47335-0344-15 No Medicaid data
100 tablets47335-0344-16 No Medicaid data
Drug total (last 4 qtrs): 421 Rx · 12,774 units · $19,933 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (47335-0344-83), 30 tablets (47335-0344-15), 100 tablets (47335-0344-16). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. 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.
← 47335-0343-83 · Sun 47335-0361-41 · Sun →
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.