Home › NDC Lookup › Ingredients › Loratadine › 11523-0123-01
Claritin Chewable Grape and Bubblegum Loratadine Kit, 1 kit — NDC 11523-0123-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Claritin Chewable Grape and Bubblegum Loratadine Kit, 1 kit — NDC 11523-0123-1 (Billing 11523-0123-01)

by Bayer HealthCare LLC. · 1 KIT in 1 CARTON

This is a package of 1 kit of Claritin Chewable Grape and Bubblegum Loratadine Kit from Bayer HealthCare LLC., marketed since Aug 2006 and currently FDA-listed. It is this product's only package size.

NDC 11523-0123-01
🏷️ FDA NDC (as labeled) 11523-0123-1 billing pads the package segment with a zero
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11523-0123-1
Product NDC 11523-0123
11-digit billing NDC 11523012301
RxCUI 665078, 668469
UPC 0000000000000
Application # NDA021891
SPL Set ID 0371368b-dca6-af2f-e063-6394a90a0ac0
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-08-23
Route ORAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 665078
Why two NDCs? The FDA registers this code as 11523-0123-1 — 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 → 11523-0123-01. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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

📖 What it is MedlinePlus · NLM

Loratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Loratadine 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.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves symptoms of hay fever and other upper respiratory allergies. That means runny nose, sneezing, itchy, watery eyes, and an itchy nose or throat.
  • It is taken by mouth, generally once a day. Follow the directions on your specific product. Chewable tablets should be chewed or crushed completely, and liquids should be measured...
  • No. Do not take more than directed. Taking more than directed may cause drowsiness. If you think you took too much, get medical help or call Poison Control right away.
  • Can I take extra if my allergies are bad?
📖 Read our full Loratadine 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 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.
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
11523-0123-01 You're viewing this Main listing 1 KIT in 1 CARTON 2023-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loratadine 5 mg 51660-0753-31 Ohm 10 tablets $0.404 — FDA listed —
Childrens Loratadine 5 mg 51660-0754-31 Ohm 10 tablets $0.511 — FDA listed —
Dye-Free Childrens Loratadine 5 mg 51660-0112-31 Ohm 10 tablets $0.521 — Availability likely —
foster and thrive childrens allergy relief 5 mg 70677-1043-01 Strategic 1 tablet $0.521 — Availability likely —
good sense childrens allergy relief 5 mg 00113-1019-39 L. 1 tablet — — Discontinued —
Loratadine 5 mg 00363-0752-30 WALGREEN 10 tablets — — FDA listed —
Wal-itin 5 mg 00363-0754-30 Walgreens 10 tablets — — FDA listed —
Loratadine 5 mg 00363-9985-30 WALGREENS 10 tablets — — FDA listed —
Wal-itin 5 mg 00363-9995-30 WALGREENS 10 tablets — — FDA listed —
Claritin 5 mg 11523-0104-01 Bayer 10 tablets — — FDA listed —
Claritin Chewable Grape and Bubblegumthis 11523-0123-01 Bayer 1 kit — — FDA listed —
Claritin 5 mg 11523-4328-01 Bayer 10 tablets — — FDA listed —
Claritin 5 mg 11523-4330-01 Bayer 10 tablets — — FDA listed —
Claritin 5 mg 11523-4331-01 Bayer 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11673-0111-30 UP 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11673-0115-30 UP 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 11673-0310-30 TARGET 10 tablets — — FDA listed —
Childrens Allergy 5 mg 11673-0996-30 TARGET 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 11673-0997-30 TARGET 10 tablets — — FDA listed —
childrens allergy relief 5 mg 11822-0801-01 Rite 1 tablet — — FDA listed —
Loratadine 5 mg 11822-7240-00 Rite 30 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11822-8329-07 RITE 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11822-9999-03 RITE 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 21130-0646-20 SAFEWAY 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 21130-0963-20 SAFEWAY 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 21130-0999-20 SAFEWAY 10 tablets — — FDA listed —
Loratadine 5 mg 30142-0565-30 KROGER 10 tablets — — FDA listed —
Loratadine 5 mg 30142-0984-30 KROGER 10 tablets — — FDA listed —
Loratadine 5 mg 30142-0996-30 KROGER 10 tablets — — FDA listed —
topcare childrens allergy relief 5 mg 36800-0363-39 Topco 1 tablet — — FDA listed —
Childrens Allergy Relief 5 mg 37808-0506-39 H 1 tablet — — FDA listed —
Equaline Childrens Allergy Relief 5 mg 41163-0364-01 United 1 tablet — — FDA listed —
childrens allergy relief 5 mg 41250-0629-39 Meijer 1 tablet — — FDA listed —
careone childrens allergy relief 5 mg 41520-0716-01 American 1 tablet — — FDA listed —
Childrens Loratadine 5 mg 46122-0550-60 Amerisource 10 tablets — — Discontinued —
Loratadine 5 mg 49035-0953-30 Wal-Mart 10 tablets — — FDA listed —
childrens allergy relief 5 mg 51316-0133-52 CVS 1 tablet — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 51316-0821-20 CVS 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 51660-0726-30 Ohm 10 tablets — — FDA listed —
dg health childrens allergy relief 5 mg 55910-0807-52 Dolgencorp, 1 tablet — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 56062-0900-20 PUBLIX 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 56062-0921-20 PUBLIX 10 tablets — — FDA listed —
Loratadine 5 mg 56062-0990-20 PUBLIX 10 tablets — — FDA listed —
Loratadine 5 mg 68016-0053-10 Premier 10 tablets — — FDA listed —
Berkley and Jensen Childrens Allergy Relief 5 mg 68391-0301-49 BJWC 1 tablet — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 69842-0894-30 CVS 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 69842-0895-20 CVS 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 69842-0953-20 CVS 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 69842-0954-30 CVS 10 tablets — — FDA listed —
Basic Care Childrens Allergy Relief 5 mg 72288-0901-01 Amazon.com 1 tablet — — FDA listed —
Curist Childrens Allergy Relief 5 mg 72559-0031-43 Little 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 79903-0008-30 WAL-MART 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 79903-0330-30 WAL-MART 10 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2006
On the market since
Aug 2006
📍
2026
Currently FDA-listed
20 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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

Color purple / pink
ShapeRound
ImprintC
Size1 mm
ScoringNot scored
FlavorBubble Gum
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.

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.

Manufacturer & labeler

LabelerBayer HealthCare LLC.
Application holderBAYER HEALTHCARE LLC
FDA applicationNDA021891 (NDA)
Labeler code11523
First marketedAug 2006
Product typeHuman Otc Drug
Portfolio240 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 words ▾

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

⏱️ Dosage and Administration 67 words ▾

Directions chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings 110 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs.

Seek medical help right away. If pregnant or breast-feeding , 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.

📦 Storage and Handling 47 words ▾

Other Information phenylketonurics: grape flavor contains phenylalanine 1.4 mg per chewable tablet bubblegum flavor contains phenylalanine 1.9 mg per chewable tablet safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn store between 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Loratadine 5 mg

🧪 Inactive Ingredients 56 words ▾

Inactive ingredients Grape chewable tablets aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic aicd Bubblegum chewable tablets aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

🎯 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 ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 ✓ Available
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.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bayer HealthCare LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer HealthCare LLC. 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.
← 11523-0122-01 · Bayer 11523-0124-01 · Bayer →
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.