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Childrens Loratadine 5 mg Tablet, Chewable

by Amerisource Bergen · 2 BLISTER PACK in 1 CARTON (46122-550-60) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
NDC 46122-0550-60
🏷️ FDA NDC (as labeled) 46122-550-60 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
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 May 2020. 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) 46122-550-60
Product NDC 46122-550
11-digit billing NDC 46122055060
NCPDP billing unit EA — each (per item)
RxCUI 665078
UNII 7AJO3BO7QN
Application # ANDA210088
SPL Set ID 8ec562d3-9d4c-4e28-bc8e-f725079f603a
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2020)
Marketing start 2018-07-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance LORATADINE
GPI-14 41550030000520
GPI class GNP Loratadine Childrens
GCN Seq No 062340
GCN 98118
HICL code 007605
Ingredient (HICL) Loratadine
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 LORATADINE 5 MG TAB CHEW
FDB brand name Children's Loratadine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-550-60 — 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 → 46122-0550-60. 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.

🏭 Manufacturer & labeler

LabelerAmerisource Bergen
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA210088 (ANDA)
Labeler code46122
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio206 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 CHILD LORATADINE 5 MG TAB CHEW Ingredient Loratadine
📗 Our plain-language guide HelloPharmacist
  • Loratadine is an antihistamine that temporarily relieves common allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy nose or throat. It works f...
  • When taken as directed, loratadine is considered non-drowsy for most people. However, if you take more than the recommended daily amount, drowsiness can happen. So stick to the dos...
  • It depends on the age. Children 6 and older can take standard adult doses of most forms. Children 2 to under 6 can use the oral solution or chewable tablets, but at a lower amount....
  • You should check with your doctor before taking loratadine if you have liver or kidney disease. Your doctor may need to adjust your dose. It's not necessarily off-limits, but it's...
📖 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.

🧪 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 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.

🔁 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 Bubblegum 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 mgthis 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 —
Loratadine 5 mg 00363-9994-30 WALGREENS 10 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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 LORATADINE (this brand).

Top reported reactions

Fatigue3,296
Nausea2,748
Dyspnoea2,491
Headache2,460
Diarrhoea2,428
Dizziness2,114
Pain2,018

Reporter sex

0 reports

Serious outcomes

Hospitalization13,912
Death2,893
Life-threatening1,619
Disabling1,268
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,225 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
46122-0550-60 You're viewing this 2 BLISTER PACK in 1 CARTON (46122-550-60) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2018-07-01 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 46122-550-60, 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: 46122-0550-60, written without dashes as 46122055060. 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 46122-0550-60, the first segment (46122) is the labeler code FDA assigned to Amerisource Bergen; the middle segment (0550) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Amerisource Bergen 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 ⏱️ 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 sneezing itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 58 words ▾

Directions adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 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 (1-800-222-1222).

📦 Storage and Handling 34 words ▾

Other information phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Loratadine USP, 5 mg

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients 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 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 ↗
← 46122-0548-90 · Amerisource 46122-0555-28 · AmerisourceBergen →
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.