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topcare childrens allergy relief loratadine 5 mg Tablet, Chewable — NDC 36800-0363-39 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

topcare childrens allergy relief loratadine 5 mg Tablet, Chewable — NDC 36800-363-39 (Billing 36800-0363-39)

by Topco Associates LLC · 30 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK

This is a package of topcare childrens allergy relief loratadine 5 mg Tablet, Chewable from Topco Associates LLC, marketed since Sep 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 36800-0363-39
🏷️ FDA NDC (as labeled) 36800-363-39 billing pads the product segment with a zero
This package
Contains1 tablet, chewable in 1 blister pack Pack sizes2 compare ↓
Main listing for product 36800-363 · Also comes in: 1 tablet 36800-363-49
OTC Generic 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

NDC database record

One package, one record: these facts belong to NDC 36800-363-39 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
36800 labeler · 363 product · 39 package
Package marketed since
Sep 20, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3680036339 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-363-39
Product NDC 36800-363
11-digit billing NDC 36800036339
RxCUI 665078
UNII 7AJO3BO7QN
Application # ANDA210033
SPL Set ID 4f7555ea-6286-4ff6-b125-d12660ae4bdf
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-20
Route ORAL
Dosage form TABLET, CHEWABLE
Substance LORATADINE

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

GPI-14 81200000000900
GPI class Balanced Nutritional Shake Pls
Quick answers
  • GPI-14 (Medi-Span): 81200000000900
  • RxCUI (RxNorm): 665078
Why two NDCs? The FDA registers this code as 36800-363-39 — 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 → 36800-0363-39. 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.
Try another pack size: 1 tablet
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
36800-0363-39 You're viewing this Main listing 30 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK 2019-09-20 — Active
36800-0363-49 36800-363-49 40 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK 2023-06-20 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 30 blister pack in 1 carton / 1 tablet, chewable in 1 blister pack.
What NDC number is used to bill for this package of topcare childrens allergy relief loratadine 5 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.

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 mgthis 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 —
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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

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

LabelerTopco Associates LLC
Application holderPERRIGO PHARMA INTERNATIONAL DESIGNATED ACTIVITY CO
FDA applicationANDA210033 (ANDA)
Labeler code36800
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 36800

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 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 66 words ▾

Directions • chew or crush tablets completely before swallowing 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 36 words ▾

Other information • phenylketonurics: contains phenylalanine 1.4 mg per tablet • do not use if blister unit is broken 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 29 words ▾

Inactive ingredients artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 19 words ▾

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 22 words ▾

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 17 words ▾

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

📄 Stop Use and Ask a Doctor If 19 words ▾

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

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, 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).

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 69 words ▾

Principal Display Panel TopCare ® health COMPARE TO CHILDREN’S CLARITIN ® ACTIVE INGREDIENT children’s NON-DROWSY* Allergy Relief LORATADINE CHEWABLE TABLETS, 5 mg • ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 2 Years & older GRAPE FLAVOR 30 CHEWABLE TABLETS *When taken as directed. See Drug Facts Panel. actual size childrens allergy relief image

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
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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tablet (36800-0363-49). 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?
Topco Associates 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.
← 36800-0362-10 · Topco 36800-0364-10 · Topco →
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.