Is Loratadine a prescription drug?

No. Loratadine is sold over the counter (OTC) without a prescription.

Are there other products with the same active ingredient as Loratadine?

Yes. Other FDA-listed products with the same active ingredients include allergy relief, Loratadine ODT, Dye-Free Childrens Loratadine, childrens allergy relief.

Who makes Loratadine?

51 manufacturers list Loratadine with the FDA, including Rite Aid Corporation, AMZ789 LLC, Advagen Pharma Limited.

Checked Oct 26, 2026

OTC

Loratadine

Loratadine is an over-the-counter drug, made by 51 manufacturers.

Type: Over the counter
Drug class: Not classified
Route: Oral
Manufacturers: 51; + 26 repackager labels

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

Drug facts

Name: Loratadine
Active ingredients: Loratadine
Dosage forms: Capsule, liquid filled, Solution, Tablet, Tablet, chewable, Tablet, orally disintegrating
Label holder: Rite Aid Corporation
FDA application: ANDA076011
Label updated: 09/04/2026

Active ingredients

(in each tablet) Loratadine 10 mg

Purpose

Antihistamine

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

Directions

Place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

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).

Do not use

If you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use

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

An allergic reaction to this product occurs. Seek medical help right away.

Pregnancy or breastfeeding

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).

Inactive ingredients

Croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions?

1-800-719-9260

Forms and strengths

From the FDA NDC Directory · 98 product codes

Dosage form	Strength	Route	NDCs
Capsule, liquid filled	10 mg	oral	8
Solution	5 mg/5mL	oral	9
Tablet	5 mg	oral	5
Tablet	10 mg	oral	57
Tablet, chewable	5 mg	oral	10
Tablet, orally disintegrating	5 mg	oral	1
Tablet, orally disintegrating	10 mg	oral	8

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

NADAC lists 27 package codes for this drug, priced in different units.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 106,992 reports that list loratadine, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

Drug ineffective12,992
Fatigue6,654
Nausea5,872
Headache5,355
Diarrhea4,848
Dyspnea4,831
Off label use4,620
Dizziness4,358
Pain4,106
Rash3,469

To report a side effect, use FDA MedWatch.

Manufacturers and labels

97 FDA labels · 26 from repackagers

Rite Aid CorporationShown hereANDA076011 · Label 09/04/2026 · NDC 11822-0558Full label
AMZ789 LLCANDA210722 · Label 01/08/2025 · NDC 73629-003Full label
Advagen Pharma LimitedANDA214280 · Label 01/05/2026 · NDC 72888-029Full label
Advanced Rx LLCANDA210722 · Label 02/25/2025 · NDC 80513-711Full label
Aurobindo Pharma LimitedANDA208314 · Label 11/12/2025 · NDC 84386-119Full label
Aurohealth LLCANDA211900 · Label 10/23/2024 · NDC 58602-818Full label
Aurohealth LLCANDA208314 · Label 11/03/2022 · NDC 58602-831Full label
Aurohealth LLCANDA208314 · Label 06/18/2022 · NDC 58602-847Full label
Aurohealth LLCANDA208314 · Label 08/13/2020 · NDC 58602-702Full label
Bionpharma Inc.ANDA202538 · Label 12/23/2024 · NDC 69452-283Full label
Bionpharma Inc.ANDA202538 · Label 01/08/2019 · NDC 69452-211Full label
BluePoint LaboratoriesANDA208314 · Label 06/20/2022 · NDC 68001-438Full label
CVS HEALTH CORPANDA206214 · Label 03/26/2026 · NDC 69842-686Full label
CVS PHARMACY, INCANDA212795 · Label 12/31/2024 · NDC 51316-502Full label
CVS PHARMACY, INCANDA213294 · Label 01/02/2024 · NDC 51316-503Full label
CVS PharmacyANDA076134 · Label 12/21/2021 · NDC 59779-528Full label
CVS Pharmacy, Inc.ANDA208314 · Label 03/20/2026 · NDC 69842-242Full label
Cabinet Health P.B.C.ANDA214684 · Label 10/27/2025 · NDC 82725-0142Full label
Camber Consumer Care IncANDA210409 · Label 04/10/2026 · NDC 69230-322Full label
Camber Consumer Care IncANDA211718 · Label 09/08/2023 · NDC 69230-323Full label
Camber Consumer Care IncANDA210722 · Label 12/06/2022 · NDC 69230-328Full label
Cardinal HealthANDA208314 · Label 06/14/2024 · NDC 70000-0583Full label
Cardinal Health, 110 dba LEADERANDA076805 · Label 06/23/2021 · NDC 70000-0125Full label
Chain Drug Consortium, LLCANDA208314 · Label 11/04/2022 · NDC 68016-094Full label
Chain Drug Marketing Association Inc.ANDA076134 · Label 08/27/2018 · NDC 63868-151Full label
Dr. Reddy's Laboratories Inc.ANDA213294 · Label 06/25/2023 · NDC 43598-758Full label
Dr. Reddy's Laboratories Inc.ANDA213294 · Label 06/25/2023 · NDC 43598-707Full label
Dr. Reddy's Laboratories Inc.ANDA212795 · Label 02/24/2023 · NDC 43598-756Full label
GRANULES USA, INC.ANDA210722 · Label 12/22/2025 · NDC 69848-019Full label
Gobrands, IncANDA214684 · Label 01/25/2025 · NDC 82501-1580Full label

Repackager labels (26)

A-S Medication Solutions11/11/2025
A-S Medication Solutions11/10/2025
A-S Medication Solutions11/06/2025
A-S Medication Solutions11/06/2025
A-S Medication Solutions11/06/2025
A-S Medication Solutions12/09/2023
ATLANTIC BIOLOGICALS CORP.02/26/2026
Advanced Rx Pharmacy of Tennessee, LLC12/31/2024
American Health Packaging11/21/2024
Aphena Pharma Solutions - Tennessee, LLC05/13/2020
AvPAK05/21/2026
Bryant Ranch Prepack06/18/2025
Bryant Ranch Prepack06/13/2025
Cardinal Health 107, LLC06/04/2026
Major Pharmaceuticals02/09/2026
Mylan Institutional Inc.07/22/2025
NuCare Pharmaceuticals, Inc.07/14/2026
NuCare Pharmaceuticals,Inc.04/06/2026
NuCare Pharmaceuticals,Inc.03/05/2026
NuCare Pharmaceuticals,Inc.06/10/2024
Preferred Pharmaceuticals Inc05/28/2026
Preferred Pharmaceuticals Inc.05/28/2026
Preferred Pharmaceuticals Inc.05/28/2026
Preferred Pharmaceuticals Inc.04/21/2026
Safecor Health, LLC03/31/2026
St. Mary's Medical Park Pharmacy06/29/2026

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Loratadine: common questions

What is Loratadine used for?: 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
Is Loratadine a prescription drug?: No. Loratadine is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Loratadine?: Yes. Other FDA-listed products with the same active ingredients include allergy relief, Loratadine ODT, Dye-Free Childrens Loratadine, childrens allergy relief.
Who makes Loratadine?: 51 manufacturers list Loratadine with the FDA, including Rite Aid Corporation, AMZ789 LLC, Advagen Pharma Limited.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 09/04/2026 · Label text is shown as published by the manufacturer. Not medical advice

Same active ingredients

Brands and other versions

Data sources

openFDA drug labels (SPL)U.S. Food and Drug Administration
NDC DirectoryDosage forms, strengths and packages
DailyMedFull labels from the National Library of Medicine

Data as of 09/04/2026

Do not rely on openFDA to make decisions regarding medical care. While FDA makes every effort to ensure that data is accurate, all results should be assumed unvalidated. This page is for information only and is not medical advice. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.

Related health info

About this data

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