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ALLERGY RELIEF

loratadine · Tablet, Orally Disintegrating

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ALLERGY RELIEF
Generic name
loratadine
Dosage form
Tablet, Orally Disintegrating
Route
Oral
Marketing category
ANDA · ANDA
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
5
Data completeness
77% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Loratadine 10 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
9

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076011
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 29, 2003
Sponsor
PERRIGO PHARMA INTL
Products on application
1
Submissions recorded
1
Products approved under application 076011.
Product Trade name Form Strength Ingredient Status TE Flags
076011-001 LORATADINE TABLET, ORALLY DISINTEGRATING LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076011.
Type No. Action Status Date Review
Original application 1 Approved September 29, 2003 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20210406). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20210406

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

PURPOSE Antihistamine

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

Do not use If you have ever had an allergic reaction to this product or any of its ingredients.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg

Adverse event reports

Source: openFDA FAERS
114,194
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LORATADINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class III October 21, 2015 Ohm Laboratories, Inc. Superpotent Drug: Out Of Specification (OOS) result for Assay. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
51316-931-46 51316-931 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 10 BLISTER PACK in 1 CARTON (51316-931-46) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK October 6, 2025
51316-931-65 51316-931 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 30 BLISTER PACK in 1 CARTON (51316-931-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK October 6, 2025
30142-446-65 30142-446 Kroger Company 30 BLISTER PACK in 1 CARTON (30142-446-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK June 4, 2021
79481-9723-1 79481-9723 Meijer, Inc. 30 BLISTER PACK in 1 CARTON (79481-9723-1) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK July 6, 2026
51660-527-31 51660-527 Ohm Laboratories Inc. 30 BLISTER PACK in 1 CARTON (51660-527-31) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK August 31, 2007
51316-931 51316-931 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — October 6, 2025
30142-446 30142-446 Kroger Company — June 4, 2021
79481-9723 79481-9723 Meijer, Inc. — July 6, 2026
51660-527 51660-527 Ohm Laboratories Inc. — August 31, 2007

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 11 sections on this page.