Alavert — Tablet, Orally Disintegrating

Overview

Brand name

Alavert Allergy

Generic name

Loratadine

Dosage form

Tablet, Orally Disintegrating

Route

Oral

Marketing category

NDA · NDA

Labeler

Foundation Consumer Brands

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

4

Packages

6

Data completeness

76% 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

10

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

021375

Application type

NDA · New Drug Application

Approval date

December 19, 2002

Sponsor

FDN CONSUMER

Products on application

1

Submissions recorded

2

Products approved under application 021375.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
021375-001	ALAVERT	TABLET, ORALLY DISINTEGRATING		LORATADINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 021375.
Type	No.	Action	Status	Date	Review
Supplement	2	Manufacturing (CMC)	Approved	August 19, 2005	Standard
Original application	1	Type 3 - New Dosage Form	Approved	December 19, 2002	Standard

Review documents

0 · Supplement · August 23, 2005
0 · Original application · May 26, 2004
0 · Original application · March 24, 2004
0 · Original application · April 9, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240624). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240624 HUMAN OTC DRUG · 20240501

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions Place 1 tablet on tongue; tablet disentigrates with or without water. adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers who have 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 use more than directed. Taking more than recommended 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.

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 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.

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
80070-110-18	80070-110	Foundation Consumer Brands	18 BLISTER PACK in 1 CARTON (80070-110-18) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	April 2, 2021
80070-110-60	80070-110	Foundation Consumer Brands	60 BLISTER PACK in 1 CARTON (80070-110-60) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	April 2, 2021
80070-120-60	80070-120	Foundation Consumer Brands	60 BLISTER PACK in 1 CARTON (80070-120-60) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	April 2, 2021
69536-190-60	69536-190	Foundation Consumer Healthcare	60 BLISTER PACK in 1 CARTON (69536-190-60) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	May 15, 2024
69536-195-20	69536-195	Foundation Consumer Healthcare	20 BLISTER PACK in 1 CARTON (69536-195-20) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	October 31, 2024
69536-195-60	69536-195	Foundation Consumer Healthcare	60 BLISTER PACK in 1 CARTON (69536-195-60) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	October 31, 2024
80070-110	80070-110	Foundation Consumer Brands	—	April 2, 2021
80070-120	80070-120	Foundation Consumer Brands	—	April 2, 2021
69536-190	69536-190	Foundation Consumer Healthcare	—	May 1, 2024
69536-195	69536-195	Foundation Consumer Healthcare	—	October 31, 2024

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

Generated September 25, 2026 · 9 sections on this page.