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Claritin

Loratadine · Tablet, Orally Disintegrating

Over-the-counter NDA RLD 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
Claritin Reditabs
Generic name
Loratadine
Dosage form
Tablet, Orally Disintegrating
Route
Oral
Marketing category
NDA · NDA
Labeler
Bayer Healthcare LLC.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
10
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
Loratadine 5 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
13

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020704
Application type
NDA · New Drug Application
Approval date
December 23, 1996
Sponsor
BAYER HEALTHCARE LLC
Products on application
2
Submissions recorded
20
Products approved under application 020704.
Product Trade name Form Strength Ingredient Status TE Flags
020704-002 CLARITIN REDITABS TABLET, ORALLY DISINTEGRATING LORATADINE Over-the-counter — RLD RS
020704-003 CLARITIN HIVES RELIEF REDITAB TABLET, ORALLY DISINTEGRATING LORATADINE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020704.
Type No. Action Status Date Review
Supplement 41 Labeling Approved May 25, 2023 Standard
Supplement 37 Labeling Approved January 11, 2021 Standard
Supplement 35 Labeling Approved May 7, 2019 Standard
Supplement 34 Labeling Approved February 28, 2019 Standard
Supplement 33 Labeling Approved July 23, 2018 Standard
Supplement 32 Labeling Approved May 16, 2017 Standard
Supplement 29 Labeling Approved November 4, 2016 Standard
Supplement 28 Labeling Approved November 25, 2015 Standard
Supplement 27 Labeling Approved July 22, 2014 Standard
Supplement 21 Manufacturing (CMC) Approved January 29, 2009 N/A
Supplement 20 Labeling Approved October 21, 2008 Standard
Supplement 14 Manufacturing (CMC) Approved January 19, 2006 Standard
Supplement 9 Efficacy Approved November 19, 2003 Standard
Supplement 8 Efficacy Approved November 27, 2002 Standard
Supplement 7 Manufacturing (CMC) Approved September 18, 2000 Standard
Supplement 4 Manufacturing (CMC) Approved October 29, 1998 Standard
Supplement 1 Manufacturing (CMC) Approved May 29, 1998 Standard
Supplement 3 Manufacturing (CMC) Approved January 23, 1998 Standard
Supplement 2 Manufacturing (CMC) Approved September 19, 1997 Standard
Original application 1 Type 3 - New Dosage Form Approved December 23, 1996 Standard

Review documents

  • 0 · Supplement · May 30, 2023
  • 0 · Supplement · May 26, 2023
  • 0 · Supplement · May 18, 2021
  • 0 · Supplement · January 13, 2021
  • 0 · Supplement · May 8, 2019
  • 0 · Supplement · May 8, 2019
  • 0 · Supplement · March 1, 2019
  • 0 · Supplement · March 1, 2019
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · July 25, 2018
  • 0 · Supplement · May 19, 2017
  • 0 · Supplement · May 19, 2017
  • 0 · Supplement · November 16, 2016
  • 0 · Supplement · November 8, 2016
  • 0 · Supplement · December 1, 2015
  • 0 · Supplement · November 27, 2015
  • 0 · Supplement · July 29, 2014
  • 0 · Supplement · July 24, 2014
  • 0 · Supplement · February 3, 2009
  • 0 · Supplement · October 23, 2008
  • 0 · Supplement · March 2, 2007
  • 0 · Supplement · March 2, 2007
  • 0 · Supplement · January 30, 2006
  • 0 · Supplement · December 7, 2004
  • 0 · Supplement · November 25, 2003
  • 0 · Supplement · November 27, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251205). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251205 HUMAN OTC DRUG · 20251205

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 every 12 hours; not more than 2 tablets 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.

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
11523-7202-1 11523-7202 Bayer HealthCare LLC 3 BLISTER PACK in 1 CARTON (11523-7202-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 12, 2006
11523-7202-3 11523-7202 Bayer HealthCare LLC 1 BLISTER PACK in 1 CARTON (11523-7202-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK December 12, 2006
11523-4329-1 11523-4329 Bayer Healthcare LLC. 2 CARTON in 1 PACKAGE, COMBINATION (11523-4329-1) / 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-4329-2 11523-4329 Bayer Healthcare LLC. 6 BLISTER PACK in 1 CARTON (11523-4329-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7157-2 11523-7157 Bayer Healthcare LLC. 1 BLISTER PACK in 1 CARTON (11523-7157-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7157-3 11523-7157 Bayer Healthcare LLC. 3 BLISTER PACK in 1 CARTON (11523-7157-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7157-4 11523-7157 Bayer Healthcare LLC. 2 BLISTER PACK in 1 CARTON (11523-7157-4) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7157-7 11523-7157 Bayer Healthcare LLC. 4 BLISTER PACK in 1 CARTON (11523-7157-7) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7157-8 11523-7157 Bayer Healthcare LLC. 5 BLISTER PACK in 1 CARTON (11523-7157-8) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7157-9 11523-7157 Bayer Healthcare LLC. 7 BLISTER PACK in 1 CARTON (11523-7157-9) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK November 27, 2002
11523-7202 11523-7202 Bayer HealthCare LLC — December 12, 2006
11523-4329 11523-4329 Bayer Healthcare LLC. — November 27, 2002
11523-7157 11523-7157 Bayer Healthcare LLC. — November 27, 2002

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 · 11 sections on this page.