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Claritin

Loratadine · Tablet

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
Generic name
Loratadine
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Bayer HealthCare LLC.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
11
Packages
53
Data completeness
82% 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
Route of administration
Oral
Presentations
64

Regulatory status

Source: Drugs@FDANDC Directory
Application number
019658
Application type
NDA · New Drug Application
Approval date
April 12, 1993
Sponsor
BAYER HEALTHCARE LLC
Products on application
2
Submissions recorded
34
Products approved under application 019658.
Product Trade name Form Strength Ingredient Status TE Flags
019658-002 CLARITIN TABLET LORATADINE Over-the-counter — RLD RS
019658-003 CLARITIN HIVES RELIEF TABLET 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 019658.
Type No. Action Status Date Review
Supplement 62 Labeling Approved April 17, 2025 Standard
Supplement 56 Labeling Approved February 6, 2019 Standard
Supplement 55 Labeling Approved December 21, 2018 Standard
Supplement 54 Labeling Approved October 3, 2018 Standard
Supplement 53 Labeling Approved July 5, 2018 Standard
Supplement 52 Labeling Approved May 30, 2018 Standard
Supplement 51 Labeling Approved May 30, 2018 Standard
Supplement 50 Manufacturing (CMC) Approved January 12, 2018 N/A
Supplement 48 Labeling Approved April 26, 2017 Standard
Supplement 46 Labeling Approved December 14, 2016 Standard
Supplement 45 Labeling Approved August 9, 2016 Standard
Supplement 44 Labeling Approved December 18, 2015 Standard
Supplement 43 Manufacturing (CMC) Approved September 14, 2015 Standard
Supplement 40 Manufacturing (CMC) Approved June 5, 2013 Standard
Supplement 39 Manufacturing (CMC) Approved November 16, 2012 Standard
Supplement 26 Labeling Approved December 20, 2007 Standard
Supplement 20 Efficacy Approved November 19, 2003 Standard
Supplement 21 Labeling Approved June 25, 2003 Standard
Supplement 19 Manufacturing (CMC) Approved December 10, 2002 Standard
Supplement 18 Efficacy Approved November 27, 2002 Standard
Supplement 16 Manufacturing (CMC) Approved July 23, 1999 Standard
Supplement 13 Manufacturing (CMC) Approved January 27, 1999 Standard
Supplement 14 Manufacturing (CMC) Approved October 29, 1998 Standard
Supplement 12 Manufacturing (CMC) Approved May 8, 1998 Standard
Supplement 9 Labeling Approved January 27, 1998 Standard
Supplement 10 Manufacturing (CMC) Approved January 23, 1998 Standard
Supplement 8 Labeling Approved July 14, 1997 Standard
Supplement 1 Labeling Approved September 12, 1996 Standard
Supplement 5 Labeling Approved October 12, 1995 Standard
Supplement 3 Efficacy Approved September 20, 1995 Standard
Supplement 6 Manufacturing (CMC) Approved September 1, 1995 Standard
Supplement 4 Manufacturing (CMC) Approved February 9, 1995 Standard
Supplement 2 Labeling Approved September 17, 1993 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 12, 1993 Standard

Review documents

  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · April 28, 2025
  • 0 · Supplement · March 1, 2019
  • 0 · Supplement · February 20, 2019
  • 0 · Supplement · December 31, 2018
  • 0 · Supplement · December 27, 2018
  • 0 · Supplement · October 15, 2018
  • 0 · Supplement · October 11, 2018
  • 0 · Supplement · July 6, 2018
  • 0 · Supplement · June 1, 2018
  • 0 · Supplement · June 1, 2018
  • 0 · Supplement · June 1, 2018
  • 0 · Supplement · June 1, 2018
  • 0 · Supplement · May 2, 2017
  • 0 · Supplement · May 1, 2017
  • 0 · Supplement · December 19, 2016
  • 0 · Supplement · December 15, 2016
  • 0 · Supplement · August 22, 2016
  • 0 · Supplement · August 9, 2016
  • 0 · Supplement · December 22, 2015
  • 0 · Supplement · December 22, 2015
  • 0 · Supplement · September 18, 2013
  • 0 · Supplement · January 9, 2008
  • 0 · Supplement · March 2, 2007
  • 0 · Supplement · March 2, 2007
  • 0 · Supplement · December 7, 2004
  • 0 · Supplement · November 25, 2003
  • 0 · Supplement · July 6, 2003
  • 0 · Supplement · November 27, 2002
  • 0 · Supplement · May 25, 2001

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251204). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251204 HUMAN OTC DRUG · 20251117 HUMAN OTC DRUG · 20241231

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 ​Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions Directions 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 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 When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children 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 ​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 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 Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

CLARITIN ® Active ingredients (in each tablet) Purpose Loratadine 10 mg Antihistamine

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
11523-6655-1 11523-6655 Bayer HealthCare LLC 1 BLISTER PACK in 1 POUCH (11523-6655-1) / 1 TABLET in 1 BLISTER PACK April 12, 1993
11523-6655-2 11523-6655 Bayer HealthCare LLC 1 BOTTLE in 1 CARTON (11523-6655-2) / 70 TABLET in 1 BOTTLE April 12, 1993
11523-6655-3 11523-6655 Bayer HealthCare LLC 2 BOTTLE in 1 BLISTER PACK (11523-6655-3) / 45 TABLET in 1 BOTTLE April 12, 1993
11523-6655-4 11523-6655 Bayer HealthCare LLC 1 BOTTLE in 1 BLISTER PACK (11523-6655-4) / 105 TABLET in 1 BOTTLE April 12, 1993
11523-6655-5 11523-6655 Bayer HealthCare LLC 1 BOTTLE in 1 CARTON (11523-6655-5) / 60 TABLET in 1 BOTTLE April 12, 1993
11523-6655-6 11523-6655 Bayer HealthCare LLC 1 BOTTLE in 1 BLISTER PACK (11523-6655-6) / 105 TABLET in 1 BOTTLE April 12, 1993
11523-6655-7 11523-6655 Bayer HealthCare LLC 25 POUCH in 1 BOX (11523-6655-7) / 1 TABLET in 1 POUCH April 12, 1993
11523-6655-8 11523-6655 Bayer HealthCare LLC 1 BOTTLE in 1 CARTON (11523-6655-8) / 30 TABLET in 1 BOTTLE April 12, 1993
11523-6655-9 11523-6655 Bayer HealthCare LLC 1 BOTTLE in 1 CARTON (11523-6655-9) / 80 TABLET in 1 BOTTLE April 12, 1993
11523-0007-1 11523-0007 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-0007-1) / 10 TABLET in 1 BLISTER PACK December 1, 2020
11523-0007-2 11523-0007 Bayer HealthCare LLC. 2 BLISTER PACK in 1 CARTON (11523-0007-2) / 10 TABLET in 1 BLISTER PACK December 1, 2020
11523-0007-3 11523-0007 Bayer HealthCare LLC. 30 TABLET in 1 BOTTLE (11523-0007-3) December 1, 2020
11523-0007-4 11523-0007 Bayer HealthCare LLC. 40 TABLET in 1 BOTTLE (11523-0007-4) December 1, 2020
11523-0007-5 11523-0007 Bayer HealthCare LLC. 45 TABLET in 1 BOTTLE (11523-0007-5) December 1, 2020
11523-0007-6 11523-0007 Bayer HealthCare LLC. 70 TABLET in 1 BOTTLE (11523-0007-6) December 1, 2020
11523-0007-7 11523-0007 Bayer HealthCare LLC. 85 TABLET in 1 BOTTLE (11523-0007-7) December 1, 2020
11523-0007-8 11523-0007 Bayer HealthCare LLC. 2 BOTTLE in 1 CARTON (11523-0007-8) / 115 TABLET in 1 BOTTLE July 30, 2021
11523-0007-9 11523-0007 Bayer HealthCare LLC. 60 TABLET in 1 BOTTLE (11523-0007-9) March 16, 2022
11523-0800-1 11523-0800 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACK March 16, 2022
11523-0800-2 11523-0800 Bayer HealthCare LLC. 100 TABLET in 1 BOTTLE (11523-0800-2) March 16, 2022
11523-1527-1 11523-1527 Bayer HealthCare LLC. 50 POUCH in 1 BOX (11523-1527-1) / 1 TABLET in 1 POUCH April 12, 1993
11523-1527-2 11523-1527 Bayer HealthCare LLC. 50 POUCH in 1 BOX (11523-1527-2) / 1 TABLET in 1 POUCH April 12, 1993
11523-4359-1 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-1) / 40 TABLET in 1 BOTTLE April 12, 1993
11523-4359-2 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-2) / 100 TABLET in 1 BOTTLE April 12, 1993
11523-4359-3 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-3) / 90 TABLET in 1 BOTTLE November 1, 2017
11523-4359-4 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-4) / 55 TABLET in 1 BOTTLE February 15, 2019
11523-4359-5 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-5) / 85 TABLET in 1 BOTTLE February 15, 2019
11523-4359-6 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-6) / 110 TABLET in 1 BOTTLE December 1, 2019
11523-4359-7 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 BLISTER PACK (11523-4359-7) / 115 TABLET in 1 BOTTLE April 12, 1993
11523-4359-8 11523-4359 Bayer HealthCare LLC. 2 BOTTLE in 1 BLISTER PACK (11523-4359-8) / 60 TABLET in 1 BOTTLE April 12, 1993
11523-4359-9 11523-4359 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-4359-9) / 35 TABLET in 1 BOTTLE December 1, 2019
11523-7160-1 11523-7160 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-7160-1) / 5 TABLET in 1 BLISTER PACK April 12, 1993
11523-7160-2 11523-7160 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-7160-2) / 10 TABLET in 1 BLISTER PACK April 12, 1993
11523-7160-3 11523-7160 Bayer HealthCare LLC. 2 BLISTER PACK in 1 CARTON (11523-7160-3) / 10 TABLET in 1 BLISTER PACK April 12, 1993
11523-7160-5 11523-7160 Bayer HealthCare LLC. 3 BLISTER PACK in 1 CARTON (11523-7160-5) / 10 TABLET in 1 BLISTER PACK April 12, 1993
11523-7160-6 11523-7160 Bayer HealthCare LLC. 1 POUCH in 1 CARTON (11523-7160-6) / 2 TABLET in 1 POUCH April 12, 1993
11523-7160-7 11523-7160 Bayer HealthCare LLC. 1 BLISTER PACK in 1 POUCH (11523-7160-7) / 1 TABLET in 1 BLISTER PACK April 12, 1993
11523-7160-8 11523-7160 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-7160-8) / 60 TABLET in 1 BOTTLE September 1, 2016
11523-7160-9 11523-7160 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-7160-9) / 60 TABLET in 1 BOTTLE April 12, 1993
11523-7237-1 11523-7237 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-7237-1) / 45 TABLET in 1 BOTTLE April 12, 1993
11523-7237-3 11523-7237 Bayer HealthCare LLC. 7 BLISTER PACK in 1 CARTON (11523-7237-3) / 10 TABLET in 1 BLISTER PACK August 12, 1993
11523-7237-5 11523-7237 Bayer HealthCare LLC. 1 BOTTLE in 1 BLISTER PACK (11523-7237-5) / 90 TABLET in 1 BOTTLE April 12, 1993
11523-7237-6 11523-7237 Bayer HealthCare LLC. 3 BLISTER PACK in 1 CARTON (11523-7237-6) / 5 TABLET in 1 BLISTER PACK April 12, 1993
11523-7237-7 11523-7237 Bayer HealthCare LLC. 4 BLISTER PACK in 1 CARTON (11523-7237-7) / 10 TABLET in 1 BLISTER PACK April 12, 1993
11523-7237-8 11523-7237 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-7237-8) / 108 TABLET in 1 BOTTLE April 12, 1993
11523-7237-9 11523-7237 Bayer HealthCare LLC. 1 BOTTLE in 1 CARTON (11523-7237-9) / 90 TABLET in 1 BOTTLE October 5, 2017
66715-9742-1 66715-9742 Lil' Drug Store Products, Inc. 1 POUCH in 1 CARTON (66715-9742-1) / 1 TABLET in 1 POUCH June 1, 2022
66715-9742-2 66715-9742 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-9742-2) / 1 TABLET in 1 POUCH June 1, 2022
67751-153-01 67751-153 Navajo Manufacturing Company Inc. 1 POUCH in 1 CARTON (67751-153-01) / 1 TABLET in 1 POUCH September 17, 2016
70264-030-01 70264-030 R J General Corporation 25 POUCH in 1 CARTON (70264-030-01) / 1 TABLET in 1 POUCH December 26, 2022
85237-1630-1 85237-1630 Select Consumer Group 1 BLISTER PACK in 1 CARTON (85237-1630-1) / 1 TABLET in 1 BLISTER PACK August 18, 2025
85237-1630-3 85237-1630 Select Consumer Group 20 POUCH in 1 BOX, UNIT-DOSE (85237-1630-3) / 1 TABLET in 1 POUCH December 27, 2025
85237-1630-4 85237-1630 Select Consumer Group 25 POUCH in 1 BOX, UNIT-DOSE (85237-1630-4) / 1 TABLET in 1 POUCH December 27, 2025
11523-6655 11523-6655 Bayer HealthCare LLC — April 12, 1993
11523-0007 11523-0007 Bayer HealthCare LLC. — December 1, 2020
11523-0800 11523-0800 Bayer HealthCare LLC. — December 1, 2020
11523-1527 11523-1527 Bayer HealthCare LLC. — April 12, 1993
11523-4359 11523-4359 Bayer HealthCare LLC. — April 12, 1993
11523-7160 11523-7160 Bayer HealthCare LLC. — April 12, 1993
11523-7237 11523-7237 Bayer HealthCare LLC. — April 12, 1993
66715-9742 66715-9742 Lil' Drug Store Products, Inc. — June 1, 2022
67751-153 67751-153 Navajo Manufacturing Company Inc. — September 17, 2016
70264-030 70264-030 R J General Corporation — March 1, 2021
85237-1630 85237-1630 Select Consumer Group — December 1, 2020

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.