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Claritin

Loratadine · Tablet, Chewable

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, Chewable
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
4
Packages
20
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 5 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
24

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021891
Application type
NDA · New Drug Application
Approval date
August 23, 2006
Sponsor
BAYER HEALTHCARE LLC
Products on application
2
Submissions recorded
27
Products approved under application 021891.
Product Trade name Form Strength Ingredient Status TE Flags
021891-001 CHILDREN'S CLARITIN TABLET, CHEWABLE LORATADINE Over-the-counter — RLD
021891-002 CLARITIN TABLET, CHEWABLE 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 021891.
Type No. Action Status Date Review
Supplement 47 Labeling Approved May 20, 2026 Standard
Supplement 45 Labeling Approved May 14, 2025 Standard
Supplement 46 Manufacturing (CMC) Approved April 17, 2025 N/A
Supplement 44 Manufacturing (CMC) Approved July 11, 2024 N/A
Supplement 43 Labeling Approved December 27, 2022 Standard
Supplement 38 Labeling Approved April 2, 2021 Standard
Supplement 36 Labeling Approved January 7, 2021 Standard
Supplement 34 Labeling Approved August 7, 2020 Standard
Supplement 32 Manufacturing (CMC) Approved November 7, 2019 N/A
Supplement 33 Labeling Approved October 3, 2019 Standard
Supplement 31 Labeling Approved June 17, 2019 Standard
Supplement 28 Labeling Approved January 3, 2019 Standard
Supplement 29 Manufacturing (CMC) Approved November 21, 2018 N/A
Supplement 27 Labeling Approved July 20, 2018 Standard
Supplement 26 Labeling Approved February 15, 2018 Standard
Supplement 23 Labeling Approved May 22, 2017 Standard
Supplement 21 Labeling Approved April 5, 2016 Standard
Supplement 20 Labeling Approved December 23, 2015 Standard
Supplement 19 Manufacturing (CMC) Approved September 24, 2015 N/A
Supplement 18 Labeling Approved July 25, 2014 Standard
Supplement 17 Manufacturing (CMC) Approved September 10, 2013 Standard
Supplement 16 Manufacturing (CMC) Approved March 26, 2013 Standard
Supplement 15 Manufacturing (CMC) Approved January 4, 2013 Standard
Supplement 8 Type 3 - New Dosage Form Approved March 3, 2010 Standard
Supplement 4 Labeling Approved October 21, 2008 Standard
Supplement 5 Manufacturing (CMC) Approved October 8, 2008 Standard
Original application 1 Type 3 - New Dosage Form Approved August 23, 2006 Standard

Review documents

  • 0 · Supplement · May 21, 2026
  • 0 · Supplement · May 21, 2026
  • 0 · Supplement · April 27, 2026
  • 0 · Supplement · April 27, 2026
  • 0 · Supplement · May 23, 2025
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · April 28, 2025
  • 0 · Supplement · September 23, 2024
  • 0 · Supplement · September 23, 2024
  • 0 · Supplement · January 3, 2023
  • 0 · Supplement · December 28, 2022
  • 0 · Supplement · July 21, 2021
  • 0 · Supplement · April 28, 2021
  • 0 · Supplement · April 6, 2021
  • 0 · Supplement · March 4, 2021
  • 0 · Supplement · January 8, 2021
  • 0 · Supplement · August 10, 2020
  • 0 · Supplement · December 11, 2019
  • 0 · Supplement · December 11, 2019
  • 0 · Supplement · October 7, 2019
  • 0 · Supplement · October 7, 2019
  • 0 · Supplement · June 18, 2019
  • 0 · Supplement · June 18, 2019
  • 0 · Supplement · January 4, 2019
  • 0 · Supplement · January 4, 2019
  • 0 · Supplement · December 30, 2018
  • 0 · Supplement · December 12, 2018
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · July 23, 2018
  • 0 · Supplement · March 15, 2018

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 · 20251204

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 adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 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 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

AS a doctor before use if you have 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 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 5 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
11523-0104-1 11523-0104 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-0104-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK February 8, 2023
11523-0104-2 11523-0104 Bayer HealthCare LLC. 2 BLISTER PACK in 1 CARTON (11523-0104-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK February 8, 2023
11523-0104-3 11523-0104 Bayer HealthCare LLC. 3 BLISTER PACK in 1 CARTON (11523-0104-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK February 8, 2023
11523-0104-4 11523-0104 Bayer HealthCare LLC. 4 BLISTER PACK in 1 CARTON (11523-0104-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK February 8, 2023
11523-0104-5 11523-0104 Bayer HealthCare LLC. 6 BLISTER PACK in 1 CARTON (11523-0104-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK February 8, 2023
11523-0104-6 11523-0104 Bayer HealthCare LLC. 8 BLISTER PACK in 1 CARTON (11523-0104-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK February 5, 2023
11523-4328-1 11523-4328 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-4328-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4328-2 11523-4328 Bayer HealthCare LLC. 2 BLISTER PACK in 1 CARTON (11523-4328-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4328-3 11523-4328 Bayer HealthCare LLC. 3 BLISTER PACK in 1 CARTON (11523-4328-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4328-4 11523-4328 Bayer HealthCare LLC. 1 BLISTER PACK in 1 POUCH (11523-4328-4) / 2 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4328-5 11523-4328 Bayer HealthCare LLC. 5 BLISTER PACK in 1 CARTON (11523-4328-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4328-6 11523-4328 Bayer HealthCare LLC. 50 POUCH in 1 BOX (11523-4328-6) / 2 TABLET, CHEWABLE in 1 POUCH August 23, 2006
11523-4328-7 11523-4328 Bayer HealthCare LLC. 2.5 BLISTER PACK in 1 PACKAGE, COMBINATION (11523-4328-7) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4328-9 11523-4328 Bayer HealthCare LLC. 4 BLISTER PACK in 1 CARTON (11523-4328-9) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4330-1 11523-4330 Bayer HealthCare LLC. 1 BLISTER PACK in 1 CARTON (11523-4330-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 25, 2015
11523-4330-3 11523-4330 Bayer HealthCare LLC. 3 BLISTER PACK in 1 CARTON (11523-4330-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 25, 2015
11523-4330-4 11523-4330 Bayer HealthCare LLC. 4 BLISTER PACK in 1 CARTON (11523-4330-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 25, 2015
11523-4331-1 11523-4331 Bayer HealthCare LLC. 4 BLISTER PACK in 1 CARTON (11523-4331-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-4331-2 11523-4331 Bayer HealthCare LLC. 6 BLISTER PACK in 1 CARTON (11523-4331-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK September 6, 2019
11523-4331-6 11523-4331 Bayer HealthCare LLC. 8 BLISTER PACK in 1 CARTON (11523-4331-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK August 23, 2006
11523-0104 11523-0104 Bayer HealthCare LLC. — February 5, 2023
11523-4328 11523-4328 Bayer HealthCare LLC. — August 23, 2006
11523-4330 11523-4330 Bayer HealthCare LLC. — September 25, 2015
11523-4331 11523-4331 Bayer HealthCare LLC. — August 23, 2006

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.