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Loratadine 10mg

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
Loratadine 10mg
Generic name
Loratadine 10mg
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Allegiant Health
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
14
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
Route of administration
Oral
Presentations
18

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211718
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 28, 2023
Sponsor
HETERO LABS LTD V
Products on application
1
Submissions recorded
1
Products approved under application 211718.
Product Trade name Form Strength Ingredient Status TE Flags
211718-001 LORATADINE TABLET LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 211718.
Type No. Action Status Date Review
Original application 1 Approved July 28, 2023 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251219). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20241125 HUMAN OTC DRUG · 20200616

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 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 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. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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

ASK A DOCTOR BEFORE USE IF 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 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(S) 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.

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
69168-475-02 69168-475 Allegiant Health 150 TABLET in 1 BOTTLE (69168-475-02) March 18, 2025
69168-475-05 69168-475 Allegiant Health 500 TABLET in 1 BOTTLE (69168-475-05) November 11, 2025
69168-475-08 69168-475 Allegiant Health 1 BLISTER PACK in 1 CARTON (69168-475-08) / 5 TABLET in 1 BLISTER PACK September 30, 2025
69168-475-09 69168-475 Allegiant Health 1 BLISTER PACK in 1 CARTON (69168-475-09) / 10 TABLET in 1 BLISTER PACK September 30, 2025
69168-475-17 69168-475 Allegiant Health 300 TABLET in 1 BOTTLE (69168-475-17) September 30, 2025
69168-475-30 69168-475 Allegiant Health 1 BOTTLE in 1 CARTON (69168-475-30) / 30 TABLET in 1 BOTTLE September 30, 2025
69168-475-60 69168-475 Allegiant Health 60 TABLET in 1 BOTTLE (69168-475-60) September 30, 2025
69168-475-99 69168-475 Allegiant Health 365 TABLET in 1 BOTTLE (69168-475-99) September 30, 2025
21130-932-65 21130-932 BETTER LIVING BRANDS, LLC 1 BOTTLE in 1 CARTON (21130-932-65) / 365 TABLET in 1 BOTTLE April 18, 2026
25000-092-03 25000-092 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLE November 21, 2024
25000-092-79 25000-092 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLE November 21, 2024
25000-092-80 25000-092 MARKSANS PHARMA LIMITED 365 TABLET in 1 BOTTLE (25000-092-80) November 21, 2024
25000-092-81 25000-092 MARKSANS PHARMA LIMITED 2 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK November 21, 2024
79481-7870-3 79481-7870 Meijer 70 TABLET in 1 BOTTLE (79481-7870-3) September 9, 2024
69168-475 69168-475 Allegiant Health — March 18, 2025
21130-932 21130-932 BETTER LIVING BRANDS, LLC — April 18, 2026
25000-092 25000-092 MARKSANS PHARMA LIMITED — November 21, 2024
79481-7870 79481-7870 Meijer — September 9, 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.