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Eye Allergy Itch and Redness Relief

Olopatadine Hydrochloride Ophthalmic · Solution/ Drops

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
Eye Allergy Itch and Redness Relief
Generic name
Olopatadine Hydrochloride Ophthalmic
Dosage form
Solution/ Drops
Route
Ophthalmic
Marketing category
ANDA · ANDA
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
Packages
3
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
Olopatadine Hydrochloride 1 mg/mL 1111343 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution/ Drops
Route of administration
Ophthalmic
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Histamine Release [PE] PE All 16 members
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members
Histamine-1 Receptor Inhibitor [EPC] EPC All 19 members
Mast Cell Stabilizer [EPC] EPC All 16 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209619
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 2, 2019
Sponsor
GLAND
Products on application
1
Submissions recorded
2
Products approved under application 209619.
Product Trade name Form Strength Ingredient Status TE Flags
209619-001 OLOPATADINE HYDROCHLORIDE SOLUTION/DROPS OLOPATADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209619.
Type No. Action Status Date Review
Supplement 1 Labeling Approved May 7, 2020 Standard
Original application 1 Approved August 2, 2019 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251210). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251210

Indications and Usage

openFDA Drug Labeling

USES temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Purpose

openFDA Drug Labeling

PURPOSE Antihistamine and redness reliever

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS • adults and children 2 years of age and older: • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • replace cap after each use • children under 2 years of age: consult a doctor

Warnings

openFDA Drug Labeling

WARNINGS For external use only

Do Not Use

openFDA Drug Labeling

DO NOT USE • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation

Stop Use

openFDA Drug Labeling

STOP USE AND ASK DOCTOR IF you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Adverse event reports

Source: openFDA FAERS
7,693
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: OLOPATADINE HYDROCHLORIDE. 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
70000-0054-1 70000-0054 CARDINAL HEALTH 110, LLC. DBA LEADER 1 BOTTLE, DROPPER in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, DROPPER January 15, 2021
43598-826-07 43598-826 Dr. Reddy's Laboratories Inc. 1 BOTTLE, PLASTIC in 1 CARTON (43598-826-07) / 5 mL in 1 BOTTLE, PLASTIC October 1, 2020
70677-1156-1 70677-1156 Strategic Sourcing Services LLC 1 BOTTLE, PLASTIC in 1 CARTON (70677-1156-1) / 5 mL in 1 BOTTLE, PLASTIC August 4, 2023
70000-0054 70000-0054 CARDINAL HEALTH 110, LLC. DBA LEADER — January 15, 2021
43598-826 43598-826 Dr. Reddy's Laboratories Inc. — October 1, 2020
70677-1156 70677-1156 Strategic Sourcing Services LLC — March 15, 2021

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 · 10 sections on this page.