Olopatadine — Solution/ Drops

Overview

Brand name

Olopatadine

Generic name

Olopatadine

Dosage form

Solution/ Drops

Route

Ophthalmic

Marketing category

ANDA · ANDA

Labeler

A-S Medication Solutions

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

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

4

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@FDA NDC Directory

Application number

206306

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 7, 2015

Sponsor

SOMERSET THERAPS LLC

Products on application

1

Submissions recorded

2

Products approved under application 206306.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
206306-001	OLOPATADINE HYDROCHLORIDE	SOLUTION/DROPS		OLOPATADINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 206306.
Type	No.	Action	Status	Date	Review
Supplement	11	Labeling	Approved	April 9, 2024	Standard
Original application	1		Approved	December 7, 2015	Standard

Review documents

0 · Original application · December 9, 2015

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260508). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260508

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Drug Facts Active Ingredients Purpose Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%) 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 if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red Stop use and ask a doctor if you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours

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
50090-7959-0	50090-7959	A-S Medication Solutions	1 BOTTLE, PLASTIC in 1 CARTON (50090-7959-0) / 5 mL in 1 BOTTLE, PLASTIC	May 5, 2026
70069-017-01	70069-017	Somerset Therapeutics, LLC	1 BOTTLE, PLASTIC in 1 CARTON (70069-017-01) / 5 mL in 1 BOTTLE, PLASTIC	April 15, 2024
50090-7959	50090-7959	A-S Medication Solutions	—	April 15, 2024
70069-017	70069-017	Somerset Therapeutics, LLC	—	April 15, 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 · 10 sections on this page.