Prescription and over-the-counter medicine

Olopatadine Brand names: Pataday; first approved as Pataday Twice Daily Relief

Olopatadine (Pataday) is a prescription and over-the-counter medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $2.96 per mL (Olopatadine HCl 0.2% eye drop) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the olopatadine FDA label on DailyMed (effective January 20, 2026, Alcon Laboratories, Inc.); the NDA 20688 record on Drugs@FDA; every olopatadine label on DailyMed.

Highlights of the record

FDA label of January 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Forms and strengths

1 mg/ml
2 mg/ml
5 mg/2.5ml
7 mg/ml

Solution; solution/ drops; spray; spray (metered).

On the market

Earliest approval on file: December 18, 1996 Pataday Twice Daily Relief, Alcon Labs Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 29 first October 8, 2014; 22 with a marketed status in Drugs@FDA
Labelers listed (NDC): 48 of which 47 under generic applications, 1 under brand applications, repackagers included
Last listed patent: May 19, 2032 Pataday Once Daily Relief solution/drops; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $2.96 per mL Olopatadine HCl 0.2% eye drop
Shortage (FDA): No current entry
Recalls by its makers (FDA): 6 since 2022 0 Class I among all firms' recalls; latest October 13, 2022; 2 more by firms not listed as its makers
FAERS reports: 8,480 through July 30, 2026

What is olopatadine used for?

From the label: indications and usage
temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Conditions named in the indications of olopatadine's FDA labels, with every medicine labeled for each:

Allergies

From other olopatadine labels
Allergies: Olopatadine hydrochloride nasal solution (nasal spray) is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.

FDA pharmacologic class: Histamine-1 Receptor Antagonist, Histamine-1 Receptor Inhibitor and Mast Cell Stabilizer.

Source: FDA drug label (PATADAY ONCE DAILY RELIEF), Alcon Laboratories, Inc., effective January 20, 2026 (SPL set 1c7d2342-ba1c-4244-9814-d92a05725d4e), via openFDA; the full label on DailyMed

What does the patient leaflet for olopatadine say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using olopatadine hydrochloride nasal spray?
Olopatadine hydrochloride nasal spray can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how olopatadine hydrochloride nasal spray affects you. • Do not drink alcohol or take any medicines that may cause you to feel sleepy while using olopatadine hydrochloride nasal spray. It may make your sleepiness worse. Do not drink alcohol or take any medicines that may cause you to feel sleepy while using olopatadine hydrochloride nasal spray. It may make your sleepiness worse.

From the patient leaflet: How should I store olopatadine hydrochloride nasal spray?
Store olopatadine hydrochloride nasal spray at room temperature between 39°F to 77°F (4°C to 25°C). • Do not use your olopatadine hydrochloride nasal spray after the expiration date on the label or box. Do not use your olopatadine hydrochloride nasal spray after the expiration date on the label or box. Keep olopatadine hydrochloride nasal spray and all medicines out of the reach of children.

Source: FDA drug label (olopatadine hydrochloride), Padagis Israel Pharmaceuticals Ltd, effective September 1, 2023 (SPL set 126ff6eb-62ae-46f2-ab1e-7ac19346c36b), via openFDA; the full label on DailyMed

Is there a generic for olopatadine (Pataday)?

The FDA approved the first generic olopatadine on October 8, 2014. 29 generic applications are approved; 22 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists olopatadine from 47 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 2 patents for Pataday Once Daily Relief solution/drops, the last expiring on May 19, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1996 earliest approval on file
2014 first generic approved
2032 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for olopatadine (Pataday)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.96 per mL (Olopatadine HCl 0.2% eye drop), down 20% from $3.68 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Olopatadine HCl 0.2% eye drop (generic)
Pataday twice daily 0.1% drops (brand)

$3.77

$2.46

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Advanced eye relief 0.2% drops	Generic	$1.98 per mL	n/a	n/a
Ft eye allergy itch rlf 0.2%	Generic	$2.96 per mL	n/a	-20%
Ft eye allergy itch-red 0.1%	Generic	$1.27 per mL	n/a	no change
Gnp olopatadine 0.1% eye drops	Generic	$1.27 per mL	n/a	no change
Gnp olopatadine 0.2% eye drop	Generic	$2.96 per mL	n/a	-20%
Olopatadine 665 mcg nasal spry	Generic	$0.850 per gram	n/a	-6%
Olopatadine HCl 0.1% eye drop	Generic	$1.27 per mL	n/a	no change
Olopatadine HCl 0.1% eye drops	Generic	$1.27 per mL	n/a	no change
Olopatadine HCl 0.2% eye drop	Generic	$2.96 per mL	n/a	-20%
Pataday once daily 0.2% drops	Brand	$5.89 per mL	n/a	+0.6%
Pataday once daily 0.7% drops	Brand	$6.20 per mL	n/a	+1%
Pataday twice daily 0.1% drops	Brand	$2.48 per mL	n/a	no change

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has olopatadine been recalled?

The FDA's Enforcement Report lists 8 recalls naming olopatadine since 2022: 0 Class I (the most serious), 8 Class II, 0 Class III; 7 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of olopatadine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
April 26, 2023	Class II	Akorn, Inc. not a listed maker	CGMP Deviations: Firm went out of business and could no longer continue stability studies.
October 13, 2022	Class II	Akorn, Inc.	CGMP Deviations:
June 29, 2022	Class II	Mckesson Medical-Surgical Inc. Corporate Office	CGMP Deviations: products were stored outside the drug label specifications.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for olopatadine?

The FDA Adverse Event Reporting System holds 8,480 reports that list olopatadine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 329 are coded as a death and 1,571 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (2,795, against a median of 627 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

Treatment Failure (a use or a product term, not a reaction)2,513
Drug Ineffective (a use or a product term, not a reaction)773
Eye Irritation344
Headache (named in the label)295
Vision Blurred261
Nausea259
Rash (named in the label)241
Fatigue (named in the label)240

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

How does olopatadine compare with medicines for the same use?

2 side-by-side pages set olopatadine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Other antihistamines: the pharmacologic class, with prices and generics
Olopatadine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other