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PATADAY ONCE DAILY RELIEF

Olopatadine Hydrochloride · Solution

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
PATADAY ONCE DAILY RELIEF
Generic name
Olopatadine Hydrochloride
Dosage form
Solution
Route
Ophthalmic
Marketing category
NDA · NDA
Labeler
Alcon Laboratories, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
8
Data completeness
77% 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 2 mg/mL 1111343 View
Olopatadine Hydrochloride 7 mg/mL 1111343 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Ophthalmic
Presentations
10

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
021545
Application type
NDA · New Drug Application
Approval date
December 22, 2004
Sponsor
ALCON LABS INC
Products on application
1
Submissions recorded
11
Products approved under application 021545.
Product Trade name Form Strength Ingredient Status TE Flags
021545-001 PATADAY ONCE DAILY RELIEF SOLUTION/DROPS OLOPATADINE HYDROCHLORIDE 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 021545.
Type No. Action Status Date Review
Supplement 29 Labeling Approved April 15, 2025 Standard
Supplement 24 Labeling Approved May 13, 2021 Standard
Supplement 23 Labeling Approved September 30, 2020 Standard
Supplement 22 Efficacy Approved February 14, 2020 Standard
Supplement 18 Manufacturing (CMC) Approved October 8, 2015 Standard
Supplement 13 Labeling Approved December 8, 2010 Standard
Supplement 9 Manufacturing (CMC) Approved June 8, 2007 Standard
Supplement 8 Labeling Approved June 8, 2007 Standard
Supplement 6 Labeling Approved April 26, 2007 Standard
Supplement 4 Labeling Approved October 4, 2006 Standard
Original application 1 Type 3 - New Dosage Form Approved December 22, 2004 Standard

Review documents

  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · April 21, 2025
  • 0 · Supplement · April 7, 2022
  • 0 · Supplement · August 4, 2021
  • 0 · Supplement · October 1, 2020
  • 0 · Supplement · February 14, 2020
  • 0 · Supplement · February 14, 2020
  • 0 · Supplement · December 10, 2010
  • 0 · Supplement · December 8, 2010
  • 0 · Supplement · June 14, 2007
  • 0 · Supplement · June 14, 2007
  • 0 · Supplement · June 12, 2007
  • 0 · Supplement · June 12, 2007
  • 0 · Supplement · May 1, 2007
  • 0 · Supplement · May 1, 2007
  • 0 · Original application · February 20, 2007
  • 0 · Original application · December 29, 2004
  • 0 · Original application · December 29, 2004

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260120). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260120 HUMAN OTC DRUG · 20260120

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Active Ingredients Purpose Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily do not use more than 1 drop in each eye 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

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

Active Ingredient

openFDA Drug Labeling

Active Ingredients Purpose Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) Antihistamine

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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II August 17, 2022 Mckesson Medical-Surgical Inc. Corporate Office CGMP Deviations: products were stored outside the drug label specifications. Terminated

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
0065-0816-01 0065-0816 Alcon Laboratories, Inc. 2 BOTTLE, PLASTIC in 1 CARTON (0065-0816-01) / 2.5 mL in 1 BOTTLE, PLASTIC January 4, 2021
0065-0816-02 0065-0816 Alcon Laboratories, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (0065-0816-02) / .5 mL in 1 BOTTLE, PLASTIC January 4, 2021
0065-0816-04 0065-0816 Alcon Laboratories, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (0065-0816-04) / 2.5 mL in 1 BOTTLE, PLASTIC September 1, 2020
0065-0816-12 0065-0816 Alcon Laboratories, Inc. 3 BOTTLE, PLASTIC in 1 CARTON (0065-0816-12) / 2.5 mL in 1 BOTTLE, PLASTIC January 24, 2022
0065-8150-01 0065-8150 Alcon Laboratories, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (0065-8150-01) / 2.5 mL in 1 BOTTLE, PLASTIC February 28, 2020
0065-8150-03 0065-8150 Alcon Laboratories, Inc. 2 BOTTLE, PLASTIC in 1 CARTON (0065-8150-03) / 2.5 mL in 1 BOTTLE, PLASTIC February 28, 2020
0065-8150-04 0065-8150 Alcon Laboratories, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (0065-8150-04) / .5 mL in 1 BOTTLE, PLASTIC February 28, 2020
0065-8150-07 0065-8150 Alcon Laboratories, Inc. 3 BOTTLE, PLASTIC in 1 CARTON (0065-8150-07) / 2.5 mL in 1 BOTTLE, PLASTIC January 15, 2021
0065-0816 0065-0816 Alcon Laboratories, Inc. — September 1, 2020
0065-8150 0065-8150 Alcon Laboratories, Inc. — February 28, 2020

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
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.