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Olopatadine Hydrochloride Ophthalmic Solution

Olopatadine Hydrochloride Ophthalmic · Solution

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
Olopatadine Hydrochloride Ophthalmic Solution
Generic name
Olopatadine Hydrochloride Ophthalmic
Dosage form
Solution
Route
Ophthalmic
Marketing category
ANDA · ANDA
Labeler
Chain Drug Marketing Association INC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
13
Packages
16
Data completeness
82% 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
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
29

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
209752
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 20, 2020
Sponsor
GLAND
Products on application
1
Submissions recorded
1
Products approved under application 209752.
Product Trade name Form Strength Ingredient Status TE Flags
209752-001 OLOPATADINE HYDROCHLORIDE SOLUTION/DROPS OLOPATADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209752.
Type No. Action Status Date Review
Original application 1 Approved May 20, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260115). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260115 HUMAN OTC DRUG · 20251216 HUMAN OTC DRUG · 20250414 HUMAN OTC DRUG · 20241028

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 Other Information only for use in the eye store between 4-25 °C (39-77 °F) protect from light

Warnings

openFDA Drug Labeling

Warnings For external use only 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

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 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 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
21130-105-02 21130-105 Albertsons Companies 1 BOTTLE, PLASTIC in 1 CARTON (21130-105-02) / 2.5 mL in 1 BOTTLE, PLASTIC June 25, 2021
24208-966-01 24208-966 Bausch & Lomb Incorporated 1 BOTTLE in 1 CARTON (24208-966-01) / 5 mL in 1 BOTTLE December 2, 2024
24208-966-02 24208-966 Bausch & Lomb Incorporated 2 BOTTLE in 1 CARTON (24208-966-02) / 5 mL in 1 BOTTLE December 2, 2024
51316-567-01 51316-567 CVS Pharmacy 1 BOTTLE in 1 CARTON (51316-567-01) / 2.5 mL in 1 BOTTLE January 15, 2026
63868-821-25 63868-821 Chain Drug Marketing Association INC 1 BOTTLE, PLASTIC in 1 CARTON (63868-821-25) / 2.5 mL in 1 BOTTLE, PLASTIC January 1, 2021
83324-120-25 83324-120 Chain Drug Marketing Association INC 1 BOTTLE, PLASTIC in 1 CARTON (83324-120-25) / 2.5 mL in 1 BOTTLE, PLASTIC September 3, 2024
55910-137-25 55910-137 DOLGENCORP, LLC 1 BOTTLE, PLASTIC in 1 CARTON (55910-137-25) / 2.5 mL in 1 BOTTLE, PLASTIC December 1, 2021
43598-764-02 43598-764 Dr. Reddy's Laboratories Inc. 1 BOTTLE, PLASTIC in 1 CARTON (43598-764-02) / 2.5 mL in 1 BOTTLE, PLASTIC September 1, 2020
43598-764-25 43598-764 Dr. Reddy's Laboratories Inc. 2 BOTTLE, PLASTIC in 1 CARTON (43598-764-25) / 2.5 mL in 1 BOTTLE, PLASTIC September 1, 2020
68083-231-01 68083-231 Gland Pharma Limited 1 BOTTLE, PLASTIC in 1 CARTON (68083-231-01) / 2.5 mL in 1 BOTTLE, PLASTIC May 20, 2020
68083-398-01 68083-398 Gland Pharma Limited 1 BOTTLE, PLASTIC in 1 CARTON (68083-398-01) / 2.5 mL in 1 BOTTLE, PLASTIC January 6, 2026
11822-9975-2 11822-9975 Rite Aid Corporation 1 BOTTLE, PLASTIC in 1 CARTON (11822-9975-2) / 2.5 mL in 1 BOTTLE, PLASTIC October 8, 2020
82442-967-02 82442-967 TARGET CORPORATION 1 BOTTLE, PLASTIC in 1 CARTON (82442-967-02) / 3.5 mL in 1 BOTTLE, PLASTIC April 15, 2025
11673-688-25 11673-688 Target Corporation 1 BOTTLE, PLASTIC in 1 CARTON (11673-688-25) / 2.5 mL in 1 BOTTLE, PLASTIC September 16, 2021
0363-0867-01 0363-0867 WALGREEN COMPANY 1 BOTTLE in 1 CARTON (0363-0867-01) / 5 mL in 1 BOTTLE December 22, 2025
0363-7131-25 0363-7131 Walgreens Company 1 BOTTLE, PLASTIC in 1 CARTON (0363-7131-25) / 2.5 mL in 1 BOTTLE, PLASTIC October 1, 2020
21130-105 21130-105 Albertsons Companies — June 25, 2021
24208-966 24208-966 Bausch & Lomb Incorporated — December 2, 2024
51316-567 51316-567 CVS Pharmacy — January 15, 2026
63868-821 63868-821 Chain Drug Marketing Association INC — January 1, 2021
83324-120 83324-120 Chain Drug Marketing Association INC — January 1, 2021
55910-137 55910-137 DOLGENCORP, LLC — December 1, 2021
43598-764 43598-764 Dr. Reddy's Laboratories Inc. — August 19, 2020
68083-231 68083-231 Gland Pharma Limited — August 20, 2020
11822-9975 11822-9975 Rite Aid Corporation — October 8, 2020
82442-967 82442-967 TARGET CORPORATION — April 15, 2025
11673-688 11673-688 Target Corporation — September 16, 2021
0363-0867 0363-0867 WALGREEN COMPANY — December 22, 2025
0363-7131 0363-7131 Walgreens Company — October 1, 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

Generated September 25, 2026 · 11 sections on this page.