OLOPATADINE HYDROCHLORIDE

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
OLOPATADINE HYDROCHLORIDE
Generic name
OLOPATADINE HYDROCHLORIDE
Manufacturer
Allegiant Health
Product type
HUMAN OTC DRUG
SPL set ID
fdb808ef-9d5f-4bc3-86e7-f519b5c75a46
SPL ID
94283fa2-f59d-4cfd-9f02-e4aaf60382ca
Version
2
Effective date
2025-05-05
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:26:00
Harmonized routes table
Harmonized routes
OPHTHALMIC

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use if you have 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 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.