FDA.reportPublic FDA data

Eye Allergy Itch Relief

Manufacturer
Walgreen Company
Effective date
2026-01-15
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 01:33:14

Label at a glance#

ProductEye Allergy Itch Relief
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure14 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)

PURPOSE

OTC - PURPOSE SECTION

Antihistamine


USE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

• 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

OTC - WHEN USING SECTION

• 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 DOCTOR IF

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER INFORMATION

OTHER SAFETY INFORMATION

• only for use in the eye
• store between 2° to 25°C (36° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl gamma cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone and purified water.

QUESTIONS?

OTC - QUESTIONS SECTION

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Distributed by:

WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com 1-800-925-4733 ©2025 Walgreen Co.

MADE IN INDIA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label:


EXTRA STRENGTH
Eye Allergy Itch Relief

Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief
2.5 mL (0.085 fl oz)
Sterile 

PlaceholderPlaceholder




Bottle Label:

EXTRA STRENGTH
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief
2.5 mL (0.085 fl oz)
Sterile 

Placeholder
Placeholder

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSN1
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCD1
1601086olopatadine 0.7 % Ophthalmic SolutionSY1
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OLOPATADINE Pharmacologic Class Indexing4Indexing - Pharmacologic Class20220128

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-13250363-1325-02, 0363-1325-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
HYDROCHLORIC ACIDQTT17582CBIACT
HYDROXYPROPYL .GAMMA.-CYCLODEXTRINP6BYU725IUIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
MANNITOL3OWL53L36AIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213514-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06c2088c7a36db…
2026-09-14 22:38:342026-08A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-0684e616aacf4f…
2026-08-18 06:07:402026-07A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICWalgreen Company56a99d87-b88b-d140-2dc7-08af5a9f45fb2026-01-15WarningsExact identifier
ndc (package): 0363-1325-02
ndc (package): 0363-1325-01
ndc (product): 0363-1325
ndc11 (package): 00363132502
ndc11 (package): 00363132501
spl id: 728c16c0-cc2b-10c0-6ee8-cedb095a0c4b
spl set id: 56a99d87-b88b-d140-2dc7-08af5a9f45fb

Reported adverse events (FAERS/openFDA)#

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