FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Manufacturer
Gland Pharma Limited
Effective date
2026-01-07
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:49

Label at a glance#

ProductOlopatadine Hydrochloride Ophthalmic Solution
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure13 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#

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 A 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.

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 5minutes 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° - 25°C (36° - 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 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label:

EXTRA STRENGTH

NDC 68083-398-01
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
Eye Allergy Itch Relief

FULL
24
HOUR

Works in Minutes
2.5 mL (0.085 fl oz)
STERILE 


olopatadine-spl-cartonolopatadine-spl-carton



Bottle Label:
 NDC 68083-398-01
EXTRA STRENGTH
 Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
0.7%
Antihistamine
ONCE DAILY RELIEF
EYE ALLERGY ITCH RELIEF

STERILE

2.5 mL (0.085 fl oz)

olopatadine-spl-bottleolopatadine-spl-bottle




DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSN2
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCD2
1601086olopatadine 0.7 % Ophthalmic SolutionSY2
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Stacked(01)00368083398019GTIN-14: 00368083398019
GTIN-12: 368083398019
UPC-A: 368083398019
EAN-13: 0368083398019
GTIN storage (14 digits): 00368083398019		olopatadine-spl-bottle.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-398-01Olopatadine Hydrochloride Ophthalmic Solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52
68083-398-01Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION12

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
68083-39868083-398-01

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
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICGland Pharma Limiteda3475f8c-c780-43c0-b22f-08a0ce5608fd2026-01-07WarningsExact identifier
ndc (package): 68083-398-01
ndc (product): 68083-398
ndc11 (package): 68083039801
spl id: e05ea1df-8db8-4261-be59-8f303da3b57e
spl set id: a3475f8c-c780-43c0-b22f-08a0ce5608fd

Reported adverse events (FAERS/openFDA)#

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