FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Manufacturer
BluePoint Laboratories | SamChunDang Pharm Co, Ltd
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:18

Label at a glance#

ProductOLOPATADINE HYDROCHLORIDE
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure12 sections

Dosage and administration

adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily, no more than once 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

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients

  • Purpose

Olopatadine 0.2%
(equivalent to olopatadine hydrochloride 0.222%)

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
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 - DO NOT USE 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

OTC - STOP USE SECTION

Stop use and ask a doctor ifyou experience:

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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, no more than once 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection

Questions?

OTC - QUESTIONS SECTION

In the U.S., call toll free weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Manufactured by: SamChunDang Pharm. Co., Ltd.
71 Jeyakgongdan-2Gil; Hyangnam-eup, Hwaseong,
Gyeonggi 18622, Korea, South (KOR)
For BluePoint Laboratories

Product of Spain

Rev 08/25

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

ONCE DAILY RELIEF

Olopatadine hydrochloride ophthalmic solution 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL

NDC: 68001-674-92

Label

Olopatadine 0.2 LabelOlopatadine 0.2 Label

Original Prescription Strength

ONCE DAILY RELIEF

Olopatadine hydrochloride ophthalmic solution 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL

NDC: 68001-674-92

Carton

Olopatadine 0.2 CartonOlopatadine 0.2 Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN2
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD2
1111343olopatadine 0.2 % Ophthalmic SolutionSY2
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 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
BarcodeEAN-130368001674928GTIN-13: 0368001674928
EAN-13: 0368001674928
GTIN-12: 368001674928
UPC-A: 368001674928
GTIN storage (14 digits): 00368001674928		Olopatadine 0.2 Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-674-92OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION12
68001-674-92OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-674-92ML - Milliliter68001-6740ef4909c-5b9b-43a7-b4f5-ece1ea8b985d12025-10-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68001-67468001-674-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
POVIDONE K30U725QWY32XIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
WATER059QF0KO0RIACT
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM

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 43.

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
A219557-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28

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
2026-09-14 22:38:342026-08A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219557-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2025-02-28a50c72e98297…

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 HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBluePoint Laboratories3e86783f-0001-625f-e063-6294a90acd202026-03-25WarningsExact identifier
ndc (package): 68001-674-92
ndc (product): 68001-674
ndc11 (package): 68001067492
spl id: 4ddbb9c6-87d6-317b-e063-6294a90a7375
spl set id: 3e86783f-0001-625f-e063-6294a90acd20

Reported adverse events (FAERS/openFDA)#

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