FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Manufacturer
GLENMARK THERAPEUTICS INC., USA | SamChunDang Pharm Co, Ltd
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:34:49

Label at a glance#

ProductOLOPATADINE HYDROCHLORIDE
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure12 sections

Dosage and administration

• adults and children 2 years of age and older: o put 1 drop in the affected eye(s) once daily, no more than once per day o if using other ophthalmic products while using this product, wait at least 5 minutes between each product o 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

Use temporarily 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 if you 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

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Product of Spain

07/2025

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-194-25

Olopatadine HCl Ophthalmic Solution 0.2% 

Antihistamine

Once Daily
STERILE

2.5 mL (0.085 FL OZ)

label
label

NDC: 72657-194-25

Original Prescription Strength

ONCE DAILY

Olopatadine HCl Ophthalmic Solution, USP 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL (0.085 FL OZ)

carton
carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN3
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD3
1111343olopatadine 0.2 % Ophthalmic SolutionSY3
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY3

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-130372657194259GTIN-13: 0372657194259
EAN-13: 0372657194259
GTIN-12: 372657194259
UPC-A: 372657194259
GTIN storage (14 digits): 00372657194259		label.jpg, carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72657-194-11OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.53
72657-194-11OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION23
72657-194-25OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.53
72657-194-25OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-194-11ML - Milliliter72657-1942910b6f7-7fcc-4cfb-bb57-78cfe505874a12025-08-11
72657-194-25ML - Milliliter72657-194ec6b27c2-545f-4c03-b85e-b3764fbf084e12025-08-11

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
72657-19472657-194-25, 72657-194-11

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
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
POVIDONE K30U725QWY32XIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
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 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 HYDROCHLORIDEGLENMARK THERAPEUTICS INC., USA07e8b359-d4ae-4b5b-81dc-c7e57e172c582026-01-27WarningsExact identifier
ndc (package): 72657-194-11
ndc (package): 72657-194-25
ndc (product): 72657-194
ndc11 (package): 72657019411
ndc11 (package): 72657019425
spl id: 5ce14b14-b893-4d56-a19e-b1788b17074f
spl set id: 07e8b359-d4ae-4b5b-81dc-c7e57e172c58

Reported adverse events (FAERS/openFDA)#

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