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 01:37:46

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) twice daily, every 6 to 8 hours, no more than twice 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 4°C to 25°C (39°F to 77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient

Purpose

Olopatadine (0.1%).
(equivalent to olopatadine hydrochloride 0.111%)

Antihistamine and redness reliever

INDICATIONS & USAGE SECTION

Uses

temporarily relieves itchy and red 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) twice daily, every 6 to 8 hours, no more than twice 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 4°C to 25°C (39°F to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.

Questions or comments?

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

07/25

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief

STERILE

5 mL (0.17 FL OZ)

carton
carton


NDC 72657-168-50

Olopatadine HCl Ophthalmic Solution,USP 0.1%

Antihistamine and Redness Reliever

Twice Daily


STERILE
5 mL (0.17 FL OZ)

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN3
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD3
1111339olopatadine 0.1 % Ophthalmic SolutionSY3
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 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-130372657168502GTIN-13: 0372657168502
EAN-13: 0372657168502
GTIN-12: 372657168502
UPC-A: 372657168502
GTIN storage (14 digits): 00372657168502
carton.jpg, 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
72657-168-50OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLE, PLASTICSOLUTION53
72657-168-50OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-168-50ML - Milliliter72657-16839a2f61c-ab94-4431-92e3-b7beea40ac5212025-08-11

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72657-16872657-168-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
A200810-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28c2088c7a36db…
2026-09-14 22:38:342026-08A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-2884e616aacf4f…
2026-08-18 06:07:402026-07A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2017-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200810-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2017-06-283a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A200810-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200810-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A200810-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200810-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200810-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200810-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A200810-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200810-001AT1ea99ee380514…

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 HYDROCHLORIDE OPHTHALMICGLENMARK THERAPEUTICS INC., USAa80c3fd2-47b7-4ed0-b862-9c50996846072026-01-27WarningsExact identifier
ndc (package): 72657-168-50
ndc (product): 72657-168
ndc11 (package): 72657016850
spl id: bc82a9d3-2fd3-4a7d-9126-c0f07a610b05
spl set id: a80c3fd2-47b7-4ed0-b862-9c5099684607

Reported adverse events (FAERS/openFDA)#

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