FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Manufacturer
Retail Business Services, LLC. | Aurobindo Pharma Limited
Effective date
2021-04-01
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:24

Label at a glance#

ProductOLOPATADINE HYDROCHLORIDE
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, 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° to 25°C (36° to 77°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride, USP 0.222%)

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 you experience:

OTC - STOP USE SECTION

  • 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 (1-800-222-1222) 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° to 25°C (36° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

✆ 1-866-850-2876

DISTRIBUTED BY:
FOODHOLD U.S.A., LLC,
LANDOVER, MD 20785
MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone        NDC 72476-851-21
EYE ALLERGY ITCH RELIEF
Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.2%
Antihistamine
STERILE           2.5 mL (0.085 FL OZ)


olopatadine-figure-1
olopatadine-figure-1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

                                         NDC 72476-851-21
CAREone
 Compare to the Active Ingredient in
Pataday® Once Daily Relief

 EYE ALLERGY
ITCH RELIEF
Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.2%

ONCE DAILY
Now available without a prescription
Antihistamine
Works in Minutes
Relief from Allergens:
Pet Dander, Pollen, Grass, Ragweed

STERILE
2.5 mL (0.085 FL OZ)


olopatadine-figure-2
olopatadine-figure-2

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

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
72476-851-21OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION12
72476-851-21OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-851OLOPATADINE HYDROCHLORIDE SOLUTION [RETAIL BUSINESS SERVICES, LLC.]2Current NDC, Legacy NDC, 2 package rows20210403_bca27f6a-d1b1-1d6a-e053-2995a90a37b5.zip

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
72476-85172476-851-21

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 HYDROCHLORIDE2XG66W44KFACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM CHLORIDE451W47IQ8XIACT
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
A209995-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0484e616aacf4f…
2026-08-18 06:07:402026-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-043f01610625f2…
2019-09-15 20:21 UTC2019-09A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMICAT2019-04-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209995-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A209995-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A209995-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209995-001AT1ea99ee380514…

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 HYDROCHLORIDERetail Business Services, LLC.bca27f6a-d1b1-1d6a-e053-2995a90a37b52021-04-01WarningsExact identifier
ndc (package): 72476-851-21
ndc (product): 72476-851
ndc11 (package): 72476085121
spl id: bca27f6a-d1b1-1d6a-e053-2995a90a37b5
spl set id: bca27f6a-d1b1-1d6a-e053-2995a90a37b5

Reported adverse events (FAERS/openFDA)#

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