FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Manufacturer
Walgreens Company
Effective date
2025-12-10
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 01:21:46

Label at a glance#

ProductOlopatadine Hydrochloride Ophthalmic Solution
Active ingredientOLOPATADINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Antihistamine and redness reliever


USES

INDICATIONS & USAGE SECTION

temporarily relieves itchy and red 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 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) 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

OTHER SAFETY INFORMATION

• only for use in the eye  
• store between 4° to 25°C (39° 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?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-7130-05

LabelLabel

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN4
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD4
1111339olopatadine 0.1 % Ophthalmic SolutionSY4
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY4

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-130311917220499GTIN-13: 0311917220499
EAN-13: 0311917220499
GTIN-12: 311917220499
UPC-A: 311917220499
GTIN storage (14 digits): 00311917220499		Walgreens Olopatadine Hcl 5ml Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
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
0363-7130-05Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS14
0363-7130-05Olopatadine Hydrochloride Ophthalmic Solution5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7130-05ML - Milliliter0363-71305c5cf4ba-f6b9-4b53-85ea-79a1d7c045cb12024-10-04
43598-765-07ML - Milliliter43598-7652d0eed44-3338-4d43-b7cd-7d2837bf175012022-05-04

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
0363-71300363-7130-05
43598-765

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OLOPATADINE HYDROCHLORIDE2XG66W44KFACTIM
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM CHLORIDE451W47IQ8XIACT
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 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
A209619-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-0284e616aacf4f…
2026-08-18 06:07:402026-07A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2019-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2019-08-023f01610625f2…
2019-09-15 20:21 UTC2019-09A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2019-08-02b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209619-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A209619-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A209619-001AT1b00525d2431f…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.cc724092-f041-6ecc-2fbf-2a29a9671c892025-12-10WarningsExact identifier
ndc (product): 43598-765
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICWalgreens Company09ef6ddb-c7b8-0f85-1eae-c97de84dc2202025-12-10WarningsExact identifier
ndc (package): 0363-7130-05
ndc (product): 0363-7130
ndc11 (package): 00363713005
spl id: ff7f80c3-e4bc-fc5d-eded-fc4ed2b4565f
spl set id: 09ef6ddb-c7b8-0f85-1eae-c97de84dc220

Reported adverse events (FAERS/openFDA)#

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