Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%

Manufacturer: BluePoint Laboratories | Eugia Pharma Specialities Limited
Effective date: 2022-04-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:49:06

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)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-274-4122

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

✆1-855-274-4122

Manufactured by:

Eugia Pharma Specialities Limited, Unit III
IDA, Pashamylaram – 502307, TS., India.

Code: TS/DRUGS/13/2010

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-520-69
Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE 2.5 mL (0.085 FL OZ)

carton

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-530-69

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

2.5 mL (0.085 FL OZ)

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1111343	olopatadine HCl 0.2 % Ophthalmic Solution	PSN	1
1111343	olopatadine 2 MG/ML Ophthalmic Solution	SCD	1
1111343	olopatadine 0.2 % Ophthalmic Solution	SY	1
1111343	olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OLOPATADINE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20220128

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0368001530699	GTIN-13: 0368001530699 EAN-13: 0368001530699 GTIN-12: 368001530699 UPC-A: 368001530699 GTIN storage (14 digits): 00368001530699	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLN CARTON Rev 03 2022 .jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1	Product name	3	20210312
ee1438f7-d464-b7de-1b3a-aae378f7d672	Product name	8	20200121
4101b788-a943-3f81-6947-4acf7be2af4d	Product name	4	20190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3ee	Product name	1	20150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-530-69	OLOPATADINE HYDROCHLORIDE	1 in 1 CARTON	SOLUTION	1		1
68001-530-69	OLOPATADINE HYDROCHLORIDE	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-530	OLOPATADINE HYDROCHLORIDE SOLUTION [BLUEPOINT LABORATORIES]	1	Current NDC, Legacy NDC, 2 package rows	20220408_dbd28ee2-bbb5-a4b1-e053-2a95a90afff4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-530-69	ML - Milliliter	68001-530	76fb1a0e-9aa9-4276-a6b0-cdd0d1b65d99	1	2022-07-06

Products#

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

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

OLOPATADINE HYDROCHLORIDE
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
EDETATE DISODIUM
HYDROCHLORIC ACID
SODIUM HYDROXIDE
POVIDONE, UNSPECIFIED
SODIUM CHLORIDE
WATER
OLOPATADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68001-530	68001-530-69

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT
OLOPATADINE HYDROCHLORIDE	2XG66W44KF	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209995-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2019-04-04

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209995-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209995-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209995-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209995-001	AT	1	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	dbd28ee2-bbb5-a4b1-e053-2a95a90afff4	2022-04-08	Warnings	Exact identifier ndc (package): 68001-530-69 ndc (product): 68001-530 ndc11 (package): 68001053069 spl id: dbd299b7-11c8-bf59-e053-2a95a90a2cd4 spl set id: dbd28ee2-bbb5-a4b1-e053-2a95a90afff4

Reported adverse events (FAERS/openFDA)#

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