Olopatadine Hcl

Manufacturer: Sola Pharmaceuticals
Effective date: 2025-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:20:44

Label at a glance#

ProductOlopatadine Hcl

Active ingredientOLOPATADINE HYDROCHLORIDE

Label structure13 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 opthalmic 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

Contacts and useful links#

PhoneLabel contact1-866-747-7365

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride, USP 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 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 our 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 opthalmic 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°- 25°C (39°- 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-747-7365

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for:

SOLA Pharmaceuticals LLC,

Baton Rouge, LA 70810

Made in India

Code No: DD/DRUGS/DD/292

Olopatadine Hcl Opthalmic Solution 0.1% Bottle Label:

Bottle Label

Olopatadine Hcl Opthalmic Solution 0.1% Carton Label:

Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1111339	olopatadine HCl 0.1 % Ophthalmic Solution	PSN	6
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	6
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	6
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	6

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	0705120520055	GTIN-13: 0705120520055 EAN-13: 0705120520055 GTIN-12: 705120520055 UPC-A: 705120520055 GTIN storage (14 digits): 00705120520055	Listing copy Olopatadine HCI Opthalmic Sol_5ml_3016699_INR_APVL_0421 copy.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
70512-520-05	Olopatadine Hcl	1 in 1 CARTON	SOLUTION/ DROPS	1		6
70512-520-05	Olopatadine Hcl	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70512-520-05	ML - Milliliter	70512-520	46dfc2c6-64bc-4e64-abf6-bdd00830719a	1	2022-08-04

Products#

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

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

Olopatadine Hcl
BENZALKONIUM CHLORIDE
WATER
SODIUM HYDROXIDE
SODIUM CHLORIDE
OLOPATADINE HYDROCHLORIDE
OLOPATADINE
SODIUM PHOSPHATE, DIBASIC
HYDROCHLORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70512-520	70512-520-05

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
OLOPATADINE HYDROCHLORIDE	2XG66W44KF	ACTIB
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT

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
A203152-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2015-12-07

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	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203152-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`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	A203152-001	AT	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203152-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203152-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203152-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203152-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203152-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203152-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203152-001	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 Hcl	OLOPATADINE HCL	Sola Pharmaceuticals	e314e745-1e83-a530-e053-2995a90a67b4	2025-12-08	Warnings	Exact identifier ndc (package): 70512-520-05 ndc (product): 70512-520 ndc11 (package): 70512052005 spl id: 45728450-eb13-7314-e063-6394a90ae6d1 spl set id: e314e745-1e83-a530-e053-2995a90a67b4

Reported adverse events (FAERS/openFDA)#

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