Indications and uses
temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
OLOPATADINE HYDROCHLORIDE - Sportpharm LLC
- Manufacturer
- Sportpharm LLC
- Effective date
- 2026-04-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:54:59
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) 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° to 25°C (39° to 77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient
Olopatadine (0.1%).
(equivalent to olopatadine hydrochloride, USP 0.111%)
Purpose
Antihistamine and Redness Reliever
Uses
temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
Warnings
For external use only
Do not use
- 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
- 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 ifyou 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.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- 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
- only for use in the eye
- store between 4° to 25°C (39° to 77°F)
Inactive ingredients
benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride and water for injection
Questions?
✆1-855-274-4122
SPL UNCLASSIFIED SECTION
Distributed by:
Sportpharm LLC
379 Van Ness Ave 1401,
Torrance, CA 90501
Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| OLOPATADINE Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20220128 |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85766-111-05 | OLOPATADINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 85766-111-05 | OLOPATADINE HYDROCHLORIDE | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | 2 |
Products#
Every source-derived product name is available through these pages.
- OLOPATADINE HYDROCHLORIDE
- BENZALKONIUM CHLORIDE
- SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
- SODIUM CHLORIDE
- HYDROCHLORIC ACID
- SODIUM HYDROXIDE
- WATER
- OLOPATADINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85766-111 | 85766-111-05 |
| 58602-006 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM | GR686LBA74 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| OLOPATADINE HYDROCHLORIDE | 2XG66W44KF | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-11-09 | monthly-update | 2026-06-03 17:38:20 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204812-001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204812-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-18 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A204812-001 | AT | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A204812-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204812-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204812-001 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | Sportpharm LLC | f0cc699c-545d-4097-b85d-b67ba550863c | 2026-04-24 | Warnings | 85766-111-05 85766-111 85766011105 503209f8-cb9c-5cf2-e063-6394a90a0331 f0cc699c-545d-4097-b85d-b67ba550863c |
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | Aurohealth LLC | 94b1fe3b-6a9b-475a-9c65-1700ce1c2183 | 2025-10-09 | Warnings | 58602-006 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.