Storage and handling
Other information only for use in the eye store between 4°-25°C (39°-77°F)
Other information only for use in the eye store between 4°-25°C (39°-77°F)
Drug Facts
| Active Ingredients | Purpose |
| Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%) | Antihistamine and Redness Reliever |
Use temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
Warnings
For external use only
Do not use
When using this product
Stop use and ask a doctor if you experience:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride and water for injection
Questions?
Customer Care # 1-800-417-9175
Manufactured for:
Somerset Therapeutics, LLC
Somerset, NJ 08873
Made in India
Code No.:KR/DRUGS/KTK/28/289/97
ST-OLP11-OTC/P/01
1200809
Container Label
NDC 70069-017-01
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
TWICE DAILY RELIEF
Eye Allergy Itch & Redness Relief
Sterile
5 mL (0.017 FL OZ)

Carton Label
Original Prescription Strength
NDC 70069-017-01
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
TWICE DAILY RELIEF
Eye Allergy Itch & Redness Relief
TWICE DAILY
Works in Minutes
Relief from Allergens:
• Pet Dander
• Pollen
• Grass
• Ragweed
Sterile
5 mL (0.017 FL OZ

| Class | Version | Type | Effective |
|---|---|---|---|
| OLOPATADINE Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20220128 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70069-017-01 | Olopatadine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 3 | |
| 70069-017-01 | Olopatadine | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 5 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70069-017-01 | ML - Milliliter | 70069-017 | f25cdcca-b8ba-48ca-93a8-08c9dac9cf9e | 1 | 2024-05-16 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70069-017 | 70069-017-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OLOPATADINE HYDROCHLORIDE | 2XG66W44KF | ACTIM |
| SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206306-001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 |
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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206306-001 | 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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A206306-001 | AT | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206306-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206306-001 | AT | 1 | 5aa47cf7b7d7… |
| 2019-12-14 00:12 UTC | 2019-12 | A206306-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206306-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206306-001 | AT | 1 | ea99ee380514… |
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 | OLOPATADINE | Somerset Therapeutics, LLC | 55142e80-c5db-46a5-85a5-e8a040bcc8cf | 2024-03-25 | Warnings | 70069-017-01 70069-017 70069001701 9cb75ee7-d7e0-4f19-8088-05426d8ea407 55142e80-c5db-46a5-85a5-e8a040bcc8cf |
Adverse event summaries are temporarily unavailable. Other product information remains available.