PATADAY ONCE DAILY RELIEF

Product NDC
0065-0816
11-digit product format
000650816
Labeler code
0065
Product ID
0065-0816_d735b7f6-185e-4fbb-a640-0f8aa8c57f45
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA206276
Marketing category
NDA
Marketing start
2020-09-01
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
7 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N206276-001PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206276-00187911542032-05-19U-1680Drug product2015-03-31
N206276-00195330532032-05-19Drug product2020-08-31

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
2026-08-18 06:07:402026-07N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206276-001PAZEOEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206276-001PAZEOEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09N206276-001PAZEOEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N206276-001PAZEOEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206276-001PATADAY ONCE DAILY RELIEFEQ 0.7% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2015-01-30e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N206276-00187911542032-05-19U-1680Drug product2015-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N206276-00195330532032-05-19Drug product2020-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206276-00187911542032-05-19U-1680Drug product2015-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206276-00195330532032-05-19Drug product2020-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206276-00187911542032-05-19U-1680Drug product2015-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206276-00195330532032-05-19Drug product2020-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206276-00187911542032-05-19U-1680Drug product2015-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206276-00195330532032-05-19Drug product2020-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206276-00187911542032-05-19U-1680Drug product2015-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206276-00195330532032-05-19Drug product2020-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206276-00187911542032-05-19U-1680Drug product2015-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206276-00195330532032-05-19Drug product2020-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206276-00187911542032-05-19U-1680Drug product2015-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206276-00195330532032-05-19Drug product2020-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206276-00187911542032-05-19U-1680Drug product2015-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206276-00195330532032-05-19Drug product2020-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206276-00187911542032-05-19U-1680Drug product2015-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206276-00195330532032-05-19Drug product2020-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206276-00187911542032-05-19U-1680Drug product2015-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206276-00195330532032-05-19Drug product2020-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206276-00187911542032-05-19U-1680Drug product2015-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N206276-00195330532032-05-19Drug product2020-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206276-00187911542032-05-19U-1680Drug product2015-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206276-00195330532032-05-19Drug product2020-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206276-00187911542032-05-19U-1680Drug product2015-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206276-00195330532032-05-19Drug product2020-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206276-00187911542032-05-19U-1680Drug product2015-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206276-00195330532032-05-19Drug product2020-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206276-00187911542032-05-19U-1680Drug product2015-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206276-00195330532032-05-19Drug product2020-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206276-00187911542032-05-19U-1680Drug product2015-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206276-00195330532032-05-19Drug product2020-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206276-00187911542032-05-19U-1680Drug product2015-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206276-00195330532032-05-19Drug product2020-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206276-00187911542032-05-19U-1680Drug product2015-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206276-00195330532032-05-19Drug product2020-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206276-00187911542032-05-19U-1680Drug product2015-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206276-00195330532032-05-19Drug product2017-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206276-00187911542032-05-19U-1680Drug product2015-03-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N206276-00195330532032-05-19Drug product2020-08-31bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
PATADAY ONCE DAILY RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE7 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2XG66W44KFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1601086Internal RxNorm lookup
2474007Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d07a5d6-265c-4735-97b3-8a2575b276cbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0816-01PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0065-0816-01PATADAY ONCE DAILY RELIEF2 in 1 CARTONSOLUTION25
0065-0816-02PATADAY ONCE DAILY RELIEF0.5 mL in 1 BOTTLE, PLASTICSOLUTION0.55
0065-0816-02PATADAY ONCE DAILY RELIEF1 in 1 CARTONSOLUTION15
0065-0816-04PATADAY ONCE DAILY RELIEF1 in 1 CARTONSOLUTION15
0065-0816-04PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0065-0816-12PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0065-0816-12PATADAY ONCE DAILY RELIEF3 in 1 CARTONSOLUTION35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0816-01ML - Milliliter0065-081667d8c896-9796-4b84-ba8b-04479fa63b4812021-02-05
0065-0816-04ML - Milliliter0065-0816f59821f4-37e3-4ac5-b7d8-7dc76c6d3aeb12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0816PATADAY ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]4Current NDC, Legacy NDC, 8 package rows20220626_6d07a5d6-265c-4735-97b3-8a2575b276cb.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.6d07a5d6-265c-4735-97b3-8a2575b276cb2026-01-20WarningsExact identifier
application applno (NDA): 206276
application number: NDA206276
ndc (product): 0065-0816

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSN6d07a5d6-265c-4735-97b3-8a2575b276cb5
2474007Pataday 0.7 % Ophthalmic SolutionPSN6d07a5d6-265c-4735-97b3-8a2575b276cb5
2474007olopatadine 7 MG/ML Ophthalmic Solution [Pataday]SBD6d07a5d6-265c-4735-97b3-8a2575b276cb5
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCD6d07a5d6-265c-4735-97b3-8a2575b276cb5
1601086olopatadine 0.7 % Ophthalmic SolutionSY6d07a5d6-265c-4735-97b3-8a2575b276cb5
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSY6d07a5d6-265c-4735-97b3-8a2575b276cb5
2474007Pataday 7 MG/ML Ophthalmic SolutionSY6d07a5d6-265c-4735-97b3-8a2575b276cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-0816-01000650816012 BOTTLE, PLASTIC in 1 CARTON (0065-0816-01) / 2.5 mL in 1 BOTTLE, PLASTIC2021-01-040000-00-00NoNoCurrent
0065-0816-02000650816021 BOTTLE, PLASTIC in 1 CARTON (0065-0816-02) / .5 mL in 1 BOTTLE, PLASTIC2021-01-040000-00-00NoNoCurrent
0065-0816-04000650816041 BOTTLE, PLASTIC in 1 CARTON (0065-0816-04) / 2.5 mL in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent
0065-0816-12000650816123 BOTTLE, PLASTIC in 1 CARTON (0065-0816-12) / 2.5 mL in 1 BOTTLE, PLASTIC2022-01-240000-00-00NoNoCurrent