Patanol

Product NDC: 0065-0271
Requested package NDC: 0065-0271-05
11-digit product format: 000650271
Labeler code: 0065
Product ID: 0065-0271_144a0240-0655-4a63-aee2-e6d4e563a378
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olopatadine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA020688
Marketing category: NDA
Marketing start: 1997-02-17
Marketing end: 2021-03-31
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0065-0271	0065-0271-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020688-001	PATADAY TWICE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`e64feba35796…`

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	N020688-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020688-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020688-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020688-001	AT	1	`ea99ee380514…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0271-05	ML - Milliliter	0065-0271	fbac5306-f0bc-4f14-a94c-3d57a7e0baaf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OLOPATADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2XG66W44KF	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
OLOPATADINE	ACTIVE MOIETY	D27V6190PM	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]	5
OLOPATADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2XG66W44KF	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
OLOPATADINE	ACTIVE MOIETY	D27V6190PM	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PATANOL (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1

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
PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	b7a24375-25df-4405-aa7c-34c46af51194	2026-01-20	Warnings	Exact identifier application applno (NDA): 020688 application number: NDA020688

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2XG66W44KF	OLOPATADINE HYDROCHLORIDE	140462-76-6	OLOPATADINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111339	olopatadine HCl 0.1 % Ophthalmic Solution	PSN	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111341	Patanol 0.1 % Ophthalmic Solution	PSN	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111341	olopatadine 1 MG/ML Ophthalmic Solution [Patanol]	SBD	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111341	Patanol 0.1 % Ophthalmic Solution	SY	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111341	Patanol 1 MG/ML (olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1
1111341	Patanol 1 MG/ML Ophthalmic Solution	SY	ae8b4a9d-4308-4a3c-8ec9-1e8d9060db68	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0271-05	00065027105	5 mL in 1 BOTTLE, PLASTIC (0065-0271-05)	5 ml	1997-02-17	2021-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PATANOL ® (olopatadine hydrochloride ophthalmic solution) 0.1%	Alcon Laboratories, Inc.	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	10
Patanol ® (olopatadine hydrochloride ophthalmic solution) 0.1%	A-S Medication Solutions	2017-10-13	HUMAN PRESCRIPTION DRUG LABEL	4
PATANOL - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-05-12	HUMAN PRESCRIPTION DRUG LABEL	1