Systane Nighttime

Product NDC: 0065-0509
11-digit product format: 000650509
Labeler code: 0065
Product ID: 0065-0509_6be68481-baa0-4f9c-897b-acb1c6090af7
Type: HUMAN OTC DRUG
Nonproprietary name: mineral oil and white petrolatum
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-06-26
Substance: MINERAL OIL; PETROLATUM
Active strength: 30; 940 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Systane Nighttime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	30 mg/g
PETROLATUM	940 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
706820	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4689c59c-5721-3f91-6c85-e41501998fd0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0509-35	Systane Nighttime	3.5 g in 1 TUBE	OINTMENT	3.5		10
0065-0509-35	Systane Nighttime	1 in 1 CARTON	OINTMENT	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0509-35	GM - Gram	0065-0509	72e9b105-4b60-4b9a-8253-b8b27f9e8fa5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mineral Oil	ACTIVE INGREDIENT	T5L8T28FGP	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	2
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	2
Mineral Oil	ACTIVE MOIETY	T5L8T28FGP	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	2
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	2
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0509	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20241208_4689c59c-5721-3f91-6c85-e41501998fd0.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 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Eyes Natural Tears	POLYVINYL ALCOHOL AND POVIDONE	Prestige Brands Holdings, Inc.	efba3eb0-798d-4635-b19b-4970e45b3cc9	2024-04-01	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol	POLYVINYL ALCOHOL	A-S Medication Solutions	c77589fd-f68d-48b7-bd12-51f6b4cc9402	2024-03-20	Warnings	Exact identifier application number: M018
REFRESH CLASSIC	POLYVINYL ALCOHOL, POVIDONE	A-S Medication Solutions	3bf6193c-56db-45ad-844c-58eb8c33cba9	2024-03-14	Warnings	Exact identifier application number: M018
GOODSENSE ARTIFICIAL TEARS	POLYVINYL ALCOHOL	Proficient Rx LP	f29c792c-6cb2-449f-b97d-6304a58dec2a	2024-02-01	Warnings	Exact identifier application number: M018
GoodSense Artifical Tears	POLYVINYL ALCOHOL, AND POVIDONE	Proficient Rx LP	cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9	2024-02-01	Warnings	Exact identifier application number: M018
GENTEAL TEARS	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	A-S Medication Solutions	a2b715e9-332d-4f0b-b8e5-ebc000681586	2024-01-21	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort, CVP	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS	Lil' Drug Store Products, Inc.	0f50bcc8-3658-8c2c-e063-6294a90a8e13	2024-01-19	Warnings	Exact identifier application number: M018
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier application number: M018
Exchange Select Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Army and Air Force Exchange Service	318bc025-c936-a066-e063-6294a90a4712	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Original	TETRAHYDROZOLINE HCL	The Kroger Co.	318c17a1-fe08-508b-e063-6394a90a2e08	2024-01-01	Warnings	Exact identifier application number: M018
HEB Original Eye Drops	TETRAHYDROZOLINE HCL	HEB Grocery Company, LP	318cb457-bb2d-a1ee-e063-6294a90a8019	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart, Inc.	318dc92a-0707-d6a4-e063-6294a90ab78a	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	The Kroger Co.	318dea21-2656-36a3-e063-6294a90ac9c4	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Original	TETRAHYDROZOLINE HCL	Harris Teeter, LLC.P	31a1b962-27ad-97b1-e063-6294a90a77f1	2024-01-01	Warnings	Exact identifier application number: M018
CVP Sterile Eye Drops	TETRAHYDROZOLINE HCL	Salado Sales, Inc.	31a216f8-28e9-ec8f-e063-6394a90aec49	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Sterile Eye Drops	TETRAHYDROZOLINE HCL	United Natural Foods, Inc.	31a25efb-a627-1a13-e063-6394a90a2ca3	2024-01-01	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Original	TETRAHYDROZOLINE HCL	Valu Merchandisers Company	31a2a42a-bcfe-4f22-e063-6294a90ac60e	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Original	TETRAHYDROZOLINE HCL	Discount Drug Mart, Inc.	31a2efb2-3924-6a12-e063-6394a90ab0e2	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Redness Relief Lubricant Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	United Natural Foods, Inc	31a30b00-9f4b-717a-e063-6394a90a8a87	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC.	31a3d575-10f1-5feb-e063-6294a90ac478	2024-01-01	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
706820	mineral oil 3 % / petrolatum 94 % Ophthalmic Ointment	PSN	4689c59c-5721-3f91-6c85-e41501998fd0	10
706820	mineral oil 0.03 MG/MG / petrolatum 0.94 MG/MG Ophthalmic Ointment	SCD	4689c59c-5721-3f91-6c85-e41501998fd0	10
706820	mineral oil 3 % / petrolatum, white 94 % Ophthalmic Ointment	SY	4689c59c-5721-3f91-6c85-e41501998fd0	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0509-35	00065050935	1 TUBE in 1 CARTON (0065-0509-35) / 3.5 g in 1 TUBE	1 tube	2008-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Systane ® Nighttime Drug Facts	Alcon Laboratories, Inc. \| Novartis Manufacturing \| Siegfried El Masnou, S.A.	2024-12-05	HUMAN OTC DRUG LABEL	10