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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Visine Red Eye Total Comfort Multi-Symptom	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM	Kenvue Brands LLC	5747edef-7a87-41d7-9594-6c78508b9ba2	2026-06-11	Warnings	Exact identifier application number: M018
Nano Eye Drop Serum	WATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.	Shenzhen Yiyang Zhiting Technology Co., Ltd	539567d6-488a-9b01-e063-6394a90abece	2026-06-06	Warnings	Exact identifier application number: M018
REFRESH CELLUVISC	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	b32ed9e8-d091-4f16-b416-5a62cdfee49a	2026-06-05	Warnings	Exact identifier application number: M018
VitaPhyte Redness Reliever Lubricant Eye Drops	REDNESS RELIEVER LUBRICANT EYE DROPS	Guangzhou Liyan Cosmetics Technology Co., Ltd.	53d4e9b0-c9a0-797a-e063-6294a90ad0cf	2026-06-04	Warnings	Exact identifier application number: M018
Rohto Digi-Eye	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE	The Mentholatum Company	5d6f37b9-b568-4cb6-92de-eb40779f3f8c	2026-06-03	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Savings Distributors LLC	558178eb-1eec-af0f-e063-6394a90afad9	2026-06-01	Warnings	Exact identifier application number: M018
C-More Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	PROFOUND NUTRITION LIMITED	78f04ecb-da5e-468c-81fe-70f7c26b76c2	2026-06-01	Warnings	Exact identifier application number: M018
Peep Club	GLYCERIN	Peep Club Eyecare Corp.	513d1988-2827-28d8-e063-6294a90a8d1f	2026-05-28	Warnings	Exact identifier application number: M018
Blink Triple Care Preservative Free	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	65e67990-78b7-4ce9-963b-6bed3a6bed07	2026-05-27	Warnings	Exact identifier application number: M018
Ripple	GLYCERIN, POVIDONE	CorneaCare Inc	3b5ba197-d501-681e-e063-6294a90aefb5	2026-05-24	Warnings	Exact identifier application number: M018
REFRESH LACRI-LUBE	MINERAL OIL, PETROLATUM	Allergan, Inc.	d232a44b-516d-4cdf-a4e7-c3a9a50dc7af	2026-05-15	Warnings	Exact identifier application number: M018
blink tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	f1d07347-086f-43b2-aa5f-910764fc666e	2026-05-13	Warnings	Exact identifier application number: M018
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1	2026-05-12	Warnings	Exact identifier application number: M018
Sodium Hyaluronate Eye Drops	SODIUM HYALURONATE	Guangzhou Hechuang Commercial Service Co.,Ltd.	5187d136-15c6-517b-e063-6294a90a811d	2026-05-11	Warnings	Exact identifier application number: M018
Splash Tears	HYPROMELLOSE	LABORATORIOS SOPHIA, S.A. DE C.V.	a58a8478-9cc5-aa39-e053-2995a90a347d	2026-05-08	Warnings	Exact identifier application number: M018
iVIZIA Lubricant Eye Gel	POVIDONE	Thea Pharma Inc.	1f06ca1a-5270-9a82-e063-6294a90aed64	2026-04-29	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Preferred PHarmaceuticals Inc.	011473a8-26d5-4661-b3c0-745f9b6aa1d8	2026-04-29	Warnings	Exact identifier application number: M018
REFRESH TEARS PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Allergan, Inc.	9e1cba7b-84ed-47f3-b19a-121992834350	2026-04-24	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE	Method Pharmaceuticals, LLC	4b08859e-65bd-8255-e063-6394a90af614	2026-04-23	Warnings	Exact identifier application number: M018
Pure Eyes Sterile Eyes	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	SAMSON PHARMACEUTICAL	c0234e82-211f-4731-ac48-12db13b16e8a	2026-04-21	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