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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Better Living Brands LLC	5d7228ce-f108-4cc2-9aec-8b4548c3a155	2023-12-20	Warnings	Exact identifier application number: M018
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier application number: M018
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Seasonal Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Kroger	f6829be4-e3b7-7ff2-e053-2995a90a80fc	2023-12-20	Warnings	Exact identifier application number: M018
Rite Aid Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Rite Aid Corporation	efa7d208-9d42-13c7-e053-2a95a90a11b3	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Better Living Brands LLC	ea358e01-f03e-454b-bae1-6c83da44c369	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Original Eye Drops	TETRAHYDROZOLINE HCL	Topco Associates LLC	9c61a56a-c1a9-2846-e053-2995a90a755b	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Better Living Brands LLC	f685aca4-93d0-26d9-e053-2995a90a6e51	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Lubricant Eye	CARBOXYMETHYLCELLULOSE SODIUM	The Kroger Co.	046f4ebc-d8f9-4755-b6ba-790fe86f3128	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Ultra Itch Relief Astringent Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	Topco Associates LLC	9c617e34-fc64-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier application number: M018
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
HEB Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	HEB	5d522e4d-d647-486f-a947-25c14b1417fa	2023-12-20	Warnings	Exact identifier application number: M018
HEB A.C. Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	HEB Grocery Company., LP	f680a8c1-dc91-7a52-e053-2a95a90a571e	2023-12-20	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