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 22 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Maximum Redness Relief and Lubricant	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9feb1818-c79b-23bf-e053-2995a90a1084	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Redness Relief	TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea27a5-b81b-1598-e053-2995a90a6b62	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Seasonal Itching and Redness Relief	TETRAHYDROZOLINE HCI, ZINC SULFATE	Meijer Distribution, Inc.	9fead2de-2fe6-4dab-e053-2995a90a2742	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Meijer Distribution, Inc.	9feb3eec-a36f-8fc7-e053-2a95a90adcd3	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Redness Relief	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9fea4e43-7525-bb66-e053-2a95a90acee9	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Ultra Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	a0846e3e-687c-fd55-e053-2995a90a673e	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Advanced Redness and Irritation Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Meijer Distribution, Inc.	9fea6d7a-a2cd-d26e-e053-2995a90a15f8	2023-12-22	Warnings	Exact identifier application number: M018
Meijer Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Meijer Distribution, Inc.	9feaa5e2-6aca-96e8-e053-2a95a90a54bd	2023-12-22	Warnings	Exact identifier application number: M018
Walgreens Multi-Symptom Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Walgreen Co.	a03789ce-66bd-7b12-e053-2995a90af85a	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Preservative Free	DEXTRAN 70, HYPROMELLOSE	Walgreen Company	9b383e41-e116-1c12-e053-2a95a90ab25f	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Maximum Redness Relief 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	949d4a4d-b0f8-81f8-e053-2995a90a818d	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Seasonal Relief 15mL	TETRAHYDROZOLINE HCI, ZINC SULFATE	Walgreen Co.	947f3706-ef5e-2c53-e053-2a95a90a82bd	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Advanced Relief 15mL	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI	Walgreen Company	949f5560-fba7-2da8-e053-2995a90a23c2	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM	Walgreen Company	9912b773-e7a5-3a82-e053-2995a90a5b2c	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops High Performance 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94ee8310-1c19-dfd4-e053-2a95a90a8356	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Redness Relief Eye Drops 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	94a0d08a-a6db-1088-e053-2995a90ab4fd	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Eye Drops Original 15mL and twin pack	TETRAHYDROZOLINE HCI	Walgreens Company	94e391f7-db4b-47d2-e053-2a95a90a1b11	2023-12-20	Warnings	Exact identifier application number: M018
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94f6e1cd-073c-61ca-e053-2a95a90ae725	2023-12-20	Warnings	Exact identifier application number: M018
Lubricant Eye Drops Preservative Free	CARBOXYMETHYLCELLULOSE SODIUM	Target Corporation	454ce049-49e5-48b1-8499-048e5e7d72d3	2023-12-20	Warnings	Exact identifier application number: M018
Rugby Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rugby Laboratories	f9292d5d-e0a3-9287-e053-6294a90a43e9	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