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 11 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCI	Retail Business Services, LLC	9ab96aed-21d3-11b6-e053-2995a90a7225	2025-12-30	Warnings	Exact identifier application number: M018
CVS Lubricant Eye Drops 30 ct	CARBOXYMETHYLCELLULOSE SODUIM	CVS Pharmacy, Inc.	8dbca077-c989-767a-e053-2995a90a7cf5	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Original Formula Eye Drops	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	002da62b-aec6-8e2a-e063-6294a90a5efc	2025-12-30	Warnings	Exact identifier application number: M018
CareOne Artificial Tears Eye Drops 15mL	POLYVINYL ALCOHOL, POVIDONE	Retail Business Services, LLC	92fded6b-91fd-d82e-e053-2a95a90ab523	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Long Lasting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	00546df0-17d8-0e3c-e063-6294a90ae7b2	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Meijer, Inc.	e7a5677a-ff33-c039-e053-2a95a90ae6c7	2025-12-30	Warnings	Exact identifier application number: M018
TopCare Health Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Topcare Associates LLC	e8e9dfe5-3540-a4df-e053-2a95a90aaf98	2025-12-30	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Meijer Distribution, Inc.	b245f99f-785a-efdc-e053-2995a90a4911	2025-12-30	Warnings	Exact identifier application number: M018
Equate Original Eye Drops	TETRAHYDROZOLINE HCL	Walmart, Inc.	eb8e5beb-4454-58c2-e053-2a95a90a66e0	2025-12-30	Warnings	Exact identifier application number: M018
Avenova Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	NovaBay Pharmaceuticals, Inc.	cd17f037-5aa5-0ef8-e053-2a95a90a39cb	2025-12-30	Warnings	Exact identifier application number: M018
Equate Redness and Dry Eye Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Wal-Mart Stores, Inc.	ae228018-9238-2cbd-e053-2995a90a8d99	2025-12-30	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walmart, Inc.	deebaf7f-f20d-4d7f-e053-2a95a90a4b4f	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Artificial Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Chain Drug Marketing Association, Inc.	1f669655-4bc7-0175-e063-6294a90a305a	2025-12-30	Warnings	Exact identifier application number: M018
Equate Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Walmart, Inc.	ead9f271-0f15-1fff-e053-2a95a90a93ac	2025-12-30	Warnings	Exact identifier application number: M018
Equate Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATE	Walmart, Inc.	eb8ed76b-9cd7-3636-e053-2a95a90a9583	2025-12-30	Warnings	Exact identifier application number: M018
CorneaCare Recover Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CorneaCare Inc.	1fd3a5ed-8963-5c8e-e063-6394a90a6527	2025-12-30	Warnings	Exact identifier application number: M018
Eye Love Heyedrate Long Lasting Hydration	GLYCERIN, POVIDONE	Physician Recommended Neutraceuticals, L.P.	f321dea1-3251-eaa8-e053-2995a90aaf95	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Chain Drug Marketing Assoc., Inc.	0cd1b36a-a07a-a1db-e063-6294a90a5994	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Quality Choice	1f682079-6e91-e14b-e063-6394a90a3f12	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Moisturizing Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Chain Drug Marketing Association, Inc.	1fb81759-5931-59c8-e063-6294a90a2277	2025-12-30	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