FDA.reportPublic FDA data

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
IngredientStrength
MINERAL OIL30 mg/g
PETROLATUM940 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4689c59c-5721-3f91-6c85-e41501998fd0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0509-35Systane Nighttime3.5 g in 1 TUBEOINTMENT3.510
0065-0509-35Systane Nighttime1 in 1 CARTONOINTMENT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0509-35GM - Gram0065-050972e9b105-4b60-4b9a-8253-b8b27f9e8fa512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGPSYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]2
PetrolatumACTIVE INGREDIENT4T6H12BN9USYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]2
Mineral OilACTIVE MOIETYT5L8T28FGPSYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]2
PetrolatumACTIVE MOIETY4T6H12BN9USYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]2
LanolinINACTIVE INGREDIENT7EV65EAW6HSYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0509SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]10Current NDC, Legacy NDC, 2 package rows20241208_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 12 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
application number: M018
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
application number: M018
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
application number: M018
Preferred Plus Pharmacy Redness Relief Eye DropsTETRAHYDROZOLINE HCLKinray9ffd67c4-b5c1-d587-e053-2a95a90ae3d02025-12-30WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops Soothing ReliefCARBOXYMETHYLCELLULOSE SODIUMLEADER/Cardinal Health 110, Inc.218629d4-2704-a503-e063-6294a90a39532025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMStrategic Sourcing Services LLCfb85ebc0-1570-972b-e053-6294a90a3dc42025-12-30WarningsExact identifier
application number: M018
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
application number: M018
Equate Optimal Hydration Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart, Inc.151b9723-5d5e-ac2b-e063-6294a90af0732025-12-30WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMWalmart Inc.152171db-2f2a-9d36-e063-6394a90a72252025-12-30WarningsExact identifier
application number: M018
Equate Moisturizing Comfort Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart Inc.152028bd-0429-720a-e063-6294a90a14652025-12-30WarningsExact identifier
application number: M018
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
application number: M018
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
application number: M018
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim46854996-a0b9-46b4-e063-6294a90aa4332025-12-22WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. LTD468559a0-9586-9982-e063-6394a90af4662025-12-22WarningsExact identifier
application number: M018
Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc4682f68d-6bdd-d860-e063-6394a90a2b522025-12-21WarningsExact identifier
application number: M018
Original Redness RelieverTETRAHYDROLIZINE HCLKC Pharmaceuticals4683b850-b0fc-5093-e063-6294a90aef442025-12-21WarningsExact identifier
application number: M018
Equate Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMWalmart4449a55b-2cd4-0cb9-e063-6294a90aafbc2025-12-20WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart44494842-e38d-617c-e063-6294a90afaf82025-12-20WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
706820mineral oil 3 % / petrolatum 94 % Ophthalmic OintmentPSN4689c59c-5721-3f91-6c85-e41501998fd010
706820mineral oil 0.03 MG/MG / petrolatum 0.94 MG/MG Ophthalmic OintmentSCD4689c59c-5721-3f91-6c85-e41501998fd010
706820mineral oil 3 % / petrolatum, white 94 % Ophthalmic OintmentSY4689c59c-5721-3f91-6c85-e41501998fd010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0509-35000650509351 TUBE in 1 CARTON (0065-0509-35) / 3.5 g in 1 TUBE1 tube2008-06-260000-00-00NoNoCurrent