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 4 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
application number: M018
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
application number: M018
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
application number: M018
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
application number: M018
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
application number: M018
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
application number: M018
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
application number: M018
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
application number: M018
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
application number: M018
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
application number: M018
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
application number: M018
NOVEHA NIGHTTIMEWHITE PETROLATUMBullet Point LLC4da24578-e98b-8ce1-e063-6294a90a8bf62026-03-24WarningsExact identifier
application number: M018
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
application number: M018
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
application number: M018
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact 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