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

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 Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U
Rxcui706820

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 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

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