NDC 0065-0509

Systane Nighttime

Mineral Oil And White Petrolatum

Systane Nighttime is a Ophthalmic Ointment in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Mineral Oil; Petrolatum.

Product ID0065-0509_208c2259-74d5-4380-8b9c-29b3ead26fa5
NDC0065-0509
Product TypeHuman Otc Drug
Proprietary NameSystane Nighttime
Generic NameMineral Oil And White Petrolatum
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date2008-06-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAlcon Laboratories, Inc.
Substance NameMINERAL OIL; PETROLATUM
Active Ingredient Strength30 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0065-0509-35

1 TUBE in 1 CARTON (0065-0509-35) > 3.5 g in 1 TUBE
Marketing Start Date2008-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0509-35 [00065050935]

Systane Nighttime OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2008-06-26

Drug Details

Active Ingredients

IngredientStrength
MINERAL OIL30 mg/g

OpenFDA Data

SPL SET ID:4689c59c-5721-3f91-6c85-e41501998fd0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827713
  • 706820
    • UPC Code
  • 0300650509350

    • NDC Crossover Matching brand name "Systane Nighttime" or generic name "Mineral Oil And White Petrolatum"

    NDCBrand NameGeneric Name
    0065-0509Systane Nighttimemineral oil and white petrolatum
    17312-403Com-Pare2 Nighttime Eyemineral oil and white petrolatum
    0904-6488Major LubriFresh PMMineral oil and White petrolatum
    68788-6987Major LubriFresh PMMineral oil and White petrolatum
    0536-1086Rugby Artificial TearsMineral oil and White petrolatum
    0363-6855Walgreens PM Lubricant Eyemineral oil and white petrolatum
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