NDC 76077-500

Novana All-In-One One Step Perineal

Dimethicone

Novana All-In-One One Step Perineal is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Novana Medical Llc. The primary component is Dimethicone.

Product ID76077-500_c0b20660-4e87-4171-9c70-b6192b224f2c
NDC76077-500
Product TypeHuman Otc Drug
Proprietary NameNovana All-In-One One Step Perineal
Generic NameDimethicone
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2012-04-04
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameNOVANA MEDICAL LLC
Substance NameDIMETHICONE
Active Ingredient Strength0 mL/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76077-500-08

240 mL in 1 BOTTLE, SPRAY (76077-500-08)
Marketing Start Date2012-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76077-500-08 [76077050008]

Novana All-In-One One Step Perineal LOTION
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-04-04
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE.02 mL/mL

OpenFDA Data

SPL SET ID:8369a529-5e7c-45af-ab9a-362b8a16f57d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198605
  • NDC Crossover Matching brand name "Novana All-In-One One Step Perineal" or generic name "Dimethicone"

    NDCBrand NameGeneric Name
    76077-500Novana All-In-One One Step PerinealNovana All-In-One One Step Perineal
    0132-0326Boudreauxs Butt BarrierDimethicone
    0187-2218CeraVeDimethicone
    0187-2219CeraVedimethicone
    0187-2489CeraVedimethicone
    0299-4114Cetaphil Cracked Skin RepairDimethicone
    0299-4115Cetaphil Cracked Skin Repair BalmDimethicone
    0573-1935CHAPSTICK OVERNIGHTdimethicone
    0363-2247Daily BabyDimethicone
    0869-0354Daily BabyDimethicone
    0869-0496Daily BabyDimethicone
    0869-0619Daily MoisturizingDimethicone
    0363-5345Infants Gas ReliefDimethicone
    0363-5773Infants Gas ReliefDIMETHICONE
    0259-2202Mederma PMDimethicone
    0259-2102Mederma Stretch Marks Therapydimethicone
    0093-3204MoisturelDimethicone
    0430-3100MoisturelDimethicone
    10742-7005Softlipsdimethicone
    10742-7002Softlips Cherry, Raspberry, Vanilladimethicone
    10742-7003Softlips Watermelon, Tropical Coconut, Peach Passiondimethicone
    0132-8744Summers Eve Active ChafeDimethicone
    0187-1660TheraSealDimethicone

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