Novana All-In-One One Step Perineal

Product NDC
76077-500
11-digit product format
760770500
Labeler code
76077
Product ID
76077-500_c0b20660-4e87-4171-9c70-b6192b224f2c
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
NOVANA MEDICAL LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-04
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
0 mL/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76077-500-082019-11-13C16284748780-197449f38-cb54-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76077-500-08Novana All-In-One One Step Perineal240 mL in 1 BOTTLE, SPRAYLOTION2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76077-500-08ML - Milliliter76077-500220881c4-e0da-42a8-9d54-26dba6642d4b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1ONOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
DimethiconeACTIVE MOIETY92RU3N3Y1ONOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
AllantoinINACTIVE INGREDIENT344S277G0ZNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Iodopropynyl ButylcarbamateINACTIVE INGREDIENT603P14DHEBNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
PanthenolINACTIVE INGREDIENTWV9CM0O67ZNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
PropanediolINACTIVE INGREDIENT5965N8W85TNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP0NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Soybean OilINACTIVE INGREDIENT241ATL177ANOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
TocopherolINACTIVE INGREDIENTR0ZB2556P8NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RNOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76077-500NOVANA ALL-IN-ONE ONE STEP PERINEAL (DIMETHICONE) LOTION [NOVANA MEDICAL LLC]3Legacy NDC, 1 package rows20120411_8369a529-5e7c-45af-ab9a-362b8a16f57d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198605dimethicone 2 % Topical LotionPSN8369a529-5e7c-45af-ab9a-362b8a16f57d3
198605dimethicone 20 MG/ML Topical LotionSCD8369a529-5e7c-45af-ab9a-362b8a16f57d3
198605dimethicone 2 % Topical LotionSY8369a529-5e7c-45af-ab9a-362b8a16f57d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76077-500-0876077050008240 mL in 1 BOTTLE, SPRAY240 mlHistorical