Novana Protect Barrier

Product NDC
76077-300
11-digit product format
760770300
Labeler code
76077
Product ID
76077-300_7dfb8b9c-ad7a-4ba9-bbc9-3e356fd002ae
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
NOVANA MEDICAL LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-04-04
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
0 mL/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76077-300-042019-11-13C16284748780-197449f38-cb78-f6ea-e053-dbdaa90aa703Drug Facts
76077-300-072019-11-13C16284748780-197449f38-cb78-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76077-300-04Novana Protect Barrier120 mL in 1 TUBECREAM1203
76077-300-07Novana Protect Barrier210 mL in 1 TUBECREAM2103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76077-300-04GM - Gram76077-300c49b1c8e-aa4b-4281-91bb-e84c4c2014ac12013-02-13
76077-300-07GM - Gram76077-300359a6b66-885b-4414-a6ba-dcf503317a9912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Zinc OxideACTIVE MOIETYSOI2LOH54ZNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Cod Liver OilINACTIVE INGREDIENTBBL281NWFGNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
DimethiconeINACTIVE INGREDIENT92RU3N3Y1ONOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
LanolinINACTIVE INGREDIENT7EV65EAW6HNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
PetrolatumINACTIVE INGREDIENT4T6H12BN9UNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
PropanediolINACTIVE INGREDIENT5965N8W85TNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP0NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RNOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76077-300NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]3Legacy NDC, 2 package rows20120426_c857326a-655c-428d-ab96-a2da492194e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417994zinc oxide 12 % Topical CreamPSNc857326a-655c-428d-ab96-a2da492194e63
417994zinc oxide 120 MG/ML Topical CreamSCDc857326a-655c-428d-ab96-a2da492194e63
417994zinc oxide 12 % Topical CreamSYc857326a-655c-428d-ab96-a2da492194e63
417994ZNO 120 MG/ML Topical CreamSYc857326a-655c-428d-ab96-a2da492194e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76077-300-0476077030004120 mL in 1 TUBE120 mlHistorical
76077-300-0776077030007210 mL in 1 TUBE210 mlHistorical