Vite20

Product NDC
63347-800
11-digit product format
633470800
Labeler code
63347
Product ID
63347-800_d6d98f0f-58dd-4fb8-9403-5ce47b071e29
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Blaine Labs Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-01
Substance
UNDECYLENIC ACID
Active strength
2 mg/20mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vite20
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID2 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-800-012022-02-21C16284748780-1d6a99b39-37f8-a426-e053-dadaa90af4c218f8ea1c-360e-43c0-98df-5816af4dec66
63347-800-012022-01-28C16284748780-1d6a99b39-37f8-a426-e053-dadaa90af4c218f8ea1c-360e-43c0-98df-5816af4dec66

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-800-01Vite2020 mL in 1 TUBECREAM205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24NVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24NVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
CLOTRIMAZOLEINACTIVE INGREDIENTG07GZ97H65VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
COCO-CAPRYLATEINACTIVE INGREDIENT4828G836N6VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)INACTIVE INGREDIENTX70SE62ZARVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
UREAINACTIVE INGREDIENT8W8T17847WVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RVITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-800VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]5Current NDC, Legacy NDC, 1 package rows20241226_18f8ea1c-360e-43c0-98df-5816af4dec66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-800-016334708000120 mL in 1 TUBE (63347-800-01) 20 ml2012-02-010000-00-00NoNoCurrent