FDA.reportPublic FDA data

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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct63347-800EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63347-80063347-800-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18f8ea1c-360e-43c0-98df-5816af4dec66Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
application number: M005
Toenail Fungus Treatment Extra Strength PenTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fbcc50-a3ac-d6d1-e063-6294a90aa2b62026-04-02WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
application number: M005
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
application number: M005
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDEHanyang Qisheng (Shenzhen) Technology Co., Ltd.4e85f338-ffd7-85b1-e063-6294a90a3c872026-04-02WarningsExact identifier
application number: M005
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsExact identifier
application number: M005
Fungicure Anti-Fungal LiquidTOLNAFTATEKobayashi Healthcare International, Inc.b18ee199-0659-733c-e053-2a95a90ab6b52026-04-01WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYCVS Pharmacy96cc594d-85c8-4f62-bc0a-3176c8739f212026-04-01WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYCVS Pharmacya7b6bd7c-23db-43e1-92f7-e27f5f4801de2026-04-01WarningsExact identifier
application number: M005
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
application number: M005
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
application number: M005
Critic Aid Clear AFMICONAZOLE NITRATEColoplast Corpcbc5d976-850a-476e-b179-b7a5a86755242026-03-31WarningsExact identifier
application number: M005

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