Home NDC 63347-800 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 63347-800 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63347-800 63347-800-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…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 Ingredient Strength UNDECYLENIC ACID 2 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63347-800-01 Vite20 20 mL in 1 TUBE CREAM 20 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63347-800 VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241226_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 8 of 51 · 1,004 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63347-800-01 63347080001 20 mL in 1 TUBE (63347-800-01) 20 ml 2012-02-01 0000-00-00 No No Current