Home NDC 63347-601 TERPENICOL
Product NDC 63347-601
11-digit product format 633470601
Labeler code 63347
Product ID 63347-601_f6a16024-2fa1-44ff-a718-af2dc7ae822e
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 2017-06-19
Substance UNDECYLENIC ACID
Active strength 4.55 g/37.5mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 TERPENICOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 4.55 g/37.5mL
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 63347-601-01 TERPENICOL 37.5 mL in 1 BOTTLE CREAM 37.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63347-601 TERPENICOL (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231222_efd99ed1-07d3-4862-ae47-883f7d1c91c6.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 49 · 973 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 63347-601-01 63347060101 37.5 mL in 1 BOTTLE (63347-601-01) 37.5 ml 2017-06-19 0000-00-00 No No Current