Home NDC 72235-5838 Lubracane
Product NDC 72235-5838
11-digit product format 722355838
Labeler code 72235
Product ID 72235-5838_a0727e5c-e1ae-4e4c-a757-25e3c5f83a89
Type HUMAN OTC DRUG
Nonproprietary name Lubracane
Dosage form GEL
Route TOPICAL
Labeler Ozeion LLC
Application M341
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-15
Substance MENTHOL
Active strength .24 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Lubracane
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .24 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72235-5838-1 Lubracane 118.3 mL in 1 JAR GEL 118.3 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72235-5838 LUBRACANE GEL [OZEION LLC] 8 Current NDC, Legacy NDC, 1 package rows 20250101_7c503e3e-1987-4027-8a43-12acf2cb548a.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 1 of 1 · 1 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 72235-5838-1 72235583801 118.3 mL in 1 JAR (72235-5838-1) 118.3 ml 2018-01-15 0000-00-00 No No Current