Lubracane

Product NDC: 72235-5838
Requested package NDC: 72235-5838-1
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7c503e3e-1987-4027-8a43-12acf2cb548a	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubracane	LUBRACANE	Ozeion LLC	7c503e3e-1987-4027-8a43-12acf2cb548a	2026-01-10	Warnings	Exact identifier application number: M341 ndc (package): 72235-5838-1 ndc (product): 72235-5838 ndc11 (package): 72235583801

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