Home NDC 59316-230 BioFreeze Dry Stick
Product NDC 59316-230
11-digit product format 593160230
Labeler code 59316
Product ID 59316-230_51b58d0f-b967-1b22-e063-6294a90ac892
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form STICK
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-28
Substance MENTHOL
Active strength .15 g/g
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 BioFreeze Dry Stick
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .15 g/g
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 59316-230-23 BioFreeze Dry Stick 22 g in 1 TUBE STICK 22 2 59316-230-23 BioFreeze Dry Stick 1 in 1 CARTON STICK 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-230 BIOFREEZE DRY STICK (MENTHOL) STICK [RB HEALTH (US) LLC] 1 Current NDC, 2 package rows 20241228_26d62cd2-9209-8cca-e063-6394a90a2028.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 18 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-230-23 59316023023 1 TUBE in 1 CARTON (59316-230-23) / 22 g in 1 TUBE 1 tube 2024-12-28 No No Current