Home NDC 59316-833 Biofreeze
Product NDC 59316-833
11-digit product format 593160833
Labeler code 59316
Product ID 59316-833_51b57ded-2d7c-d540-e063-6394a90a4744
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form SPRAY
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance MENTHOL
Active strength 105 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 Biofreeze
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 105 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1489073 Internal RxNorm lookup 1489074 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-833-10 Biofreeze 89 mL in 1 BOTTLE SPRAY 89 12 59316-833-20 Biofreeze 118 mL in 1 BOTTLE SPRAY 118 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-833 BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC] 10 Current NDC, 2 package rows 20240202_00bb462a-27d0-6f74-e063-6394a90a90ec.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-833-10 59316083310 89 mL in 1 BOTTLE (59316-833-10) 89 ml 2023-12-01 No No Current 59316-833-20 59316083320 118 mL in 1 BOTTLE (59316-833-20) 118 ml 2026-01-01 No No Current