Home NDC 59316-835 Biofreeze
Product NDC 59316-835
11-digit product format 593160835
Labeler code 59316
Product ID 59316-835_56453b7f-c5e1-141f-e063-6394a90a629e
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 2026-01-20
Substance MENTHOL
Active strength 130 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
Brand name suffix Professional
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 130 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 2732274 Internal RxNorm lookup 2732276 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 59316-835-20 BiofreezeProfessional 118 mL in 1 BOTTLE SPRAY 118 13
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 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-835-20 59316083520 118 mL in 1 BOTTLE (59316-835-20) 118 ml 2026-01-20 No No Current 59316-835-22 59316083522 2 BOTTLE in 1 CARTON (59316-835-22) / 118 mL in 1 BOTTLE 2 bottle 2026-01-20 No No Current