Home NDC 59316-208 Biofreeze
Product NDC 59316-208
11-digit product format 593160208
Labeler code 59316
Product ID 59316-208_522e54c1-580e-1a06-e063-6294a90a4d71
Type HUMAN OTC DRUG
Nonproprietary name Camphor, Capsaicin, Menthol
Dosage form GEL
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-24
Substance CAPSAICIN; CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM
Active strength .5; 60; 100 mg/mL; mg/mL; 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 Triple Target Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .5 mg/mL CAMPHOR (NATURAL) 60 mg/mL MENTHOL, UNSPECIFIED FORM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S07O44R1ZM Internal UNII lookup N20HL7Q941 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2741687 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 59316-208-33 BiofreezeTriple Target Roll-On 74 mL in 1 BOTTLE GEL 74 2 59316-208-33 BiofreezeTriple Target Roll-On 1 in 1 CARTON GEL 1 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-208-33 59316020833 1 BOTTLE in 1 CARTON (59316-208-33) / 74 mL in 1 BOTTLE 1 bottle 2026-04-24 No No Current