Home NDC 59316-103 Biofreeze Colorless
Product NDC 59316-103
11-digit product format 593160103
Labeler code 59316
Product ID 59316-103_51b597cc-8068-e160-e063-6394a90ac1be
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-01-03
Substance MENTHOL, UNSPECIFIED FORM
Active strength 40 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Colorless
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 40 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 415974 Internal RxNorm lookup 1111683 Internal RxNorm 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 59316-103-10 Biofreeze Colorless 5 mL in 1 BOTTLE GEL 5 31 59316-103-11 Biofreeze Colorless 3 mL in 1 BOTTLE GEL 3 31 59316-103-12 Biofreeze Colorless 89 mL in 1 BOTTLE GEL 89 31 59316-103-15 Biofreeze Colorless 89 mL in 1 BOTTLE, WITH APPLICATOR GEL 89 31 59316-103-20 Biofreeze Colorless 118 mL in 1 BOTTLE GEL 118 31 59316-103-28 Biofreeze Colorless 273 mL in 1 BOTTLE GEL 273 31 59316-103-40 Biofreeze Colorless 946 mL in 1 BOTTLE GEL 946 31
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-103 BIOFREEZE COLORLESS (MENTHOL) GEL [RB HEALTH (US) LLC] 30 Current NDC, Legacy NDC, 7 package rows 20241228_939dbbc3-71ec-4990-840e-7c9b8d430562.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 26 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sabharwals LIDOCAINE 4% GEL PATCH Dr. Sabharwal's Wound Care 102399b6-5be9-ee5e-e063-6394a90a3198 2026-04-02 Warnings Exact identifier application number: M017 TATTOO NUMBX NUMBING PAIN RELIEVING LIDOCAINE HYDROCHLORIDE Scyberco Ltd ac8eac04-ed5b-4c8e-9f9b-54d160b74606 2026-04-02 Warnings Exact identifier application number: M017 FifthPulse Hydrocortisone HYDROCORTISONE WeCare Products LLC f1fcb045-4a15-431b-9617-67eae9f87fbd 2026-04-02 Warnings Exact identifier application number: M017 ANIXIKE Cream MENTHOL 5% CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 4e8510e6-c0c7-bf6b-e063-6294a90a3b00 2026-04-02 Warnings Exact identifier application number: M017 RAPID RELIEF 0.025% CAPSAICIN PAIN PATCH 83569 4ed549e8-0062-fb03-e063-6294a90aac65 2026-04-02 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL AND ZINC ACETATE CVS Pharmacy 7e921988-ec66-38dc-e053-2a91aa0a7346 2026-04-01 Warnings Exact identifier application number: M017 The Best Numbing Cream TBNC The Best Numbing Cream LLC 4ca3923b-f586-0aaf-e063-6294a90a16c1 2026-03-31 Warnings Exact identifier application number: M017 ChapStick Classic Medicated EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42798a6c-2d7e-80f6-e063-6294a90a105f 2026-03-31 Warnings Exact identifier application number: M017 Roll-On Pain Relief Liquid LIDOCAINE HCL HyVee Inc 4da6f6fb-b182-360f-e063-6294a90abdf3 2026-03-31 Warnings Exact identifier application number: M017 Hand Sanitizer ALCOHOL ProStat First Aid 4e54aecb-190f-3866-e063-6294a90a810a 2026-03-31 Warnings Exact identifier application number: M017 Burn Mist LIDOCAINE HYDROCHLORIDE Water-Jel Technologies c53ab9dd-351a-400b-b873-4f396e0af54d 2026-03-31 Warnings Exact identifier application number: M017 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Exact identifier application number: M017 ZENOL COOL METHYL SALICYLATE, L-MENTHOL BA TRADE INC 4e5c45f4-88ce-3a13-e063-6394a90a2a09 2026-03-31 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 091451fb-e30a-0012-e063-6394a90a3ba8 2026-03-31 Warnings Exact identifier application number: M017 Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint MENTHOL Chattem, Inc. b16ba9c2-23bf-4fdf-b44b-7abb9fec1911 2026-03-31 Warnings Exact identifier application number: M017 DR.PABU NUMBING LIDOCAINE 5% NUMBING Jiangxi Yudexi Pharmaceutical Co., LTD 4e3a3c6c-4821-76ea-e063-6294a90a8f96 2026-03-30 Warnings Exact identifier application number: M017 Doctor Jiao Antifungal Cream MICONAZOLE NITRATE Jiangxi Haiwei Pharmaceutical Co., Ltd. 4e3b231e-0642-bf63-e063-6394a90a905b 2026-03-30 Warnings Exact identifier application number: M017 CVS Muscle Balm and Roll-On CAMPHOR, MENTHOL CVS Pharmacy 4e40025a-070a-508e-e063-6394a90af5d7 2026-03-30 Warnings Exact identifier application number: M017 REGENECARE HA LIDOCAINE HCL MPM Medical LLC c3eec066-38e8-4617-b34d-2f72ffb7a324 2026-03-30 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Matcha Honey CAMPHOR, MENTHOL The Mentholatum Company 4e03a721-73f3-b2f2-e063-6394a90a44e6 2026-03-27 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59316-103-10 59316010310 5 mL in 1 BOTTLE 5 ml Historical 59316-103-11 59316010311 3 mL in 1 BOTTLE (59316-103-11) 3 ml 2012-01-03 2021-12-31 No No Current 59316-103-12 59316010312 89 mL in 1 BOTTLE (59316-103-12) 89 ml 2016-09-19 0000-00-00 No No Current 59316-103-15 59316010315 89 mL in 1 BOTTLE, WITH APPLICATOR 89 ml Historical 59316-103-20 59316010320 118 mL in 1 BOTTLE (59316-103-20) 118 ml 2012-01-03 0000-00-00 No No Current 59316-103-28 59316010328 273 mL in 1 BOTTLE 273 ml Historical 59316-103-40 59316010340 946 mL in 1 BOTTLE (59316-103-40) 946 ml 2012-01-03 0000-00-00 No No Current