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 93 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DermaRad Relief LIDOCAINE EMULSION RENU LABORATORIES, LLC d5e11f73-918b-eeac-e053-2995a90a4a83 2025-05-06 Warnings Exact identifier application number: M017 Plantar Fasciitis Pain Relief Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 34838622-b092-afeb-e063-6294a90ae7db 2025-05-06 Warnings Exact identifier application number: M017 Climax Shield Delay BENZOCAINE PRODUCT MAX GROUP INC 9c720cdc-f753-47ce-95ff-3b26e461a0ab 2025-05-05 Warnings Exact identifier application number: M017 PediFix Lidocaine Pain-Relief Patches LIDOCAINE PAIN-RELIEF PATCHES PediFix, Inc 346550b9-d2ba-184e-e063-6394a90a591a 2025-05-05 Warnings Exact identifier application number: M017 Walgreens Stop Itch Gel DIPHENHYDRAMINE HCL Walgreens Co 23586336-8f46-3dcd-e063-6394a90accc9 2025-05-04 Warnings Exact identifier application number: M017 WaxRx EarAcheRx Pain Relieving Drops 4% LIDOCAINE HCL DOCTOR EASY MEDICAL PRODUCTS, LLC 34156655-8706-f0a4-e063-6294a90acc90 2025-05-01 Warnings Exact identifier application number: M017 foster and thrive anti itch cream DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Strategic Sourcing Services LLC bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 2025-04-30 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Solis Pharmaceuticals Inc. 3061d301-2104-b1b2-e063-6394a90a9b6e 2025-04-29 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 33ed754e-8852-d5b2-e063-6394a90a7cf2 2025-04-29 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL InterMed Laboratories Private Limited 33ee6e48-243e-4ded-e063-6394a90a987d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 32b96689-8e9b-4c2e-e063-6294a90a7d1c 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Exact identifier application number: M017 Ivarest Poison Ivy Removal and Itch Relief PRAMOXINE HYDROCHLORIDE Blistex Inc. dedbf5d9-0f86-4f32-8321-da86c9838c0a 2025-04-29 Warnings Exact identifier application number: M017 HealthWise 2X Medicated Pain Relief Cream Roll-on MENTHOL Veridian Healthcare 33dae8a8-4197-f276-e063-6294a90aea83 2025-04-28 Warnings Exact identifier application number: M017 HealthWise Roll-on Menthol Pain Relief Gel MENTHOL Veridian Healthcare 33dbb939-9397-7e70-e063-6294a90ac8f4 2025-04-28 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. fa1a98bc-c233-410d-a20e-71111c897372 2025-04-28 Warnings Exact identifier application number: M017 Lidocaine Patch 4% LIDOCAINE 4% Medcore LLC b961906c-fe66-466b-af2c-072781fa098b 2025-04-28 Warnings Exact identifier application number: M017 Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 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