Home NDC 59316-116 Biofreeze Professional Colorless
Product NDC 59316-116
11-digit product format 593160116
Labeler code 59316
Product ID 59316-116_51991b66-c6a4-c6d4-e063-6394a90a6f71
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form GEL
Route TOPICAL
Labeler Reckitt Benckiser
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-06-03
Substance MENTHOL, UNSPECIFIED FORM
Active strength 50 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Professional Colorless
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 50 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 415975 Internal RxNorm lookup 1794892 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 59316-116-10 Biofreeze Professional Colorless 89 mL in 1 BOTTLE GEL 89 13 59316-116-11 Biofreeze Professional Colorless 3 mL in 1 PACKET GEL 3 13 59316-116-20 Biofreeze Professional Colorless 118 mL in 1 TUBE GEL 118 13 59316-116-40 Biofreeze Professional Colorless 946 mL in 1 BOTTLE GEL 946 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-116 BIOFREEZE PROFESSIONAL COLORLESS (MENTHOL, UNSPECIFIED FORM) GEL [RB HEALTH (US) LLC] 12 Current NDC, Legacy NDC, 4 package rows 20241228_4639201c-a67a-475f-8df6-3dc6225803ad.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 45 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LUBRICAINE LIDOCAINE 4% ESBA LABORATORIES INC. 9d7416b1-607d-34e0-e053-2a95a90aa3c3 2026-01-08 Warnings Exact identifier application number: M017 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC 0a1aeff0-bade-457b-a0ac-099d646c0b2e 2026-01-08 Warnings Exact identifier application number: M017 4% MENTHOL COLD THERAPY MENTHOL Universal Distribution Center LLC 66892993-a755-4584-b2a8-2e8d7ac70593 2026-01-08 Warnings Exact identifier application number: M017 Private Label Antifungal Barrier Cream 2% MICONAZOLE NITRATE CREAM Swiss-American CDMO, LLC e74bddea-c1ac-4e4e-84bd-5a9defb85b2d 2026-01-08 Warnings Exact identifier application number: M017 2.0% LIDOCAINE BURN LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC e1911279-85f7-4053-b6da-8f4e991347a2 2026-01-08 Warnings Exact identifier application number: M017 POMG PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE, MENTHOL POMG LLC 1fa980fb-fc0e-fdd0-e063-6394a90adc13 2026-01-07 Warnings Exact identifier application number: M017 Artridon Glucosamine MENTHOL, METHYL SALICYLATE Pharmadel LLC 73572156-4cce-0669-e053-2991aa0aaecc 2026-01-07 Warnings Exact identifier application number: M017 HealthWise Cooling Pain Relief MENTHOL Veridian Healthcare 6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd 2026-01-07 Warnings Exact identifier application number: M017 Hydrocortisone 1% Anti-Itch Cream HYDROCORTISONE DLC Laboratories, Inc. 16eeec2c-065d-4da0-e063-6294a90a3873 2026-01-07 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone HYDROCORTISONE DLC Laboratories, Inc caf50f12-f35c-4e9e-8ef7-3b0c84e225ee 2026-01-07 Warnings Exact identifier application number: M017 EARTHS CARE MUSCLE AND JOINT RUB CAMPHOR DLC Laboratories, Inc. 71e33e06-4dc3-4ead-a122-ff89d93a64de 2026-01-07 Warnings Exact identifier application number: M017 Amour CBD PAIN RELIEF CREAM SVD Premium Products 95b45e79-b1e7-17b2-e053-2995a90a8836 2026-01-07 Warnings Exact identifier application number: M017 Tiger Balm Active Muscle METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM Haw Par Healthcare Ltd. 845a4ead-f9c0-4009-bcae-b17cd388439b 2026-01-07 Warnings Exact identifier application number: M017 3X Medicated Toothache and Gum Gel BENZOCAINE Rite Aid 996f7989-17ce-5b28-e053-2995a90af8b8 2026-01-06 Warnings Exact identifier application number: M017 QNTAMAX Muscle and Joint Pain Relieving CAMPHOR (SYNTHETIC), MENTHOL Qntamax LLC 6622b94c-824e-4e84-a8d8-b60bb0b866e2 2026-01-06 Warnings Exact identifier application number: M017 Winco Muscle and Joint Pain Relief Gel 2oz WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF WINCO FOODS, LLC 47bedf4e-4036-cf43-e063-6394a90a91d6 2026-01-06 Warnings Exact identifier application number: M017 Pain Relief Hot Patch MENTHOL AND CAPSAICIN Universal Distribution Center LLC 110bcb16-ef0b-4bc8-8877-173a0494e1ad 2026-01-06 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4582b4e9-0c24-069d-e063-6394a90a6f4b 2026-01-05 Warnings Exact identifier application number: M017 Lidocaine 4% Topical Anesthetic Cream LIDOCAINE 4% Oncor Pharmaceuticals 1baaa669-05af-4024-a0ba-ee3451756f6a 2026-01-05 Warnings Exact identifier application number: M017 TheraCare Pain Relief MENTHOL Veridian Healthcare 6834a6de-4d1d-4e40-945d-ec5c267abd14 2026-01-05 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 59316-116-10 59316011610 89 mL in 1 BOTTLE (59316-116-10) 89 ml 2026-05-14 No No Current 59316-116-11 59316011611 3 mL in 1 PACKET 3 ml Historical 59316-116-20 59316011620 118 mL in 1 TUBE (59316-116-20) 118 ml 2016-06-03 0000-00-00 No No Current 59316-116-40 59316011640 946 mL in 1 BOTTLE (59316-116-40) 946 ml 2016-06-03 0000-00-00 No No Current