Home NDC 59316-102 BIOFREEZE
Product NDC 59316-102
11-digit product format 593160102
Labeler code 59316
Product ID 59316-102_51b44481-a7ad-8a46-e063-6294a90aefda
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 · 36 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
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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-102 BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC] 34 Current NDC, Legacy NDC, 16 package rows 20231114_83d5c2f2-2413-4d28-83b2-0808d0917b4d.zip 59316-102 BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.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 99 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VTROUY Tattoo Numbing Cream TATTOO NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 2e899851-b3cd-0758-e063-6294a90afea8 2025-02-19 Warnings Exact identifier application number: M017 Pomada Dragon Pain Relief MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE Genomma Lab USA 9d98f48b-6d88-4df9-9459-7cf7ba5de044 2025-02-19 Warnings Exact identifier application number: M017 Pain Relieving Cream HISTAMINE DIHYDROCHLORIDE Mediapower, Inc. DBA Dr Newton's And Naturals 9eeea033-ae87-4d83-85d0-b8fa653a0806 2025-02-19 Warnings Exact identifier application number: M017 Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular ALUMINUM CHLOROHYDRATE Sodalis USA, LLC 7839cf53-dbd2-4dbb-a309-1581d51f8adc 2025-02-18 Warnings Exact identifier application number: M017 CANNA NUMB Roll On LIDOCAINE HYDROCHLORIDE, MENTHOL Cannanumb LLC c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4 2025-02-17 Warnings Exact identifier application number: M017 Vaporizing Chest Rub 4 oz. CAMPHOR, EUCALYPTUS OIL, MENTHOL Rejoice International Inc. 7173b141-123e-6cd4-e053-2a95a90a8600 2025-02-12 Warnings Exact identifier application number: M017 Vaporizing Chest Rub 4 oz. 3 pk CAMPHOR, EUCALYPTUS OIL, MENTHOL Rejoice International Inc. 71c186a1-8283-2482-e053-2995a90acc1f 2025-02-12 Warnings Exact identifier application number: M017 Roman Swipes BENZOCAINE Roman Health Ventures Inc. 7f0eac8c-7235-99d8-e053-2a91aa0a634e 2025-02-12 Warnings Exact identifier application number: M017 SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR EVI LABS EVI LABS 2df7658d-83d3-41ac-e063-6294a90ab1dd 2025-02-12 Warnings Exact identifier application number: M017 Signature Care Medicated Pain Relief Patch LIDOCAINE Safeway, Inc. 2165a342-5f8b-78e0-e063-6394a90a06c4 2025-02-12 Warnings Exact identifier application number: M017 CheeZheng Pain Relieveing Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd. abcebdf1-9037-4094-93e1-ce8f20b18ea7 2025-02-11 Warnings Exact identifier application number: M017 Tibetree Pain Relieveing Medicated Plaster CAMPHOR Tibet Cheezheng Tibetan Medicine Co. Ltd 4216bd48-5c62-4e87-adcc-67bf7152d64d 2025-02-11 Warnings Exact identifier application number: M017 AsperFlex LIDOCAINE Akron Pharma Inc. ab50525e-b534-452b-8c25-2992c0cbf862 2025-02-10 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Olakino Therapeutics LLC 2a41a621-c6f7-5819-e063-6394a90ae67d 2025-02-07 Warnings Exact identifier application number: M017 Pain Reliveing Patch LIDOCAINE 4% simple diagnostics 02ed0b27-bba9-ec0c-e063-6294a90a014d 2025-02-07 Warnings Exact identifier application number: M017 FlexDermal Pain Relieving Roll-On MENTHOL SOLVADERM LLC d4d8050e-0761-4491-8635-39c806701eb5 2025-02-06 Warnings Exact identifier application number: M017 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE Clarion Brands LLC 2d7e9f6a-0f21-b103-e063-6294a90a912f 2025-02-06 Warnings Exact identifier application number: M017 signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 2d685602-5cd6-3b36-e063-6394a90a3c5d 2025-02-05 Warnings Exact identifier application number: M017 Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 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 59316-102-10 59316010210 5 mL in 1 BOTTLE (59316-102-10) 5 ml 2012-01-03 0000-00-00 No No Current 59316-102-11 59316010211 3 mL in 1 BOTTLE (59316-102-11) 3 ml 2012-01-03 0000-00-00 No No Current 59316-102-12 59316010212 89 mL in 1 BOTTLE (59316-102-12) 89 ml 2016-09-19 0000-00-00 No No Current 59316-102-15 59316010215 89 mL in 1 BOTTLE, WITH APPLICATOR 89 ml Historical 59316-102-16 59316010216 89 mL in 1 BOTTLE, WITH APPLICATOR 89 ml Historical 59316-102-20 59316010220 118 mL in 1 BOTTLE (59316-102-20) 118 ml 2012-01-03 0000-00-00 No No Current 59316-102-25 59316010225 118 mL in 1 BOTTLE, WITH APPLICATOR (59316-102-25) 118 ml 2012-01-03 2021-12-31 No No Current 59316-102-28 59316010228 237 mL in 1 BOTTLE (59316-102-28) 237 ml 2016-09-19 0000-00-00 No No Current 59316-102-30 59316010230 473 mL in 1 BOTTLE (59316-102-30) 473 ml 2012-01-03 0000-00-00 No No Current 59316-102-40 59316010240 946 mL in 1 BOTTLE (59316-102-40) 946 ml 2012-01-03 0000-00-00 No No Current 59316-102-50 59316010250 3785 mL in 1 CONTAINER (59316-102-50) 3785 ml 2012-01-03 0000-00-00 No No Current 59316-102-80 59316010280 44 mL in 1 TUBE (59316-102-80) 44 ml 2018-11-02 0000-00-00 No No Current 59316-102-90 59316010290 100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10) 100 bottle 2012-01-03 0000-00-00 No No Current 59316-102-91 59316010291 10 BOTTLE in 1 CARTON (59316-102-91) > 3 mL in 1 BOTTLE (59316-102-11) 10 bottle 2012-01-03 0000-00-00 No No Current 59316-102-92 59316010292 16 BOTTLE in 1 CARTON (59316-102-92) > 3 mL in 1 BOTTLE (59316-102-11) 16 bottle 2012-01-03 0000-00-00 No No Current 59316-102-98 59316010298 30 mL in 1 BOTTLE (59316-102-98) 30 ml 2012-01-03 0000-00-00 No No Current