Home NDC 59316-101 Biofreeze
Product NDC 59316-101
11-digit product format 593160101
Labeler code 59316
Product ID 59316-101_51b434c9-228b-2c05-e063-6394a90a1e94
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 2016-08-25
Substance MENTHOL, UNSPECIFIED FORM
Active strength 35 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 35 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 808955 Internal RxNorm lookup 1043451 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 59316-101 BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC] 42 Current NDC, Legacy NDC, 12 package rows 20241228_684faf63-5e44-4471-8384-e8fa7c0d842a.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 145 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMS MAX FREEZE PRO FORMULA MENTHOL, UNSPECIFIED FORM KOBAYASHI Healthcare International, Inc. 436e8578-b609-4b45-8f84-0d111140fda6 2023-11-16 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE PRO FORMULA MENTHOL KOBAYASHI Healthcare International, Inc. 08dcfa78-7332-4f19-90d7-fdd7d446848a 2023-11-16 Warnings Exact identifier application number: M017 Totally Fun After Sun LIDOCAINE HCL MJ Products Association, LLC 965a2a29-914c-4ad0-b25f-5df3c30da393 2023-11-15 Warnings Exact identifier application number: M017 Universal Ice Cold Analgesic MENTHOL Universal Distribution Center LLC 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f 2023-11-15 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE PRO FORMULA MENTHOL, UNSPECIFIED FORM KOBAYASHI Healthcare International, Inc. b44beac3-1d20-434f-9a79-4fab1ac68791 2023-11-15 Warnings Exact identifier application number: M017 Universal Ice Cold Analgesic MENTHOL Universal Distribution Center LLC 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 2023-11-15 Warnings Exact identifier application number: M017 PURE EASE Joint Muscle lnstant Pain Relief CAPSAICIN, MENTHOL SERENU, INC. 42bf129c-5c84-4331-b6d0-78e3be71a985 2023-11-13 Warnings Exact identifier application number: M017 PURE EASE Neur Cream Instant Deep Pain Relief CAPSAICIN, MENTHOL SERENU, INC. e46a4636-6405-440a-a05a-862c354bab54 2023-11-13 Warnings Exact identifier application number: M017 Cryomax Cooling MENTHOL LIFE WEAR TECHNOLOGIES 0a0ae5ba-9fac-45f6-e063-6294a90ad555 2023-11-13 Warnings Exact identifier application number: M017 LBri Super Aloe Stop The Pain METHYL SALICYLATE, MENTHOL, CAPSAICIN L'Bris, Pure 'N Natural 8fb2010c-c34b-4552-858d-a0188ad313ad 2023-11-11 Warnings Exact identifier application number: M017 TOTAL RELIEF HYDROCORTISONE DR. MARDER SKINCARE, LLC 2c05459c-5a2c-45ab-b534-87f966b41681 2023-11-11 Warnings Exact identifier application number: M017 Human Science Muscle Pain Relief METHYL SALICYLATE, MENTHOL Human Science, LLC 4bccc017-264b-11ce-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Village Pharma, LLC 55108ffd-d6a8-41de-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M017 Debbies Down and Dirty Deep Tissue Joint and Muscle MENTHOL DD&D Manufacturing Co., Ltd 531fe834-53e3-305f-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M017 TerraFreeze Pain Relief MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE Beyond Derma, LLC 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677 2023-11-11 Warnings Exact identifier application number: M017 GOLD ICE Pain Relief MENTHOL Eden's Answers, Inc. a1356c39-42b9-4bd8-a873-bcd40717058b 2023-11-11 Warnings Exact identifier application number: M017 RUBBING DOTS NATURAL COOL PAIN RELIEF MENTHOL Awesome Trading, LLC 137a88ff-e409-4a67-addc-883194c356ae 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE Lidocaine Hemp Oil Topical Analgesic LIDOCAINE HYDROCHLORIDE Prime Commerce, LLC 28ed2149-38d2-4062-8442-990a98a69cfc 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE PAIN RELIEVING ROLL-ON LIDOCAINE HYDROCHLORIDE, MENTHOL Prime Commerce, LLC c263d5f2-89b9-4dfd-91c8-f894e5f956c9 2023-11-11 Warnings Exact identifier application number: M017 SUGAR BRANDS Rescue Pain Relief and Recovery LIDOCAINE HYDROCHLORIDE Sugar Brands, LLC 74013709-d1d5-4425-825d-eee726718c61 2023-11-11 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 59316-101-10 59316010110 5 mL in 1 PACKET (59316-101-10) 5 ml 2016-08-25 0000-00-00 No No Current 59316-101-11 59316010111 30 mL in 1 BOTTLE (59316-101-11) 30 ml 2016-08-25 0000-00-00 No No Current 59316-101-12 59316010112 59 mL in 1 TUBE (59316-101-12) 59 ml 2016-08-25 0000-00-00 No No Current 59316-101-13 59316010113 59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13) 59 ml 2016-08-25 0000-00-00 No No Current 59316-101-15 59316010115 89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15) 89 ml 2016-08-25 0000-00-00 No No Current 59316-101-19 59316010119 3 mL in 1 PACKET (59316-101-19) 3 ml 2022-01-01 0000-00-00 No No Current 59316-101-20 59316010120 118 mL in 1 TUBE (59316-101-20) 118 ml 2016-08-25 0000-00-00 No No Current 59316-101-21 59316010121 81 mL in 1 TUBE 81 ml Historical 59316-101-25 59316010125 118 mL in 1 TUBE, WITH APPLICATOR (59316-101-25) 118 ml 2016-08-25 2021-12-31 No No Current 59316-101-30 59316010130 473 mL in 1 BOTTLE, PUMP (59316-101-30) 473 ml 2016-08-25 0000-00-00 No No Current 59316-101-40 59316010140 946 mL in 1 BOTTLE, PUMP (59316-101-40) 946 ml 2016-08-25 0000-00-00 No No Current 59316-101-50 59316010150 3785 mL in 1 BOTTLE, PUMP (59316-101-50) 3785 ml 2016-08-25 0000-00-00 No No Current