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 117 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Flexible Pain Relieving Lidocaine LIDOCAINE, MENTHOL Walgreen Co. 6f070fa3-a61a-4523-a470-ab58bf9400a3 2024-11-27 Warnings Exact identifier application number: M017 Benadryl Original Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Kenvue Brands LLC 920c50cb-9bdd-4a36-bb3d-c2559db73327 2024-11-26 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 884907a8-c884-4cce-ac10-9d4848fdba3e 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 7f067e95-e01c-4b9a-a02e-0af097beb18c 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 9ece9b3a-0092-4c1c-a913-c2fefcd70541 2024-11-22 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd 1936c5f4-274b-8e49-e063-6394a90ac642 2024-11-21 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine LIDOCAINE 4% Telebrands Corp 2788189e-35bc-d48c-e063-6294a90ae6c2 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Ultra Strength Muscle Rub ULTRA STRENGTH MUSCLE RUB FAMILY DOLLAR (Family Wellness) 554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Anorectal Lidocaine ANORECTAL LIDOCAINE FAMILY DOLLAR (Family Wellness) ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Hot and Cold Pain Relief HOT AND COLD PAIN RELIEF FAMILY DOLLAR (Family Wellness) b70e343b-18aa-4e45-ae8e-79d8c84ad205 2024-11-21 Warnings Exact identifier application number: M017 Signature Care Lidocaine Cream LIDOCAINE Better Living Brands LLC 5483729e-ef1a-47a2-b7cf-c19744f52073 2024-11-21 Warnings Exact identifier application number: M017 WINCO Hydrocortisone HYDROCORTISONE 1% WinCo Foods LLC 26a29de3-4b79-4a3a-93b6-a14c5e91a8c6 2024-11-21 Warnings Exact identifier application number: M017 Menthol and Zinc Oxide MENTHOL AND ZINC OXIDE Dynarex Corporation d0e43651-4215-465b-9ace-1bc23126b109 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold As Ice Pain Relief Gel-Patch MENTHOL Telebrands Corp 976a1bb2-b776-8199-e053-2995a90a1a1b 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief TROLAMINE SALICYLATE TELEBRANDS CORP d91a0fad-a38c-1580-e053-2a95a90ad268 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief - Platinum TROLAMINE SALICYLATE TELEBRANDS CORP d58da6c5-47a6-b8a8-e053-2995a90a7ce7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP df5d3312-cbc5-5db9-e053-2995a90ab055 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold as Ice Gel MENTHOL Telebrands Corp a9e103f2-778f-e49b-e053-2a95a90aa8b7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP d58e2c47-c0f4-625e-e053-2a95a90aa4d5 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Pain Relief TROLAMINE SALICYLATE Telebrands Corp 92a29553-a102-0a0e-e053-2a95a90ab24a 2024-11-20 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