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 98 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Exact identifier application number: M017 Peppermint soothing cream CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL Henan Lijitang Medical Technology Co., Ltd. 2f6bc332-3006-710d-e063-6394a90acea5 2025-03-03 Warnings Exact identifier application number: M017 Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN FOURSTAR GROUP USA, INC. dcff0a2d-7190-4b0c-abde-ba009b8ef005 2025-02-28 Warnings Exact identifier application number: M017 GoodSense Anti-Itch DIPHENHYDRAMINE HCL, ZINC ACETATE Geiss, Destin & Dunn, Inc 2f38bdfc-6135-1b8a-e063-6294a90a6703 2025-02-28 Warnings Exact identifier application number: M017 Capsaicin 0.05% Cream CAPSAICIN 0.05% Puretek Corporation 2cf17a28-711f-77bd-e063-6394a90a7061 2025-02-28 Warnings Exact identifier application number: M017 Lidocaine Pain-Relief Patches LIDOCAINE PATCH Meijer, Inc 2f247929-6bff-1e59-e063-6394a90acdba 2025-02-27 Warnings Exact identifier application number: M017 Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Exact identifier application number: M017 Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL FOURSTAR GROUP USA, INC. 0007e3ea-882b-4000-8e70-2bcec2c08613 2025-02-26 Warnings Exact identifier application number: M017 Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Exact identifier application number: M017 Icy Hot Pro No-Mess CAMPHOR, MENTHOL Chattem, Inc. 9e8fedf5-fb59-4531-b288-715f851ee05b 2025-02-26 Warnings Exact identifier application number: M017 Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Exact identifier application number: M017 Tylenol Precise Nighttime Pain Relieving CAMPHOR, MENTHOL Kenvue Brands LLC 2ef4fe16-0820-6aad-e063-6294a90a8449 2025-02-25 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Preferred Pharmaceuticals Inc. c259ef92-5d07-4590-adf1-3a106333eee0 2025-02-21 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Exact identifier application number: M017 AVCOO Pain Relief Roll On MENTHOL ADP Health Limited 420d8cdc-f47f-4d33-bf25-9033ff266c49 2025-02-19 Warnings Exact identifier application number: M017 AVCOO Pain Relief MENTHOL ADP Health Limited 700ce2cf-749e-40be-91c3-850d9b2168ca 2025-02-19 Warnings Exact identifier application number: M017 Sunburn Relief Gel LIDOCAINE HCL Jell Pharmaceuticals Pvt. Ltd 2e7c49de-5438-4858-e063-6294a90ad98c 2025-02-19 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