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 44 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tetracaine TETRACAINE Bellus Medical, LLC 60cabb5f-606b-7a74-e053-2a91aa0ac024 2026-01-09 Warnings Exact identifier application number: M017 Benzocaine BENZOCAINE Bellus Medical, LLC 60cafbaf-8ec6-46a5-e053-2a91aa0af11f 2026-01-09 Warnings Exact identifier application number: M017 PRAX PRAMOXINE HYDROCHLORIDE AvPAK dc646399-91ba-5cc1-e053-2a95a90a4f9c 2026-01-09 Warnings Exact identifier application number: M017 2.5% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC c842544a-6aea-42af-a77e-7b202371b387 2026-01-09 Warnings Exact identifier application number: M017 4% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC 7fb95135-4151-4ef4-bb6d-75251cafff6c 2026-01-09 Warnings Exact identifier application number: M017 Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Meijer Distribution, Inc 781f89c0-94ab-48de-9e0b-decb37bcde46 2026-01-09 Warnings Exact identifier application number: M017 LIDOCAINE PAIN RELIEVING Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2159fb73-cf6c-184a-e063-6394a90a1d14 2026-01-08 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 22d9ce20-1cb6-c5bd-e063-6394a90a9eca 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INT'L THERMO ANALGETICS ROLL-ON 76ef713b-e23d-7b98-e053-2991aa0aad51 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0ca84-2800-d222-e053-2995a90ad8f3 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5b0db6-8f0a-4f8e-e053-2995a90a22b7 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin Topical Analgesic CAPSAICIN AvPAK ef597423-cd01-7324-e053-2a95a90aa1ba 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN AvPAK ef5a3846-1d2f-7023-e053-2a95a90ad716 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5bb0fa-afc2-62d7-e053-2a95a90a37f4 2026-01-08 Warnings Exact identifier application number: M017 K2 Cold Therapy MENTHOL The Podiatree Co 60dce1ad-125e-396d-e053-2a91aa0a670f 2026-01-08 Warnings Exact identifier application number: M017 Burn Relief Aloe LIDOCAINE HCL Acutens 48c435fe-2670-4b80-bf01-923dc9354422 2026-01-08 Warnings Exact identifier application number: M017 Relieve A Pain LIDOCAINE Relieve A Pain LLC cafaa830-d894-4590-8928-d579cc791d79 2026-01-08 Warnings Exact identifier application number: M017 DZUL ARTHRITIS PAIN RELIEF MENTHOL Caball Sales, Inc. 159c301c-d462-bb2c-e063-6394a90a9e5a 2026-01-08 Warnings Exact identifier application number: M017 DZUL - LIDO CREME LIDOCAINE HCL, MENTHOL Caball Sales, Inc. 063387e4-a1b1-a467-e063-6294a90a6cbd 2026-01-08 Warnings Exact identifier application number: M017 TOPICAINE LIDOCAINE 4% ESBA LABORATORIES INC. 7f96e980-891e-743d-e053-2a91aa0aea5f 2026-01-08 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