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 19 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 3f2b1f48-2d78-4985-a046-9f72de5e1a9b 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 10a8face-47da-ebbe-e063-6294a90a42fe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Cream MENTHOL Reckitt Benckiser LLC 32450cbf-4ed4-402b-a30e-e08a17bba3fb 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC a227213b-e89f-7144-e053-2a95a90a7e74 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 00bb462a-27d0-6f74-e063-6394a90a90ec 2026-05-13 Warnings Exact identifier application number: M017 BioFreeze Dry Stick MENTHOL Reckitt Benckiser LLC 26d62cd2-9209-8cca-e063-6394a90a2028 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Pain Relief Set MENTHOL Reckitt Benckiser LLC 4a885eef-0364-4655-bccc-7158c76cc5b2 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless Roll-On MENTHOL Reckitt Benckiser LLC a8d59d45-0e85-43d1-affd-bbe922c4acb1 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless MENTHOL Reckitt Benckiser LLC 939dbbc3-71ec-4990-840e-7c9b8d430562 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Flexible Relief Strip MENTHOL Reckitt Benckiser LLC 6ec26bae-e395-49aa-969e-8c653d6f0b27 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Day and Overnight MENTHOL Reckitt Benckiser LLC fb5c8f89-a720-ad32-e053-6294a90a2abe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foam MENTHOL Reckitt Benckiser LLC 890191e8-99ad-489c-8f21-2592f3d31936 2026-05-13 Warnings Exact identifier application number: M017 Orajel Cold Sore Touch Free - Single Dose BENZALKONIUM CHLORIDE, BENZOCAINE Church & Dwight Co., Inc. ce40829e-941f-2548-e053-2995a90a1e0e 2026-05-13 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE GERI-CARE PHARMACEUTICAL CORP 51b7753b-8619-6ea9-e063-6294a90a4ea4 2026-05-13 Warnings Exact identifier application number: M017 DERMFREE Anti-itch Cream HYDROCORTISONE1% ANTI-ITCH CREAM Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. 519c319a-9c43-0e63-e063-6394a90ab869 2026-05-13 Warnings Exact identifier application number: M017 Valtrum TOPICAL ANALGESIC CAMPHOR, MENTHOL, METHYL SALICYLATE Laboratorios Quantium LLC f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM Reckitt Benckiser 4639201c-a67a-475f-8df6-3dc6225803ad 2026-05-12 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC bae9946a-4c68-4759-9fb3-0a61a7ad0eb7 2026-05-12 Warnings Exact identifier application number: M017 Instaflex Pain Relief Cream MENTHOL Healthy Directions, LLC 665b847a-9cfb-49fc-975b-81c97f936575 2026-05-12 Warnings Exact identifier application number: M017 Theracare Cold Therapy Pain Relief MENTHOL Veridian Healthcare 51a5a043-07b6-1c96-e063-6394a90aa926 2026-05-12 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