Home NDC 82645-014 Hot/Cold Menthol 16% Roll-On
Product NDC 82645-014
11-digit product format 826450014
Labeler code 82645
Product ID 82645-014_4f6f50c3-79af-1aac-e063-6294a90a1a63
Type HUMAN OTC DRUG
Nonproprietary name Hot/Cold Menthol 16% Roll-On
Dosage form LIQUID
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-14
Substance MENTHOL
Active strength 16 mg/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Hot/Cold Menthol 16% Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 mg/100mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82645-014-97 Hot/Cold Menthol 16% Roll-On 1 in 1 CARTON LIQUID 1 1 82645-014-97 Hot/Cold Menthol 16% Roll-On 74 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 74 1
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 146 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f92e71-fe2e-16f4-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M017 Teeter Renew Muscles Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC b90dc5b9-c31d-4770-a291-98d036ae8723 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR Foot and Leg Rub CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 57094238-506b-48c1-8eb9-fe904be80df0 2023-11-10 Warnings Exact identifier application number: M017 SKIN A COOL Hydrocortisone Anti-Itch HYDROCORTISONE Ana-Cool, LLC e3ea7406-e494-4038-9b28-8d0a28b4b834 2023-11-10 Warnings Exact identifier application number: M017 Teeter reNEW MUSCLES Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC ebc777b0-d141-4a62-9366-d14787eaefe0 2023-11-10 Warnings Exact identifier application number: M017 FEELGOOD LAB Natural Pain Cream MENTHOL The Feel Good Lab, LLC 799d464c-aaf1-429a-877b-2a692397bb49 2023-11-10 Warnings Exact identifier application number: M017 HIGHER CONTROL Male Climax Control Lubricating BENZOCAINE Product Max Group Inc 5f5fd127-34c5-403a-aa95-c9874ae79492 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f93076-1f68-58e6-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f9622e-27c7-6a5d-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 FEEL GOOD LAB Natural Pain Cream MENTHOL THE FEEL GOOD LAB, LLC 774a72b1-b719-4217-846e-7f9921fd1b16 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Climax Control Gel BENZOCAINE PRODUCT MAX GROUP INC 53e746cc-0078-4381-bf0b-9c8f98d66904 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Endless Love for Men BENZOCAINE PRODUCT MAX GROUP INC d0fa792d-dc04-4bdf-a22d-dea896beae5b 2023-11-10 Warnings Exact identifier application number: M017 Endless Love For Men BENZOCAINE Body Action Products, Inc 4e89cd3a-ecad-44c3-acb3-6d0810add8c0 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Higher Control Male Climax BENZOCAINE PRODUCT MAX GROUP INC 3c7fa73b-abe8-4a8d-951c-4e785d6e812c 2023-11-10 Warnings Exact identifier application number: M017 Uber Numb LIDOCAINE HYDROCHLORIDE UBERScientific, LLC 65a319a6-89d2-44c9-81d5-30327f9948cb 2023-11-10 Warnings Exact identifier application number: M017 Uber Numb LIDOCAINE HYDROCHLORIDE UBERScientific, LLC 768f3f0e-1add-404f-b869-00a9f35ad34a 2023-11-10 Warnings Exact identifier application number: M017 Zcaine Fast Acting Anesthetic LIDOCAINE PHI, Inc d072243f-6ba6-4ab6-8ebf-a2381fa9c2df 2023-11-09 Warnings Exact identifier application number: M017 Plum Smooth Plumb Numb Gelee LIDOCAINE Universal Companies, Inc. 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e 2023-11-09 Warnings Exact identifier application number: M017 Sonacaine Topical Anesthetic With Menthol LIDOCAINE Filltech USA, LLC ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a 2023-11-09 Warnings Exact identifier application number: M017 Bed Bug Instant Bite Relief LIDOCAINE P.F. Harris Mfg. Co. LLC 7f472fd0-5605-4cc6-b4b2-1267e815255c 2023-11-09 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82645-014-97 82645001497 1 BOTTLE, WITH APPLICATOR in 1 CARTON (82645-014-97) / 74 mL in 1 BOTTLE, WITH APPLICATOR 2026-04-14 No No Current