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 44 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine HCI LIDOCAINE HCI Trifluent Pharma, LLC 47f7f06b-720e-eeec-e063-6294a90ae823 2026-01-09 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Bellus Medical, LLC 60cb89f6-e326-0773-e053-2a91aa0a33dd 2026-01-09 Warnings Exact identifier application number: M017 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
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