Home NDC 70000-0617 Leader Roll-On Cooling Pain Relief
Product NDC 70000-0617
11-digit product format 700000617
Labeler code 70000
Product ID 70000-0617_f835accf-f50d-4831-b28f-881db7ed2e01
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form GEL
Route TOPICAL
Labeler Cardinal Health, 110 dba LEADER
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-03
Substance MENTHOL, UNSPECIFIED FORM
Active strength 40 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Leader Roll-On Cooling Pain Relief
Brand name suffix Topical Analgesic
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 415974 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0617-1 Leader Roll-On Cooling Pain ReliefTopical Analgesic 74 mL in 1 BOTTLE, WITH APPLICATOR GEL 74 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0617 LEADER ROLL-ON COOLING PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [CARDINAL HEALTH, 110 DBA LEADER] 2 Current NDC, Legacy NDC, 1 package rows 20240302_e86cba40-6b10-454d-98b3-6b547456eaad.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 83 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SANA SANA Menthol External Analgesic MENTHOL Alquimia Najulam S de RL de CV 8b7edd51-e08a-4e01-9df0-8305ce17b418 2025-07-25 Warnings Exact identifier application number: M017 Hydrocortisone Intensive Healing Formula HYDROCORTISONE TARGET Corporation 682b737f-e453-4079-bf31-47a9485c7897 2025-07-25 Warnings Exact identifier application number: M017 Chigg Away BENZOCAINE Pierson Laboratories, Inc. 8372e7c1-f145-4bc5-85ab-cf831abe70ce 2025-07-24 Warnings Exact identifier application number: M017 Chigg Away BENZOCAINE Pharma Nobis, LLC e42fa1c6-d804-630f-e053-2995a90add6b 2025-07-24 Warnings Exact identifier application number: M017 Cannarelief 2000mg MENTHOL Earthmed LLC 01f810de-52ba-8beb-e063-6394a90a61c0 2025-07-24 Warnings Exact identifier application number: M017 CHING WAN HUNG SOOTHING HERBAL BALM MENTHOL TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD. ffadc904-8e9d-4cb8-815a-d583bbdb3f0b 2025-07-24 Warnings Exact identifier application number: M017 PT Elite Premium Pain Relief CAPSAICIN, MENTHOL PT ELITE PRODUCTS LLC ad251821-4c58-425d-bdcb-8dd9bd41b713 2025-07-23 Warnings Exact identifier application number: M017 Whipped Butter SPF 50 ZINC OXIDE Bloomeffects, Inc 374b62d8-e012-591f-e063-6294a90aef93 2025-07-23 Warnings Exact identifier application number: M017 Game On Xtreme MENTHOL, UNSPECIFIED FORM Natural Essentials Inc. 5a1b6192-d537-42b3-add8-22c63e7c986c 2025-07-23 Warnings Exact identifier application number: M017 AMRUTANJAN RELIEF PAIN BALM CAMPHOR , MENTHOL, METHYL SALICYLATE AMRUTANJAN HEALTH CARE LIMITED ddee6714-8b18-4d87-944b-8467fda22e6b 2025-07-23 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. 8bb89002-d7a2-4bee-b5a5-1fd1949273ef 2025-07-22 Warnings Exact identifier application number: M017 Hielo Ardiente MENTHOL Menper Distributors, Inc. 97ec516c-d2bc-47ce-82fe-bd68445d9570 2025-07-22 Warnings Exact identifier application number: M017 La Flecha Japonesa METHYL SALICYLATE Menper Distributors, Inc. 08819ad0-97c2-49bd-b923-535b94a27167 2025-07-22 Warnings Exact identifier application number: M017 Veneno de Abeja Aceite De Vibora Brand METHYL SALICYLATE Menper Distributors Inc. ad940dc8-9403-44cf-aed3-6e538cbe488b 2025-07-22 Warnings Exact identifier application number: M017 Balsamo de Vaca Mascura METHYL SALICYLATE Menper Distributors Inc. 321b6f1f-c802-4b96-99d3-e77217da11a3 2025-07-22 Warnings Exact identifier application number: M017 Abejas y Viboras Roll On METHYL SALICYLATE Menper Distributors Inc. bedf3b36-7def-099f-e053-2a95a90ac15b 2025-07-22 Warnings Exact identifier application number: M017 HealthWise Flexible 4% Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 3869cc18-5494-6142-e063-6394a90a75e5 2025-07-22 Warnings Exact identifier application number: M017 Arthcal 4% Lidocaine Patches LIDOCAINE Beijing JUNGE Technology Co., Ltd. 2e531194-67ad-c645-e063-6394a90a916c 2025-07-22 Warnings Exact identifier application number: M017 AMRUTANJAN RELIEF STRONG PAIN BALM MENTHOL, METHYL SALICYLATE AMRUTANJAN HEALTH CARE LIMITED 206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27 2025-07-22 Warnings Exact identifier application number: M017 Cold Sore Fast-Acting Pain Relief GLYCERIN AND LIDOCAINE Blistex Inc. c7511322-dd6c-441c-bf7d-ad4f0c14956a 2025-07-22 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 70000-0617-1 70000061701 74 mL in 1 BOTTLE, WITH APPLICATOR (70000-0617-1) 74 ml 2022-11-03 0000-00-00 No No Current