Home NDC 84197-867 FlexDermal Pain Relieving Roll-On
Product NDC 84197-867
11-digit product format 841970867
Labeler code 84197
Product ID 84197-867_2d76e34f-c583-4eae-e063-6294a90a5de5
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form LIQUID
Route TOPICAL
Labeler SOLVADERM LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-24
Substance MENTHOL
Active strength 20 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 FlexDermal Pain Relieving Roll-On
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 20 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 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 84197-867-00 FlexDermal Pain Relieving Roll-On 90 mL in 1 BOTTLE LIQUID 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84197-867 FLEXDERMAL PAIN RELIEVING ROLL-ON (MENTHOL) LIQUID [SOLVADERM LLC] 1 Current NDC, 1 package rows 20250209_d4d8050e-0761-4491-8635-39c806701eb5.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 143 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PURE EASE Joint Muscle lnstant Pain Relief CAPSAICIN, MENTHOL SERENU, INC. 42bf129c-5c84-4331-b6d0-78e3be71a985 2023-11-13 Warnings Exact identifier application number: M017 PURE EASE Neur Cream Instant Deep Pain Relief CAPSAICIN, MENTHOL SERENU, INC. e46a4636-6405-440a-a05a-862c354bab54 2023-11-13 Warnings Exact identifier application number: M017 Cryomax Cooling MENTHOL LIFE WEAR TECHNOLOGIES 0a0ae5ba-9fac-45f6-e063-6294a90ad555 2023-11-13 Warnings Exact identifier application number: M017 LBri Super Aloe Stop The Pain METHYL SALICYLATE, MENTHOL, CAPSAICIN L'Bris, Pure 'N Natural 8fb2010c-c34b-4552-858d-a0188ad313ad 2023-11-11 Warnings Exact identifier application number: M017 TOTAL RELIEF HYDROCORTISONE DR. MARDER SKINCARE, LLC 2c05459c-5a2c-45ab-b534-87f966b41681 2023-11-11 Warnings Exact identifier application number: M017 Human Science Muscle Pain Relief METHYL SALICYLATE, MENTHOL Human Science, LLC 4bccc017-264b-11ce-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Village Pharma, LLC 55108ffd-d6a8-41de-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M017 Debbies Down and Dirty Deep Tissue Joint and Muscle MENTHOL DD&D Manufacturing Co., Ltd 531fe834-53e3-305f-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M017 TerraFreeze Pain Relief MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE Beyond Derma, LLC 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677 2023-11-11 Warnings Exact identifier application number: M017 GOLD ICE Pain Relief MENTHOL Eden's Answers, Inc. a1356c39-42b9-4bd8-a873-bcd40717058b 2023-11-11 Warnings Exact identifier application number: M017 RUBBING DOTS NATURAL COOL PAIN RELIEF MENTHOL Awesome Trading, LLC 137a88ff-e409-4a67-addc-883194c356ae 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE Lidocaine Hemp Oil Topical Analgesic LIDOCAINE HYDROCHLORIDE Prime Commerce, LLC 28ed2149-38d2-4062-8442-990a98a69cfc 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE PAIN RELIEVING ROLL-ON LIDOCAINE HYDROCHLORIDE, MENTHOL Prime Commerce, LLC c263d5f2-89b9-4dfd-91c8-f894e5f956c9 2023-11-11 Warnings Exact identifier application number: M017 SUGAR BRANDS Rescue Pain Relief and Recovery LIDOCAINE HYDROCHLORIDE Sugar Brands, LLC 74013709-d1d5-4425-825d-eee726718c61 2023-11-11 Warnings Exact identifier application number: M017 NATURES CRAFT LIDOCAINE Male Genital Desensitizer LIDOCAINE HYDROCHLORIDE Natures Design Products LLC 61bf1776-5c6c-4307-8348-41fa60164017 2023-11-11 Warnings Exact identifier application number: M017 CLEAN REMEDIES CR PAIN RELIEF MENTHOL Clean Remedies, LLC aea9291d-3244-401c-9607-e91107228faa 2023-11-11 Warnings Exact identifier application number: M017 Arth Arrest METHYL NICOTINATE, CAPSAICIN Key 2 Health, Inc. 495034ac-dbf5-4c55-906b-6ffcbcfd5bc2 2023-11-11 Warnings Exact identifier application number: M017 KINETIC ICE Muscle and Joint Pain Relief Cream MENTHOL No Reason, LLC 565f0e20-e534-41db-ba20-e726d578405f 2023-11-11 Warnings Exact identifier application number: M017 KARMA RUB Elemental Pain Relief LIDOCAINE HYDROCHLORIDE Elemental Bliss LLC c224fb1b-827f-461e-a58f-4020700c3e0d 2023-11-11 Warnings Exact identifier application number: M017 Bakers Best Arthritis Pain Relief with Hemp Seed HISTAMINE DIHYDROCHLORIDE Baker's Best Health Products, LLC 46415d28-99b5-4c9e-bde9-1c703595f671 2023-11-11 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84197-867-00 84197086700 90 mL in 1 BOTTLE (84197-867-00) 90 ml 2025-01-24 No No Current