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 116 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hempvana Cold As Ice Pain Relief Gel-Patch MENTHOL Telebrands Corp 976a1bb2-b776-8199-e053-2995a90a1a1b 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief TROLAMINE SALICYLATE TELEBRANDS CORP d91a0fad-a38c-1580-e053-2a95a90ad268 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief - Platinum TROLAMINE SALICYLATE TELEBRANDS CORP d58da6c5-47a6-b8a8-e053-2995a90a7ce7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP df5d3312-cbc5-5db9-e053-2995a90ab055 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold as Ice Gel MENTHOL Telebrands Corp a9e103f2-778f-e49b-e053-2a95a90aa8b7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP d58e2c47-c0f4-625e-e053-2a95a90aa4d5 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Pain Relief TROLAMINE SALICYLATE Telebrands Corp 92a29553-a102-0a0e-e053-2a95a90ab24a 2024-11-20 Warnings Exact identifier application number: M017 Ultra Strength Pain Relief Gel MENTHOL TELEBRANDS CORP d91b2e09-550e-4968-e053-2995a90ae323 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream LIDOCAINE 4% Telebrands Corp c3162ba8-ac2d-5a65-e053-2995a90af246 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief LIDOCAINE TELEBRANDS CORP d91ba9b1-083f-32e9-e053-2a95a90a9bd1 2024-11-20 Warnings Exact identifier application number: M017 DynaRub PAIN RELIEVING CREAM Dynarex Corporation 7f853941-a2d7-ed26-e053-2991aa0aa9ee 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions bcdc0322-bc75-4662-9c5a-d1be1d055252 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 604a30c9-2306-47a1-bd31-94b63639dd90 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 0b489420-3b5c-43c5-aab4-0e3720acf9ce 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions dd906129-a787-4352-856d-d7a915031a6e 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Arthritis Pain Relief Cream HISTAMINE DIHYDROCHLORIDE Walgreens Company 80d3031a-7fa9-4f5b-b85e-c7c6ef314801 2024-11-20 Warnings Exact identifier application number: M017 Anti-Itch Medicated Maximum Strength BENZOCAINE AND RESORCINOL Walgreens Company 7fd86dcb-edef-4d0d-b389-7ecea595fe67 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Pain Relief BENZOCAINE Walgreens Company 7cee7234-32cd-4bf3-8a6c-0882585eec7f 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Advanced Scar Gel ADVANCED SCAR GEL Walgreens Company 2c040475-a124-485c-933e-66b452f5ab46 2024-11-20 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Clinic Pharma 274611ea-7fc2-ba3f-e063-6294a90aa50f 2024-11-19 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