Home NDC 81683-008-01 RockSauce Cooling Massage Gel
Product NDC 81683-008
Requested package NDC 81683-008-01
11-digit product format 816830008
Labeler code 81683
Product ID 81683-008_51e0f6d8-6897-26f7-e063-6294a90aef1a
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form GEL
Route TOPICAL
Labeler Implus Footcare, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-05
Substance MENTHOL
Active strength 60 mg/mL
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 RockSauce Cooling Massage Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 60 mg/mL
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 59 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc cba7c084-379f-4a16-aeba-b11ca6e20d8a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc d066002d-8ceb-4d16-9744-d5ca25d2ad5a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Musle and Joint MENTHOL New World Imports, Inc 013beea4-b2c2-4e84-b4cb-3125ac48e8c0 2025-12-01 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN A2A Integrated Pharmaceuticals, LLC 147f3594-7362-7a78-e063-6294a90a3e42 2025-11-30 Warnings Exact identifier application number: M017 Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Exact identifier application number: M017 Walgreen Pain Relieving Fragrance Free LIDOCAINE HYDROCHLORIDE WALGREENS CO. 62c50ded-3fc9-4f65-9bfb-1144ed2e36b4 2025-11-26 Warnings Exact identifier application number: M017 Itch Relief ITCH RELIEF GEL Neilmed Pharmaceuticals Inc. 44811828-c32e-17fc-e063-6294a90add48 2025-11-26 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON Clarion Brands LLC 4482d34d-eaca-5522-e063-6394a90a6afb 2025-11-26 Warnings Exact identifier application number: M017 Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d113dec-8832-d984-e063-6394a90ae7b3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d12f03f-dd8b-0be5-e063-6294a90a43db 2025-11-24 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL Clarion Brands LLC 445db02a-c8e8-6ebb-e063-6294a90a4301 2025-11-24 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 81683-008-01 81683000801 1 BOTTLE in 1 BOX (81683-008-01) / 354.8 mL in 1 BOTTLE 1 bottle 2026-03-05 No No Current