Home NDC 81683-012-01 RockSauce ICY COLD PAIN RELIEF
Product NDC 81683-012
Requested package NDC 81683-012-01
11-digit product format 816830012
Labeler code 81683
Product ID 81683-012_3239913c-167d-afcd-e063-6394a90aa9c1
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Implus Footcare, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-18
Substance MENTHOL
Active strength 33.2 g/355mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 81683-012 81683-012-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 81683-012 81683-012-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 81683-012 81683-012-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 ICY COLD PAIN RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 33.2 g/355mL
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81683-012-01 RockSauce ICY COLD PAIN RELIEF 355 mL in 1 BOTTLE GEL 355 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81683-012 ROCKSAUCE ICY COLD PAIN RELIEF (MENTHOL) GEL [IMPLUS FOOTCARE, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250409_bdc7c7f3-ac98-8fe9-e053-2a95a90a2663.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 58 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Westlake Lidocaine LIDOCAINE HCL Westlake Pharma LLC 0c586a14-1a2a-9f42-e063-6294a90a16c1 2025-12-03 Warnings Exact identifier application number: M017 CVS Lidocaine Maximum Strength LIDOCAINE HCL CVS Pharmacy 87490c0f-a4d9-740e-e053-2a95a90a4724 2025-12-03 Warnings Exact identifier application number: M017 CVS Maximum Strength Burn LIDOCAINE HYDROCHLORIDE 4% CVS Pharmacy 4510f379-c5a4-92c3-e063-6294a90a0a32 2025-12-03 Warnings Exact identifier application number: M017 LidoPatch Pain Relief LIDOCAINE, MENTHOL JAR Laboratories 07289aa1-43ed-df31-e063-6394a90a764a 2025-12-03 Warnings Exact identifier application number: M017 Equate Pain Relief Cream 4% LIDOCAINE HCL Walmart, Inc 7d8e8a9a-5474-4c7b-e053-2991aa0a29f5 2025-12-03 Warnings Exact identifier application number: M017 Solarcaine Burn Pain Relief 4oz SOLARCAINE BURN PAIN RELIEF 4OZ WellSpring Pharmaceutical Corporation 14f23c28-c713-4868-9f46-66363bf94b2c 2025-12-03 Warnings Exact identifier application number: M017 ElixirCortiRelief HYDROCORTISONE ELIXIR HEALTHCARE USA, LLC. a6ca66f3-9759-4c98-a758-45700bc08352 2025-12-02 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE 4% Trifecta Pharmaceuticals USA, LLC. 12a27ce7-c547-7134-e063-6394a90a94bd 2025-12-02 Warnings Exact identifier application number: M017 5Kind DMSO MENTHOL, METHYL SALICYLATE 5KIND TRADING LTD 6a6c7241-f544-4784-9581-f5b172fdbec7 2025-12-02 Warnings Exact identifier application number: M017 PEDIADERMICS ECZEMA 2 HYDROCORTISONE RENU LABORATORIES, LLC da840bf6-ed65-bafc-e053-2a95a90a92d5 2025-12-02 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc 7d4e21d1-2914-4690-9084-a52abeab0958 2025-12-02 Warnings Exact identifier application number: M017 Rugby Capsaicin Cream CAPSAICIN Rugby Laboratories 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9 2025-12-02 Warnings Exact identifier application number: M017 Leader Capsaicin Pain Relief Cream CAPSAICIN Cardinal Health 110 dba LEADER a5620709-0fed-4979-e053-2a95a90ac654 2025-12-02 Warnings Exact identifier application number: M017 Hydrocortisone Acetate Antipruritic (Anti-Itch) HYDROCORTISONE ACETATE Sun Pharmaceutical Industries, Inc. 9f0b09e7-6cfd-4fd6-8631-67799edf4e08 2025-12-02 Warnings Exact identifier application number: M017 POMG NIGHT TIME PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE POMG LLC 28d7dfb0-a94c-90de-e063-6294a90a036a 2025-12-02 Warnings Exact identifier application number: M017 Thermacare Max Strength Lidocaine THERMACARE MAX STRENGTH LIDOCAINE Clarion Brands LLC 44fed887-d1e0-d205-e063-6294a90ac416 2025-12-02 Warnings Exact identifier application number: M017 SUNSET COOLING PAIN RELIEF ROLL-ON MENTHOL SUNSET NOVELTIES, INC 45037bc1-aa03-11ae-e063-6294a90a6c96 2025-12-02 Warnings Exact identifier application number: M017 SUNSET HEATING PAIN RELIEF ROLL-ON CAMPHOR SUNSET NOVELTIES, INC 45048936-f3c9-25f7-e063-6394a90ac4a9 2025-12-02 Warnings Exact identifier application number: M017 CAREALL Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM New World Imports, Inc 3a01f57a-ebc6-4724-b625-1d1ea4b85e73 2025-12-01 Warnings Exact identifier application number: M017 CareALL Arthritis and Muscle CAPSAICIN New World Imports, Inc 4867eac4-00ea-434e-b289-1c1ef0342c23 2025-12-01 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81683-012-01 81683001201 355 mL in 1 BOTTLE (81683-012-01) 355 ml 2021-03-18 0000-00-00 No No Current