Home NDC 81683-003-01 RockSauce ICY COLD PAIN RELIEF
Product NDC 81683-003
Requested package NDC 81683-003-01
11-digit product format 816830003
Labeler code 81683
Product ID 81683-003_3239950d-8958-aaaa-e063-6394a90a8fa2
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 8.3 g/88.5mL
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 81683-003 81683-003-01 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 81683-003 81683-003-01 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 81683-003 81683-003-01 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 8.3 g/88.5mL
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 81683-003-01 RockSauce ICY COLD PAIN RELIEF 88.5 mL in 1 BOTTLE GEL 88.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81683-003 ROCKSAUCE ICY COLD PAIN RELIEF (MENTHOL) GEL [IMPLUS FOOTCARE, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250409_bd4fdff1-9174-31c2-e053-2a95a90a749f.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 86 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Cortisone HYDROCORTISONE CVS Pharmacy 87631be8-94b8-4718-858d-d2f30e636cce 2025-07-10 Warnings Exact identifier application number: M017 TopCare Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Topco Associates LLC c40e8e1d-d6d7-4880-99d3-011b97a5e4f3 2025-07-10 Warnings Exact identifier application number: M017 Live Better Hydrocortisone with Aloe HYDROCORTISONE The Great Atlantic & Pacific Tea Company 044e6ee2-98a6-4802-b33d-78b8551356c4 2025-07-10 Warnings Exact identifier application number: M017 Rocainol TOPICAL ANALGESIC METHYL SALICYLATE, MENTHOL Compania Internacional de Comercio, S.A.P.I de C.V. 827ec7b2-3d87-47e0-a47a-966b25732c32 2025-07-10 Warnings Exact identifier application number: M017 NumbR-X LIDOCAINE HCL Prodigy Media Inc 16329ab6-4a33-4c38-85e0-5aad9c75d61d 2025-07-10 Warnings Exact identifier application number: M017 Dr Lido LIDOCAINE HCL Prodigy Media Inc da0938f0-00e7-4502-8721-d64c71f594fc 2025-07-10 Warnings Exact identifier application number: M017 Pain Relief Patch CAMPHOR, METHYL SALICYLATE, MENTHOL CDMA, Inc. da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b 2025-07-09 Warnings Exact identifier application number: M017 ORTHOGEL Menthol 3.5% MENTHOL LiquidCapsule Manufacturing LLC 4fd4b7ac-1971-4abe-8fbb-74ab69e12061 2025-07-09 Warnings Exact identifier application number: M017 Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE AmerisourceBergen f36acdb8-a526-4bb7-a557-e1dcbbc1cf45 2025-07-08 Warnings Exact identifier application number: M017 Good Neighbor Pharmacy Hydrocortisone with Aloe HYDROCORTISONE AmerisourceBergen 0c544792-63d9-400c-9888-207c44fdc75e 2025-07-08 Warnings Exact identifier application number: M017 Good Neighbor Pharmacy Hydrocortisone HYDROCORTISONE AmerisourceBergen 58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf 2025-07-08 Warnings Exact identifier application number: M017 Publix Hydro HYDROCORTISONE Publix Super Markets Inc 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 2025-07-08 Warnings Exact identifier application number: M017 Publix hydro plus HYDROCORTISONE Publix Super Markets Inc a00d82c1-6b09-424a-be78-2603eee3fb9d 2025-07-08 Warnings Exact identifier application number: M017 Tattoo TATTOO CREAM Perfso (HK) Co., Limited 39773cab-12df-4520-e063-6294a90abc5b 2025-07-08 Warnings Exact identifier application number: M017 Neutrogena Sun Rescue After Sun Medicated Relief CAMPHOR (SYNTHETIC) Kenvue Brands LLC c95c5b64-b90f-1143-e053-2a95a90aa03c 2025-07-07 Warnings Exact identifier application number: M017 sunmark Hydrocortisone HYDROCORTISONE Strategic Sourcing Services LLC 210079e9-3d2f-4489-b468-b96b145034ed 2025-07-07 Warnings Exact identifier application number: M017 Relief Gel LIDOCAINE HCL Good Clean Love, Inc. e5fa2265-ccb7-750c-e053-2995a90aa51e 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 09ac2749-a60f-4039-8c80-a0d2eaf50c34 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 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 81683-003-01 81683000301 88.5 mL in 1 BOTTLE (81683-003-01) 88.5 ml 2021-03-18 0000-00-00 No No Current