RockSauce ICY COLD PAIN RELIEF

Product NDC
81683-003
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage81683-003-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage81683-003-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81683-003-010efc9e666f02…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
IngredientStrength
MENTHOL8.3 g/88.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd4fdff1-9174-31c2-e053-2a95a90a749fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81683-003-012025-02-18C16284748780-12cef2736-6f02-d83d-e063-dadaa90ab31f81683-003
81683-003-012025-01-30C16284748780-12cef2736-6f02-d83d-e063-dadaa90ab31f81683-003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81683-003-01RockSauce ICY COLD PAIN RELIEF88.5 mL in 1 BOTTLEGEL88.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-003ROCKSAUCE ICY COLD PAIN RELIEF (MENTHOL) GEL [IMPLUS FOOTCARE, LLC]3Current NDC, Legacy NDC, 1 package rows20250409_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 127 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caring Mill Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare22ca137a-576c-a13c-e063-6394a90ae7fc2024-09-23WarningsExact identifier
application number: M017
Signature Care Anti ItchHYDROCORTISONESafewayed0eb068-3ce6-423d-a7f8-c3456b7f60402024-09-23WarningsExact identifier
application number: M017
members mark hydrocortisoneHYDROCORTISONESam's West Inc218f0dcd-fa67-4935-8019-ecbbd53ed2f72024-09-23WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.a07496e0-6fc2-4190-8a01-f513134ffb922024-09-23WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLWhitestone Products LLC2301fed7-0fa9-450d-8b1b-006f53235be02024-09-21WarningsExact identifier
application number: M017
Tibetree Cheezheng Joint Analgesic PatchCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd65a8a63f-1864-473e-be72-7840a6a5dee72024-09-20WarningsExact identifier
application number: M017
Cold Ice Analgesic GelMENTHOLDabur India Limited22915b2f-5f76-3e38-e063-6394a90a07b42024-09-20WarningsExact identifier
application number: M017
Exchange Select HydrocortisoneHYDROCORTISONEArmy & Air Force Exchange Service1b709db3-7dc1-4756-a8a0-dddda875dc572024-09-19WarningsExact identifier
application number: M017
LidocaineLIDOCAINEStratus Pharmaceuticals Ince1a8d4a7-01f7-4bab-8d09-875c461b3b612024-09-19WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Strategic Sourcing Services, LLC2216d799-7f6f-cab7-e063-6294a90a8d6c2024-09-14WarningsExact identifier
application number: M017
Meijer Analgesic Lidocaine Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Incf5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa2024-09-12WarningsExact identifier
application number: M017
leader anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECardinal Health 110, LLC. dba Leadere1aab35b-80d9-4515-afb7-8c662bc5d0282024-09-11WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.849c3601-2bc8-0991-e053-2a91aa0a5e7f2024-09-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - ArthritisMENTHOL 8%Telebrands Corpc22cf1a5-0d5d-5ea5-e053-2995a90a333b2024-09-02WarningsExact identifier
application number: M017
Itch and Rash CreamHYDROCORTISONEWildman Business Group1f95757d-a434-f02a-e063-6294a90a2d122024-09-01WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEWildman Business Group1fd1a4b3-b6fd-0d4c-e063-6394a90a36802024-09-01WarningsExact identifier
application number: M017
Thera Care Cold Hot Medicated PatchMENTHOLVeridian Healthcareb1ce129d-06a1-7755-e053-2995a90abd7d2024-08-29WarningsExact identifier
application number: M017
BIOSAVIA External Analgesic Pain ReliefCAPSAICINBIOSAVIA USA, LLC814aa66b-7719-4a29-a84e-18290367e9c72024-08-28WarningsExact identifier
application number: M017
Careland Plantar Fasciitis Hydrogel Pain PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.0e2f29c2-2e95-4be0-b7e9-f1761a1321a52024-08-21WarningsExact identifier
application number: M017
Careland Max Strength Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.265b8dd7-64a4-4bc2-a91c-26c761c2090b2024-08-21WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81683-003-018168300030188.5 mL in 1 BOTTLE (81683-003-01) 88.5 ml2021-03-180000-00-00NoNoCurrent