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 92 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Ultra OTC Strength Pain Relief CreamCAMPHOR, MENTHOL, AND METHYL SALICYLATEVeridian Healthcare36c3bbf9-a559-4c0d-e063-6394a90a8a1a2025-06-04WarningsExact identifier
application number: M017
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
application number: M017
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
application number: M017
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJ&A Digital Inc.d4b09055-b93e-466f-9e24-cae098af6e242025-06-02WarningsExact identifier
application number: M017
RE-LEVEMENTHOLSOMBRA COSMETICS INC.b4b39d79-0439-41e7-adca-e5ccb8f44e402025-05-29WarningsExact identifier
application number: M017
PAIN NO MORE THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.f7bacc8e-6a8b-4cd8-bd0e-68890bee58182025-05-29WarningsExact identifier
application number: M017
DermaD ANTI-ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.8f4a57cb-0a5b-42b0-a325-1f92f3942ad92025-05-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.f7aecfb4-c194-4554-8d05-4e46005e654b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.b679ed7b-9d88-4eff-9743-567affe0fe2b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll OnMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.28eb8273-5789-4f33-bbbe-3a5ec7bc79292025-05-27WarningsExact identifier
application number: M017
AUVON Pain Relief CreamLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.358c2632-3b90-1c54-e063-6294a90ad4612025-05-22WarningsExact identifier
application number: M017
WelAhead by Welmate Lidocaine 5% Roll-onLIDOCAINE 5%OTC PHARM LLC0b75e83e-8c7b-6247-e063-6294a90ac4132025-05-21WarningsExact identifier
application number: M017
Bliss RepublicLIDOCAINE NUMBING EXTRA STRENGTH CREAMSargass Group Limited Liability Company35aba13a-95e6-a395-e063-6294a90a5bdc2025-05-21WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporatione911478f-7153-4700-b945-92ec54972f452025-05-21WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHPreferred Pharmaceuticals Inc.0976a898-8d79-4b85-b473-c8ad32b4fd002025-05-20WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact 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