RockSauce ICY COLD PAIN RELIEF

Product NDC
81683-012
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

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
MENTHOL33.2 g/355mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81683-012-012025-02-19C16284748780-12cef2736-8090-d83d-e063-dadaa90ab31f81683-012
81683-012-012025-01-30C16284748780-12cef2736-8090-d83d-e063-dadaa90ab31f81683-012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81683-012-01RockSauce ICY COLD PAIN RELIEF355 mL in 1 BOTTLEGEL3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-012ROCKSAUCE ICY COLD PAIN RELIEF (MENTHOL) GEL [IMPLUS FOOTCARE, LLC]3Current NDC, Legacy NDC, 1 package rows20250409_bdc7c7f3-ac98-8fe9-e053-2a95a90a2663.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81683-012-0181683001201355 mL in 1 BOTTLE (81683-012-01) 355 ml2021-03-180000-00-00NoNoCurrent