FDA.reportPublic FDA data

RockSauce FIERY HOT PAIN RELIEF

Product NDC
81683-025
11-digit product format
816830025
Labeler code
81683
Product ID
81683-025_323956e6-36bd-5542-e063-6294a90acd17
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol, Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Implus Footcare, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-21
Substance
CAPSAICIN; MENTHOL; METHYL SALICYLATE
Active strength
.00005; .25; .5 g/2.45mL; g/2.45mL; g/2.45mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RockSauce FIERY HOT PAIN RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.00005 g/2.45mL
MENTHOL.25 g/2.45mL
METHYL SALICYLATE.5 g/2.45mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A, LAV5U5022Y
Rxcui1921129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81683-025-012025-02-18C16284748780-12cef2736-a6f8-d83d-e063-dadaa90ab31f81683-025
81683-025-012025-01-30C16284748780-12cef2736-a6f8-d83d-e063-dadaa90ab31f81683-025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81683-025-01RockSauce FIERY HOT PAIN RELIEF2.45 mL in 1 POUCHCREAM2.453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-025ROCKSAUCE FIERY HOT PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [IMPLUS FOOTCARE, LLC]3Current NDC, Legacy NDC, 1 package rows20250409_cc7cbf4a-8274-e463-e053-2995a90a51e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1921129capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical CreamPSNcc7cbf4a-8274-e463-e053-2995a90a51e03
1921129capsaicin 0.02 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCDcc7cbf4a-8274-e463-e053-2995a90a51e03
1921129capsaicin 0.002 % / menthol 10 % / methyl salicylate 20 % Topical CreamSYcc7cbf4a-8274-e463-e053-2995a90a51e03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81683-025-01816830025012.45 mL in 1 POUCH (81683-025-01) 2.45 ml2021-09-210000-00-00NoNoCurrent