RockSauce Warming Massage Roll-On

Product NDC
81683-005
11-digit product format
816830005
Labeler code
81683
Product ID
81683-005_4987eebe-9adf-efba-e063-6294a90a970e
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, METHYL SALICYLATE
Dosage form
CREAM, AUGMENTED
Route
TOPICAL
Labeler
Implus Footcare, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
METHYL SALICYLATE; MENTHOL
Active strength
200; 100 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Warming Massage Roll-On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE200 mg/mL
MENTHOL100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1716100Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a2d9c3a-67fc-4c1a-b1e8-62a93880397aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81683-005-01RockSauce Warming Massage Roll-On1 in 1 BOXCREAM, AUGMENTED14
81683-005-01RockSauce Warming Massage Roll-On49.3 mL in 1 BOTTLECREAM, AUGMENTED49.34
81683-005-02RockSauce Warming Massage Roll-On1 in 1 BOXCREAM, AUGMENTED14
81683-005-02RockSauce Warming Massage Roll-On88.5 mL in 1 BOTTLECREAM, AUGMENTED88.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-005ROCKSAUCE WARMING MASSAGE ROLL-ON (MENTHOL, METHYL SALICYLATE) CREAM, AUGMENTED [IMPLUS FOOTCARE, LLC]3Current NDC, 4 package rows20250507_5a2d9c3a-67fc-4c1a-b1e8-62a93880397a.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 129 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Real Time Pain Relief Maxx Topical AnalgesicMENTHOLREAL TIME PRODUCTS, INCf45eb95a-2813-4124-bdb0-54e078a8237d2024-08-20WarningsExact identifier
application number: M017
Theracare Lidocaine Pain reliefLIDOCAINEVeridian Healthcare1d8a3679-637d-94c0-e063-6294a90a9ecf2024-08-19WarningsExact identifier
application number: M017
LidoSyncLIDOCAINE, MENTHOLiON Pharma, LLC200f883c-439a-3b99-e063-6394a90aed102024-08-19WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited09243a23-1f17-f77b-e063-6394a90a0b222024-08-19WarningsExact identifier
application number: M017
CVS Health Maximum Strength Scalp Relief Anti-itchHYDROCORTISONECVS Healthb5ef0005-8b76-4205-8be0-db3a7ed7d1c42024-08-19WarningsExact identifier
application number: M017
Rite Aid Pain Relieving Roll-OnLIDOCAINE HCLRite Aid Corporation1406590c-667c-84eb-e063-6294a90a50522024-08-16WarningsExact identifier
application number: M017
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
application number: M017
FLANAXMETHYL SALICYLATE, MENTHOL, CAPSAICINBelmora LLC5e06c688-a086-4c1c-8dab-fcead61fef402024-08-13WarningsExact identifier
application number: M017
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
application number: M017
Meijer Cold Therapy Pain RelievingMENTHOLMeijer Inc1c5b55e3-f859-71b6-e063-6294a90a633b2024-08-08WarningsExact identifier
application number: M017
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.fbbbcc67-b46d-d41a-e053-6294a90aa55d2024-08-08WarningsExact identifier
application number: M017
Cheezheng Pain Relief CreamMENTHOLTibet Cheezheng Tibetan Medicine Co. Ltd37279a3f-9207-4e4c-90d6-52735044f1042024-08-07WarningsExact identifier
application number: M017
CVS Health Hydrocortisone Anti ItchHYDROCORTISONECVS Health546a1b8a-8254-432a-85c4-38ebee5ad5682024-08-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1716100menthol 10 % / methyl salicylate 20 % Topical CreamPSN5a2d9c3a-67fc-4c1a-b1e8-62a93880397a4
1716100menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCD5a2d9c3a-67fc-4c1a-b1e8-62a93880397a4
1716100menthol 10 % / methyl salicylate 20 % Topical CreamSY5a2d9c3a-67fc-4c1a-b1e8-62a93880397a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81683-005-01816830005011 BOTTLE in 1 BOX (81683-005-01) / 49.3 mL in 1 BOTTLE1 bottle2025-05-01NoNoCurrent
81683-005-02816830005021 BOTTLE in 1 BOX (81683-005-02) / 88.5 mL in 1 BOTTLE1 bottle2025-05-01NoNoCurrent