FDA.reportPublic FDA data

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 64 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154fd46e-f00d-1772-e063-6394a90aba7d2025-11-12WarningsExact identifier
application number: M017
Best Choice Itch StoppingDIPHENHYDRAMINE HCLValu Merchandisers884cfd64-2cd1-8c12-e053-2995a90a89252025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLChain Drug Marketing Association884c9b47-d511-1d17-e053-2995a90a42eb2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017
Tattoo Numbing Cream CoLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC2a64b3ef-ed2d-49db-996d-f63ffecb5a1e2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
application number: M017
Now Numb Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCfed833f5-4f76-46e8-8ae1-655a9e576f702025-11-12WarningsExact identifier
application number: M017
Painless Tattoo Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC852504ec-d4fa-4cae-ba89-7ffb57df8efe2025-11-12WarningsExact identifier
application number: M017
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
application number: M017
Hello SugarLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC5f30254d-a28f-443d-8729-5c5dde4a02172025-11-12WarningsExact identifier
application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVINGMENTHOL AND CAMPHORMADISON ONE ACME INC1ba3c31b-2737-4b55-a0ea-90013a1d8cf42025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
TattooNumbLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCd9c4d664-54de-40c2-8836-72b60e6d9ac02025-11-12WarningsExact identifier
application number: M017
BeardedMoneyLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC35ff688b-75c5-4780-b294-192af780d7052025-11-12WarningsExact identifier
application number: M017
NeuroMed 7 Topical Pain ReliefLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCf199f56b-d971-4cf8-834d-babb5c2ff81a2025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals8a2b6b76-6bcc-4f52-b037-e6cbc74f83772025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals67b25c37-db32-4980-88b0-b077123459392025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Analgesic LATETRACAINE HCLSambria Pharmaceuticals, Inc.3c1e3a1d-f42b-499d-a445-1d1d3dd26c192025-11-12WarningsExact 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