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 136 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunBurnt PLUSLIDOCAINE HYDROCHLORIDEQuest Products, LLC.12128c75-015d-8a72-e063-6394a90ae00a2024-02-23WarningsExact identifier
application number: M017
Kroger Analgesic AnalgesicLIDOCAINE HYDROCHLORIDETHE KROGER COe6c5ead3-87d0-48ed-a4dc-86cf89ebb2852024-02-22WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEBryant Ranch Prepackfcf48536-224e-4a3d-9124-7700318239722024-02-22WarningsExact identifier
application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc8bc3956b-b82d-4ed3-8bc3-db0078466bbc2024-02-22WarningsExact identifier
application number: M017
Promescent Delay WipesBENZOCAINEAbsorptionf0a5b6be-acc5-473c-9054-b9534e769db12024-02-20WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.721658dc-3b1d-43ff-9032-e96851633cf92024-02-19WarningsExact identifier
application number: M017
Ralli Rapid Pain Relief Roll onMENTHOLTroy Manufacturing, Inc.978d5c2c-fdc4-4d25-83ec-0b9404ec80182024-02-19WarningsExact identifier
application number: M017
11681168 BURN SPRAYDynarex Corporation1183a4f5-f875-dfb0-e063-6394a90af35f2024-02-16WarningsExact identifier
application number: M017
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
application number: M017
No Mess Hydrocortisone ApplicatorHYDROCORTISONEWalgreen Co.cfefb517-9099-41c4-8a95-74414ca4032c2024-02-16WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpab9bf09d-bc8c-6d17-e053-2995a90a6c362024-02-14WarningsExact identifier
application number: M017
Natures Oil 16% MentholMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.2fbe23b7-23a3-4f0b-bc08-0205256f5d682024-02-14WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATERugby Laboratories4c11876c-57ec-4429-a8c4-fb95baa4074a2024-02-13WarningsExact identifier
application number: M017
Itch stopping CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.11368823-d4af-a536-e063-6294a90a7a2e2024-02-12WarningsExact identifier
application number: M017
Walgreens Boil Pain ReliefBOIL PAIN RELIEFWalgreens Companyd11bd769-68d0-4057-bc2a-72719f16011e2024-02-12WarningsExact identifier
application number: M017
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
application number: M017
Leader Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADER952e56ea-5cbc-4078-bd01-5d3b6864a5ce2024-02-09WarningsExact identifier
application number: M017
Leader Ultra Strength Muscle Rub Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATECardinal Health, 110 dba LEADER9d99a900-60e0-454c-98e0-2c63eb910cf12024-02-09WarningsExact identifier
application number: M017
Pain RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic RubCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.fd0ea70a-ef12-48b1-8d9d-cc5f6417f8542024-02-08WarningsExact 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