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 106 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Compass Reduce Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.0a0b688e-50f1-3eb1-e063-6394a90a7efa2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Topical PainCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.8cb80362-5d24-1ee3-e053-2a95a90afcdf2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Roll-On Pain ReliefMENTHOLGreen Compass, Inc.b5916aa2-428c-5637-e053-2995a90a08b02025-01-01WarningsExact identifier
application number: M017
OKeeffes Working Hands Pain Relief Skin ProtectantALLANTOIN, LIDOCAINE HYDROCHLORIDEThe Gorilla Glue Company/O'Keeffe's Company0685da25-c9fa-e1cd-e063-6394a90ae1b32025-01-01WarningsExact identifier
application number: M017
Icy Hot with Lidocaine Pain RelievingLIDOCAINE HCL AND MENTHOLChattem, Inc.75b28b06-77ea-4fea-b516-2e8a0dac70372025-01-01WarningsExact identifier
application number: M017
Advanced Seal Barrier plus Pain ReliefLIDOCAINEKericure Inc.7ac95325-e6e9-4c56-9315-876c00af7c982025-01-01WarningsExact identifier
application number: M017
FixMySkin Healing Balm Fragrance-FreeHYDROCORTISONELovely Skin, Inc.c12af4c6-2f05-46ec-b901-1a4fcd7501802024-12-31WarningsExact identifier
application number: M017
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
application number: M017
Cold Therapy Pain Relief WalgreensMENTHOL 10.5%WALGREEN COMPANYf1daa68d-1b12-c28a-e053-2995a90a09492024-12-31WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAdvanced Rx of Tennessee, LLC0b7736df-c7e0-7d00-e063-6294a90aa57e2024-12-31WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
application number: M017
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving CreamLIDOCAINE, MENTHOLSato Pharmaceutical Co., Ltd.2251e96b-d050-4ec2-a6b9-6659610885bf2024-12-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESafewayaf2e2ef3-0f3f-4592-8081-b6553ade2f5a2024-12-26WarningsExact identifier
application number: M017
Comforte Menstrual Cramp Relief CreamMENTHOLPMS4PMS LLCc121537e-3333-4f35-8c77-20086158dff42024-12-26WarningsExact identifier
application number: M017
N-Labs Arcticzen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNUTRIOMO LABS PTE. LTD05ee574a-854c-4a77-be77-082055075c4d2024-12-26WarningsExact identifier
application number: M017
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
application number: M017
GNP Anti ItchCAMPHOR, MENTHOLAMERISOURCEBERGEN DRUG CORPORATIONb4f2d6f7-2287-47d8-e053-2995a90ae3352024-12-23WarningsExact identifier
application number: M017
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
application number: M017
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact 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