FDA.reportPublic FDA data

RockSauce Warming Massage

Product NDC
81683-004
11-digit product format
816830004
Labeler code
81683
Product ID
81683-004_4987e7db-8bb5-cd49-e063-6294a90ac094
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, METHYL SALICYLATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Implus Footcare, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
MENTHOL; METHYL SALICYLATE
Active strength
100; 200 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
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal 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
de5f7add-1f2b-438a-ac17-753ebb53e697Available 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
81683-004-01RockSauce Warming Massage354.8 mL in 1 BOTTLECREAM354.84
81683-004-01RockSauce Warming Massage1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81683-004ROCKSAUCE WARMING MASSAGE (MENTHOL, METHYL SALICYLATE) CREAM [IMPLUS FOOTCARE, LLC]3Current NDC, 2 package rows20250507_de5f7add-1f2b-438a-ac17-753ebb53e697.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 14 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Roll Pain AwayCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547e647b-0205-221c-e063-6294a90a757c2026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LemongrassCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef5c0-bc31-d83e-e063-6394a90abfa62026-06-17WarningsExact identifier
application number: M017
Roll Pain Away LavenderCAPSAICINPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA547ef2d9-f5c7-9de1-e063-6394a90a218b2026-06-17WarningsExact identifier
application number: M017
Velloryn EXTRA STRENGTH NEUROPATHYVELLORYN EXTRA STRENGTH NEUROPATHYGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f755f-c65c-37ef-e063-6394a90aa2202026-06-17WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsExact identifier
application number: M017
Medi First Extra Strength Itch ReliefDIPHENHYDRAMINE, ZINC ACETATEUnifirst First Aid Corporation54614e5b-8c72-d308-e063-6294a90a405d2026-06-16WarningsExact identifier
application number: M017
Blue Ice AnalgesicMENTHOLDelon Laboratories (1990) Ltd184ed488-6e62-40c6-bb71-1d523280fd6b2026-06-16WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1 % Anti-Itch CreamHYDROCORTISONEUnifirst First Aid Corporation49f04e5d-746d-cbe9-e063-6294a90a7e882026-06-16WarningsExact identifier
application number: M017
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving CoolCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.41590ba1-32bb-4352-97ba-d6a3cc9d05462026-06-15WarningsExact identifier
application number: M017
HIGH POTENCY PAIN RELIEFCAPSAICINXiamen Weisiqi Technology Co., Ltd.543949a4-86ed-3734-e063-6394a90a24f22026-06-14WarningsExact identifier
application number: M017
Natucure HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD49e402ed-d314-e896-e063-6294a90a826b2026-06-14WarningsExact identifier
application number: M017
Nieapf NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e7534f-bccf-4ef4-e063-6294a90aeb7f2026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGHEALMUSZ NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49976ff7-49a4-e4ed-e063-6294a90a3f782026-06-14WarningsExact identifier
application number: M017
HEALMUSZ HEMORRHOID FISSURELIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSUREJiangxi Yudexi Pharmaceutical Co., LTD4a342ac0-6a8d-3408-e063-6394a90a9a102026-06-14WarningsExact identifier
application number: M017
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
application number: M017
HEALMUSZ NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4cbb7df5-5771-ce4b-e063-6294a90aab802026-06-14WarningsExact identifier
application number: M017
HEALMUSZ ECZEMAHYDROCORTISONE 1% ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD511e54e0-2abe-fb76-e063-6294a90ada682026-06-14WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-ItchCreamHYDROCORTISONEAcme United Corporation5425fc2b-4f25-3e64-e063-6394a90aff492026-06-13WarningsExact identifier
application number: M017
Icy Hot Pain Relieving BalmMENTHOL AND METHYL SALICYLATEChattem, Inc.40c8c02f-fa5f-4e80-81a0-48271fa6f94b2026-06-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1716100menthol 10 % / methyl salicylate 20 % Topical CreamPSNde5f7add-1f2b-438a-ac17-753ebb53e6974
1716100menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCDde5f7add-1f2b-438a-ac17-753ebb53e6974
1716100menthol 10 % / methyl salicylate 20 % Topical CreamSYde5f7add-1f2b-438a-ac17-753ebb53e6974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81683-004-01816830004011 BOTTLE in 1 BOX (81683-004-01) / 354.8 mL in 1 BOTTLE1 bottle2025-05-01NoNoCurrent