FDA.reportPublic FDA data

Profoot Plantar Relief Strips

Product NDC
29784-602
11-digit product format
297840602
Labeler code
29784
Product ID
29784-602_2529f702-e4dc-6c83-e063-6294a90ab89e
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE
Dosage form
PATCH
Route
TOPICAL
Labeler
Rooftop Consumer Health, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-18
Marketing end
2027-05-31
Substance
CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE
Active strength
12; 57; 63 mg/g; mg/g; mg/g
NDC exclude flag
No
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
Profoot Plantar Relief Strips

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)12 mg/g
MENTHOL57 mg/g
METHYL SALICYLATE63 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
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
853260Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65e142d8-da21-4c55-9faf-b387cb6c2c0eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-602-01Profoot Plantar Relief Strips4 in 1 POUCHPATCH42
29784-602-01Profoot Plantar Relief Strips1 in 1 BOXPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-602PROFOOT PLANTAR RELIEF STRIPS (CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE) PATCH [ROOFTOP CONSUMER HEALTH, INC.]2Current NDC, 2 package rows20241025_65e142d8-da21-4c55-9faf-b387cb6c2c0e.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 69 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Cold and Hot MedicatedMENTHOLTopco Associates LLC8739aedd-165c-5ae0-e053-2a91aa0afcd02025-10-31WarningsExact identifier
application number: M017
CVS Medicated Heat 1 ctCAPSAICINCVS Pharmacy, Inc.d41dce5b-e698-4930-8869-040b2a973f252025-10-31WarningsExact identifier
application number: M017
Coralite Medicated HeatCAPSAICINUnited Exchange Corp.a0b89c7e-80bc-43c4-840c-5fd567f60b212025-10-31WarningsExact identifier
application number: M017
Dragon with Arnical Pain ReliefMENTHOLGenomma Lab USA Inc.b4cbb7b6-cb71-9721-e053-2995a90a2b2c2025-10-31WarningsExact identifier
application number: M017
Hydrocortisone Anti-ItchHYDROCORTISONEUniversal Distribution Center LLC186afb11-06b6-4bfa-e063-6294a90aefc62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY SOLID Ointment.GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT.Guangdong Quadrant Ecological Technology Co., Ltd.425b1b9d-c33a-05e9-e063-6394a90a97a62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY Spray.GEMACHLICH ZUHAUSE NEUROPATHY SPRAY.Guangdong Quadrant Ecological Technology Co., Ltd.425b8259-af38-8d68-e063-6394a90a11202025-10-30WarningsExact identifier
application number: M017
Family Care Muscle and JointMENTHOLUnited Exchange Corp.959af9f4-7188-91a1-e053-2995a90a46652025-10-30WarningsExact identifier
application number: M017
CVS Maximum Strength Boil ReliefBENZOCAINECVS Pharmacy, Inc.0761b866-af34-42bd-adc9-3d229170d01c2025-10-30WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44ca52d-fec8-0e8c-e053-2995a90a2e602025-10-30WarningsExact identifier
application number: M017
CVS CAPSAICINCAPSAICINCVS PHARMACY9b551fe3-3842-482a-9042-63de5ad398842025-10-30WarningsExact identifier
application number: M017
TopCare Health Pain ReliefMENTHOL, CAMPHOR, AND METHYL SALICYLATETopco Associates LLCdac364ef-6dcd-3fc6-e053-2a95a90a9bb22025-10-30WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
application number: M017
LidocaineBURN RELIEFPerrigo Directc7b50f14-3481-9ebd-e053-2995a90afe1c2025-10-30WarningsExact identifier
application number: M017
Lipoflavonoid Ear Pain Kids Relief DropsLIPOFLAVONOID EAR PAIN KIDS RELIEF DROPSClarion Brands LLC4265361b-5526-c3e0-e063-6394a90a17772025-10-30WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFHEB2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f2025-10-30WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYMeijer Distribution Inc.28daaf97-b0b3-7a54-e063-6294a90a23f12025-10-30WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEMeijer Distribution Inc02f9e270-6047-83b6-e063-6394a90afc272025-10-30WarningsExact identifier
application number: M017
Muscle Rub Pain Reliever GelMENTHOL, UNSPECIFIED FORMUniversal Distribution Centre LLC18536e21-afc3-8447-e063-6394a90aabae2025-10-30WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN65e142d8-da21-4c55-9faf-b387cb6c2c0e2
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD65e142d8-da21-4c55-9faf-b387cb6c2c0e2
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY65e142d8-da21-4c55-9faf-b387cb6c2c0e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29784-602-01297840602011 POUCH in 1 BOX (29784-602-01) / 4 PATCH in 1 POUCH / 1.03 g in 1 PATCH1 pouch2023-10-182027-05-31NoNoHistorical