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 135 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC1369e70f-7a61-7078-e063-6394a90a9a882024-03-11WarningsExact identifier
application number: M017
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
application number: M017
Dermachange Aid Anti-ItchDIPHENHYDRAMINE HCLPrivate Label Beauty and Wellness12ed906c-d028-0ff7-e063-6394a90aaa522024-03-05WarningsExact identifier
application number: M017
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
application number: M017
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
application number: M017
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
application number: M017
Maximum Strength Scalp Itch Relief Anti-itchHYDROCORTISONERite Aid55569563-fc38-4f97-8e74-9f96e31733842024-02-28WarningsExact identifier
application number: M017
Walgreens Eczema ReliefHYDROCORTISONE ACETATEWalgreen Co.4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c2024-02-28WarningsExact identifier
application number: M017
meijer Cold Therapy Pain Relieving analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incfb163112-d84d-418d-a410-3214c0ee4b5a2024-02-28WarningsExact 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