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 105 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017
Capsaicin 0.025% CreamCAPSAICIN 0.025%Puretek Corporation28f00df0-c416-f17b-e063-6294a90a55702025-01-02WarningsExact identifier
application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint CreamCAMPHOR, MENTHOL, METHYL SALICYLATETai Guk Pharm. Co., Ltd.8f29ffd7-48b9-109f-e053-2995a90ab2152025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Arthritis Pain Relief Cream CapsaisinCAPSAISINTai Guk Pharm. Co., Ltd.8f286a9d-8765-21b3-e053-2a95a90ae43a2025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.8f2aa11d-d794-6f3e-e053-2995a90a1d9d2025-01-01WarningsExact identifier
application number: M017
HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.b9d033f3-4d12-a2c8-e053-2995a90ac7f12025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain Relief with MentholMENTHOLGreen Compass, Inc.0a0c212e-ae5d-8505-e063-6394a90af6222025-01-01WarningsExact 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