FDA.reportPublic FDA data

Profoot Pain Relief Patches

Product NDC
29784-601
11-digit product format
297840601
Labeler code
29784
Product ID
29784-601_252a0dfe-c0dc-640c-e063-6394a90a999b
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
KIT
Labeler
Profoot, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-12
Marketing end
2027-05-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Profoot Pain Relief Patches

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui853260

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-121-36Profoot Pain Relief Patches0.36 g in 1 PATCHPATCH0.36 g63 mg in 1g3
29784-122-36Profoot Pain Relief Patches1.3 g in 1 PATCHPATCH1.3 g63 mg in 1g3
29784-601-01Profoot Pain Relief Patches1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-601PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [PROFOOT, INC.]3Current NDC, 3 package rows20241025_06f82bde-41a1-35f6-e063-6394a90a6437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN06f82bde-41a1-35f6-e063-6394a90a64373
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD06f82bde-41a1-35f6-e063-6394a90a64373
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY06f82bde-41a1-35f6-e063-6394a90a64373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29784-121-36297840121360.36 g in 1 PATCH0.36 gHistorical
29784-122-36297840122361.3 g in 1 PATCH1.3 gHistorical
29784-601-01297840601011 KIT in 1 KIT (29784-601-01) * 1 PATCH in 1 KIT / .36 g in 1 PATCH (29784-121-36) * 2 PATCH in 1 KIT / 1.3 g in 1 PATCH (29784-122-36) 1 kit2023-10-122027-05-31NoNoHistorical