FDA.reportPublic FDA data

PROFOOT

Product NDC
29784-121
Requested package NDC
29784-121-06
11-digit product format
297840121
Labeler code
29784
Product ID
29784-121_4aed7767-d562-4cb0-96bb-be7703d65fa4
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
PATCH
Route
TOPICAL
Labeler
Profoot, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-09-26
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE
Active strength
12 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage29784-12129784-121-06DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 1g19
29784-121-36Profoot Pain Relief Patches0.36 g in 1 PATCHPATCH0.36 g63 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-121PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [ROOFTOP CONSUMER HEALTH, INC.]19Legacy NDC20241025_cc011b79-2761-40f7-8142-88f8e30a179a.zip
29784-121PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [PROFOOT, INC.]3Legacy NDC20241025_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 PatchPSNcc011b79-2761-40f7-8142-88f8e30a179a19
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCDcc011b79-2761-40f7-8142-88f8e30a179a19
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSYcc011b79-2761-40f7-8142-88f8e30a179a19
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
29784-121-06297840121066 PATCH in 1 BOX (29784-121-06) > .36 g in 1 PATCH (29784-121-36) 6 patch2018-09-270000-00-00NoNoCurrent