FDA.reportPublic FDA data

Profoot Pain Relief Patches

Product NDC
29784-600
11-digit product format
297840600
Labeler code
29784
Product ID
29784-600_252a039c-519e-39ba-e063-6394a90ab32c
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
KIT
Labeler
Rooftop Consumer Health, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-26
Marketing end
2027-05-31
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 Pain Relief Patches

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
cc011b79-2761-40f7-8142-88f8e30a179aAvailable on FDA.report

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
29784-122-36Profoot Pain Relief Patches1.3 g in 1 PATCHPATCH1.3 g63 mg in 1g19
29784-600-01Profoot Pain Relief Patches1 in 1 KITKIT119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-600PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [ROOFTOP CONSUMER HEALTH, INC.]19Current NDC, Legacy NDC, 3 package rows20241025_cc011b79-2761-40f7-8142-88f8e30a179a.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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-Relief Lidocaine HCL 4%LIDOCAINE HCL 4%Medinatura New Mexico Inc.3c19aff8-fb18-78d0-e063-6294a90a94812025-12-11WarningsExact identifier
application number: M017
JointivaTROLAMINE SALICYLATE 10%Rising Pharma Holdings, Inc.3ee33cbf-7c0f-4982-b0b6-eeeb0202803b2025-12-11WarningsExact identifier
application number: M017
LMX4LIDOCAINEFerndale Laboratories, Inc.f0e7c92f-8b0b-4045-b659-af9f6e81260f2025-12-10WarningsExact identifier
application number: M017
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLALAINA HEALTHCARE PRIVATE LIMITEDc339dffe-bc9b-4fae-a50f-8db463d244c12025-12-09WarningsExact identifier
application number: M017
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsExact identifier
application number: M017
Ultra Strength Pain Relief BalmCAMPHOR, MENTHOLALAINA HEALTHCARE PRIVATE LIMITED80779d1f-0c2a-4ae5-9ed7-eb6877f734ba2025-12-09WarningsExact identifier
application number: M017
Pain Relief BalmMENTHOL AND CAMPHORALAINA HEALTHCARE PRIVATE LIMITED12d76b8f-4b1d-4f2d-9722-0adb55093cc42025-12-09WarningsExact identifier
application number: M017
Trojan Extended PleasureBENZOCAINEChurch & Dwight Co., Inc.be731682-4174-649a-e053-2a95a90a39872025-12-09WarningsExact identifier
application number: M017
Stopain Clinical ContinuousMENTHOLTroy Manufacturing, Inc.65f8d212-0f0e-4893-b6af-bd68bba464432025-12-09WarningsExact identifier
application number: M017
Pain and Itch Relief 4% LidocaineLIDOCAINEWalgreensf84e76a9-6af6-4fd1-be4e-efa05728cbfd2025-12-09WarningsExact identifier
application number: M017
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
application number: M017
Extra Strength Cold-Hot Medicated PatchesMENTHOLCardinal Health, 110 dba LEADERa2895c03-747c-4220-8052-4f04280626222025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER5feae39e-3ab8-4cda-b9e8-dc221aea24172025-12-08WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATECardinal Health, 110 dba LEADERf8837b69-8d85-448c-a4b4-be911bca1f6c2025-12-08WarningsExact identifier
application number: M017
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER3be6defd-f429-4dc7-8b37-5910705c0b812025-12-08WarningsExact 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 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

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
29784-600-01297840600011 KIT in 1 KIT (29784-600-01) * 4 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 kit2018-09-262027-05-31NoNoCurrent