FDA.reportPublic FDA data

TopCare Health Pain Relief

Product NDC
36800-670
11-digit product format
368000670
Labeler code
36800
Product ID
36800-670_42632fa6-40b5-d6c2-e063-6294a90a02d2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Camphor, and Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-08
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
.012; .057; .063 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
TopCare Health Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).012 mg/g
MENTHOL.057 mg/g
METHYL SALICYLATE.063 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal 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
dac364ef-6dcd-3fc6-e053-2a95a90a9bb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-670-40TopCare Health Pain Relief40 in 1 CARTONPATCH405
36800-670-40TopCare Health Pain Relief1 g in 1 PATCHPATCH15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-670TOPCARE HEALTH PAIN RELIEF (MENTHOL, CAMPHOR, AND METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20241212_dac364ef-6dcd-3fc6-e053-2a95a90a9bb2.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 145 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d42023-11-10WarningsExact identifier
application number: M017
SUPER BLUE STUFF Pain Relief CreamMENTHOLBLUE SPRING WELLNESS, L.L.C.066a2106-2e25-4df6-9a8d-4417ba1902052023-11-10WarningsExact identifier
application number: M017
INVIGO FLEX Pain Relief GelMENTHOLWYNNPHARM INC.909e1d8c-c517-4d6a-8682-894f042c00f82023-11-10WarningsExact identifier
application number: M017
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
application number: M017
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVINGMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsda004500-5e48-487b-b96f-520a3094096c2023-11-10WarningsExact identifier
application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVINGMENTHOL, METHYL SALICYLATERexall Sundown, LLC55c55f1c-d2b3-6363-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
NEUROFLEX Topical Pain Relieving LiquidCAMPHOR (SYNTHETIC), MENTHOLAlmark Products Inc6da3aa84-7a01-4041-8792-a4bbf49e6e4e2023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f92e71-fe2e-16f4-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M017
Teeter Renew Muscles Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCb90dc5b9-c31d-4770-a291-98d036ae87232023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR Foot and Leg RubCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC57094238-506b-48c1-8eb9-fe904be80df02023-11-10WarningsExact identifier
application number: M017
SKIN A COOL Hydrocortisone Anti-ItchHYDROCORTISONEAna-Cool, LLCe3ea7406-e494-4038-9b28-8d0a28b4b8342023-11-10WarningsExact identifier
application number: M017
Teeter reNEW MUSCLES Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCebc777b0-d141-4a62-9366-d14787eaefe02023-11-10WarningsExact identifier
application number: M017
FEELGOOD LAB Natural Pain CreamMENTHOLThe Feel Good Lab, LLC799d464c-aaf1-429a-877b-2a692397bb492023-11-10WarningsExact identifier
application number: M017
HIGHER CONTROL Male Climax Control LubricatingBENZOCAINEProduct Max Group Inc5f5fd127-34c5-403a-aa95-c9874ae794922023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f9622e-27c7-6a5d-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
FEEL GOOD LAB Natural Pain CreamMENTHOLTHE FEEL GOOD LAB, LLC774a72b1-b719-4217-846e-7f9921fd1b162023-11-10WarningsExact 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 PatchPSNdac364ef-6dcd-3fc6-e053-2a95a90a9bb25
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCDdac364ef-6dcd-3fc6-e053-2a95a90a9bb25
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSYdac364ef-6dcd-3fc6-e053-2a95a90a9bb25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-670-403680006704040 PATCH in 1 CARTON (36800-670-40) / 1 g in 1 PATCH40 patch2022-03-080000-00-00NoNoCurrent