FDA.reportPublic FDA data

Topcare Cold and Hot Medicated

Product NDC
36800-860
11-digit product format
368000860
Labeler code
36800
Product ID
36800-860_4278845c-6ac0-2b43-e063-6394a90a9664
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-23
Substance
MENTHOL
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Cold and Hot MedicatedMENTHOLTopco Associates LLC8739aedd-165c-5ae0-e053-2a91aa0afcd02025-10-31WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Cold and Hot Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui420222

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-860-052022-03-01C16284748780-1d6a99b39-ebc0-a426-e053-dadaa90af4c2Topcare Cold & Holt Medicated Patch 5 ct. Large
36800-860-052022-03-01C16284748780-1d6a99b39-ebc0-a426-e053-dadaa90af4c2Topcare Cold & Holt Medicated Patch 5 ct. Large 15098A
36800-860-052022-01-28C16284748780-1d6a99b39-ebc0-a426-e053-dadaa90af4c2Topcare Cold & Holt Medicated Patch 5 ct. Large
36800-860-052022-01-28C16284748780-1d6a99b39-ebc0-a426-e053-dadaa90af4c2Topcare Cold & Holt Medicated Patch 5 ct. Large 15098A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-860-05Topcare Cold and Hot Medicated5 in 1 BOXPATCH56
36800-860-05Topcare Cold and Hot Medicated1 in 1 PATCHPATCH16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-860TOPCARE COLD AND HOT MEDICATED (MENTHOL) PATCH [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 2 package rows20241212_8739aedd-165c-5ae0-e053-2a91aa0afcd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN8739aedd-165c-5ae0-e053-2a91aa0afcd06
420222menthol 0.05 MG/MG Medicated PatchSCD8739aedd-165c-5ae0-e053-2a91aa0afcd06
420222menthol 5 % Medicated PatchSY8739aedd-165c-5ae0-e053-2a91aa0afcd06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-860-05368000860055 PATCH in 1 BOX (36800-860-05) / 1 PATCH in 1 PATCH5 patch2019-04-230000-00-00NoNoCurrent