FDA.reportPublic FDA data

Parche Leon

Product NDC
55758-039
11-digit product format
557580039
Labeler code
55758
Product ID
55758-039_3144b415-ab83-d639-e063-6294a90a7c93
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin, Camphor, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-28
Substance
CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL, UNSPECIFIED FORM
Active strength
3; .025; 1.25 g/1; g/1; g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Parche Leon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3 g/1
CAPSAICIN.025 g/1
MENTHOL, UNSPECIFIED FORM1.25 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, S07O44R1ZM, L7T10EIP3A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-039-01Parche Leon1 in 1 POUCHPATCH14
55758-039-06Parche Leon6 in 1 CARTONPATCH64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-039PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL) PATCH [PHARMADEL LLC]4Current NDC, Legacy NDC, 2 package rows20250328_a8f266fa-6e43-559e-e053-2995a90a2c75.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-039-01557580039011 PATCH in 1 POUCH (55758-039-01) 1 patch2020-02-280000-00-00NoNoCurrent
55758-039-06557580039066 POUCH in 1 CARTON (55758-039-06) / 1 PATCH in 1 POUCH (55758-039-01) 6 pouch2020-02-280000-00-00NoNoCurrent