Kofal

Product NDC
55758-376
11-digit product format
557580376
Labeler code
55758
Product ID
55758-376_4df1c70f-4fc7-55f4-e063-6394a90aeee1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-10
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
1.25 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kofal
Brand name suffix
Max Power
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM1.25 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-376-05KofalMax Power142 g in 1 JAROINTMENT1424

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-376KOFAL MAX POWER (MENTHOL) OINTMENT [PHARMADEL LLC]2Current NDC, 1 package rows20241121_fe1f1408-b0cb-67a4-e053-6394a90ad609.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-376-0555758037605142 g in 1 JAR (55758-376-05) 142 g2023-06-10NoNoCurrent