Home NDC 55758-376 Kofal
Product NDC 55758-376
11-digit product format 557580376
Labeler code 55758
Product ID 55758-376_5de2e6bc-1722-ed3e-e063-6294a90a166a
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 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 Kofal
Brand name suffix Max Power
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 1.25 g/100g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-376-05 KofalMax Power 142 g in 1 JAR OINTMENT 142 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-376 KOFAL MAX POWER (MENTHOL) OINTMENT [PHARMADEL LLC] 2 Current NDC, 1 package rows 20241121_fe1f1408-b0cb-67a4-e053-6394a90ad609.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 18 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55758-376-05 55758037605 142 g in 1 JAR (55758-376-05) 142 g 2023-06-10 No No Current