Home NDC 55758-377 Ubredol
Product NDC 55758-377
11-digit product format 557580377
Labeler code 55758
Product ID 55758-377_5de41c46-5644-2a19-e063-6394a90a66cf
Type HUMAN OTC DRUG
Nonproprietary name Methyl Salicylate
Dosage form OINTMENT
Route TOPICAL
Labeler Pharmadel LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-20
Substance METHYL SALICYLATE
Active strength 10 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 Ubredol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 10 g/100g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-377-03 Ubredol 85 g in 1 JAR OINTMENT 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-377 UBREDOL (METHYL SALICYLATE) OINTMENT [PHARMADEL LLC] 2 Current NDC, 1 package rows 20241121_fe96eead-1722-c05d-e053-6394a90a850f.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 48 of 152 · 3,029 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55758-377-03 55758037703 85 g in 1 JAR (55758-377-03) 85 g 2023-06-20 No No Current