Home NDC 50268-820 Urea 20
Product NDC 50268-820
11-digit product format 502680820
Labeler code 50268
Product ID 50268-820_48379414-bcb9-1797-e063-6394a90aa8fd
Type HUMAN OTC DRUG
Nonproprietary name Urea
Dosage form GEL
Route TOPICAL
Labeler AvPAK
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-09-19
Substance UREA
Active strength 200 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Urea 20
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UREA 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8W8T17847W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50268-820-85 Urea 20 1 in 1 CARTON GEL 1 4 50268-820-85 Urea 20 85 g in 1 TUBE GEL 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-820 UREA 20 (UREA) GEL [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20240308_e994fa05-a457-2555-e053-2a95a90ae83b.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-820-85 50268082085 1 TUBE in 1 CARTON (50268-820-85) / 85 g in 1 TUBE 1 tube 2022-09-19 0000-00-00 No No Current