Home NDC 45728-446 Unguentine
Product NDC 45728-446
11-digit product format 457280446
Labeler code 45728
Product ID 45728-446_327038a1-b826-1199-e063-6394a90a7f5f
Type HUMAN OTC DRUG
Nonproprietary name phenol, zinc oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Oakhurst Company
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-10
Substance PHENOL; ZINC OXIDE
Active strength .015; .066 g/g; g/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Unguentine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOL .015 g/g ZINC OXIDE .066 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 339NCG44TV Internal UNII lookup SOI2LOH54Z 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 45728-446-99 Unguentine 1 in 1 CARTON OINTMENT 1 1 45728-446-99 Unguentine 28 g in 1 TUBE OINTMENT 28 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45728-446 UNGUENTINE (PHENOL, ZINC OXIDE) OINTMENT [OAKHURST COMPANY] 1 Current NDC, 2 package rows 20250413_327038a1-b825-1199-e063-6394a90a7f5f.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 88 of 114 · 2,277 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 45728-446-99 45728044699 1 TUBE in 1 CARTON (45728-446-99) / 28 g in 1 TUBE 1 tube 2025-04-10 No No Current