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 72 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WICKED HAND SANITIZER WATERMELON ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0e9352-15c9-954a-e063-6294a90a7a67 2025-07-29 Warnings Exact identifier application number: M003 WICKED HAND SANITIZER STRAWBERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0e7e57-6472-6cca-e063-6294a90a63a6 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER COCONUT ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0f1b10-ed25-0949-e063-6394a90a6a80 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER MANGO ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b0fd685-c807-75e4-e063-6394a90a3d65 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER PEACH ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b104177-be18-8b50-e063-6394a90a3b39 2025-07-29 Warnings Exact identifier application number: M003 MISTIFY HAND SANITIZER CHERRY ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3b4680c7-562f-c78b-e063-6294a90a5d1a 2025-07-29 Warnings Exact identifier application number: M003 Nourishing Sanitizing Hand Wipes Eucalyptus ALCOHOL SOLUTION Noshinku 3affe837-6789-6213-e063-6294a90a9fea 2025-07-28 Warnings Exact identifier application number: M003 Nourishing Sanitizing Hand Wipes Lavendula ALCOHOL SOLUTION Noshinku 3b0016b4-ccad-5eb5-e063-6294a90a36ca 2025-07-28 Warnings Exact identifier application number: M003 Nourishing Sanitizing Hand Wipes Bergamot ALCOHOL SOLUTION Noshinku 3b0035e8-d95e-f5f2-e063-6394a90aca01 2025-07-28 Warnings Exact identifier application number: M003 Kills Hand Sanitizer ALCOHOL Dermazone LLC ced12de7-32c1-4882-af22-f5373b2ceddb 2025-07-25 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3aab23c1-53ad-9e60-e063-6394a90a26ec 2025-07-24 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 3aabb047-7277-d9cb-e063-6394a90a9224 2025-07-24 Warnings Exact identifier application number: M003 Biopure HAND SANITIZER SPRAY Quest USA Corp 3249f563-7968-e512-e063-6394a90aad52 2025-07-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Cranberry Sage ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3a1c90df-19ee-b249-e063-6394a90af33b 2025-07-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Mango Peach Splash ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3a1cd4ae-4a6e-bfcc-e063-6394a90aad03 2025-07-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Floral Morning ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3a1d0f0b-e330-f674-e063-6394a90aec49 2025-07-17 Warnings Exact identifier application number: M003 WISH 91% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LJ Pharma 449df7ac-97ac-41f3-a3c8-cf0d7c597e05 2025-07-17 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 70% ISOPROPYL ALCOHOL LJ Pharma edea3130-a766-4166-80b6-a93525f5a737 2025-07-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Coconut Sandalwood ETHYL ALCOHOL MY IMPORTS USA LLC 3a2a1165-b710-3bf6-e063-6294a90a352d 2025-07-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Cranberry Sage ETHYL ALCOHOL MY IMPORTS USA LLC 3a2a36bb-c55d-67a0-e063-6294a90a1cf4 2025-07-17 Warnings Exact identifier application number: M003
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