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 98 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MED NAP Benzalkonium Chloride Antiseptic BENZALKONIUM CHLORIDE Acme United Corporation d7c404c1-c765-a67c-e053-2995a90a6b8e 2024-11-09 Warnings Exact identifier application number: M003 Barbie BZK ANTISEPTIC WIPE BENZALKONIUM CHLORIDE Ashtel Studios, Inc. d675eb91-80a8-4874-a2b0-c2bf69264911 2024-11-08 Warnings Exact identifier application number: M003 Barbie ALCOHOL WIPE ISOPROPYL ALCOHOL Ashtel Studios, Inc. a4a6beb0-5781-4d74-9120-7ca64e035c23 2024-11-08 Warnings Exact identifier application number: M003 MARVEL ALCOHOL WIPE ISOPROPYL ALCOHOL Ashtel Studios, Inc. f6cd4757-d6e0-46bd-827f-3f380c71858f 2024-11-07 Warnings Exact identifier application number: M003 Instant Hand Sanitizer HAND SANITIZER Raining Rose, Inc. 2656d129-df88-4489-e063-6394a90a4b49 2024-11-07 Warnings Exact identifier application number: M003 HealthWise Advanced Hand Sanitizer ETHYL ALCOHOL 70% Veridian Healthcare 261bd056-c2f9-2a69-e063-6394a90af8df 2024-11-04 Warnings Exact identifier application number: M003 Hand Sanitizer Cucumber Aloe ORGANIC ETHYL ALCOHOL Whole Foods Market, Inc. 0588ae1b-f29a-e1b6-e063-6394a90a0de1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Cucumber Aloe ETHYL ALCOHOL Whole Foods Market, Inc. 074334af-c26e-4126-e063-6394a90ae4c4 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ORGANIC ETHYL ALCOHOL Whole Foods Market, Inc. 07f708d1-11c8-eb50-e063-6294a90a3a81 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 0742f251-5fc9-c015-e063-6394a90a79b1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ETHYL ALCOHOL Whole Foods Market, Inc. 07436407-7a15-7cee-e063-6294a90a9651 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 07f7e966-e57e-dede-e063-6294a90acbf5 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. ec8c7597-a3f1-65a8-e053-2995a90a69a1 2024-11-02 Warnings Exact identifier application number: M003 Lemongrass Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25ca3908-24aa-5e4f-e063-6394a90a7a88 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Decolorized Iodine ETHYL ALCOHOL Sanvall Enterprises, Inc 16c92427-84d2-cad5-e063-6394a90af435 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Mercurochrome BENZALKONIUM CHLOLRIDE Sanvall Enterprises, Inc 16c6c2f0-0f08-e640-e063-6394a90aa01d 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Gentian Violet GENTIAN VIOLET Sanvall Enterprises, Inc 1922518d-e49b-5010-e063-6394a90a9112 2024-10-31 Warnings Exact identifier application number: M003 Lavender Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cada8c-8c80-c140-e063-6294a90a3336 2024-10-31 Warnings Exact identifier application number: M003 Peppermint Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cb382a-6e66-05e6-e063-6294a90a9165 2024-10-31 Warnings Exact identifier application number: M003 RITE AID Maximum strength pain relieving BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE RITE AID c87671cb-d736-4ec6-ab10-94dff54925b2 2024-10-30 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