FDA.reportPublic FDA data

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
IngredientStrength
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
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
327038a1-b825-1199-e063-6394a90a7f5fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45728-446-99Unguentine1 in 1 CARTONOINTMENT11
45728-446-99Unguentine28 g in 1 TUBEOINTMENT281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45728-446UNGUENTINE (PHENOL, ZINC OXIDE) OINTMENT [OAKHURST COMPANY]1Current NDC, 2 package rows20250413_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 21 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
application number: M003
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
application number: M003
Lightning X BZK WIPEBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.5182df99-d825-376e-e063-6394a90a54352026-05-11WarningsExact identifier
application number: M003
Sani Mango Antiseptic Hand and Body WashCHLOROXYLENOLABC Compounding Co., Inc.29496844-08e6-456d-aa7b-9eb5c866fd872026-05-11WarningsExact identifier
application number: M003
Surgent AntisepticCHLOROXYLENOLSunCoast Paper Inc.c8cea8f7-8f51-4dc7-99e3-aca786b9ca672026-05-11WarningsExact identifier
application number: M003
PalmCHLOROXYLENOLABC Compounding Co., Inc.a641ad83-1a28-4be7-a5ce-7ef5a192f3262026-05-11WarningsExact identifier
application number: M003
Antiseptic HandCHLOROXYLENOLImage Supply, Inc.7edd2630-bd0b-473f-85ab-34c74e8a3a0f2026-05-11WarningsExact identifier
application number: M003
ChemsepticCHLOROXYLENOLRochester Midland Corporationf3109c8d-c684-47a7-b26a-32e3ba64b8382026-05-11WarningsExact identifier
application number: M003
Lynx AntibacterialCHLOROXYLENOLABC Compounding Co., Inc.b469cfb7-35bf-419d-b1dc-95dcfad611f52026-05-11WarningsExact identifier
application number: M003
1012 AntimicrobialCHLOROXYLENOLABC Compounding Co., Inc.4dc6367c-5347-4a5c-b0d0-e93a4277a8492026-05-11WarningsExact identifier
application number: M003
Ban-AidCHLOROXYLENOLPro Chem, Inc.a251093c-77d1-4a2b-ba3d-e8768656cf6c2026-05-11WarningsExact identifier
application number: M003
SANAR DECOLORIZED IODINEETHYL ALCOHOLEVI LABS518d399a-009e-c54f-e063-6294a90ab8382026-05-11WarningsExact identifier
application number: M003
Handtastic Foamy Mango Antiseptic Hand and Body WashCHLOROXYLENOLMomar Incorporateda0df742f-185c-4a7a-87f1-d22ff361e3b62026-05-11WarningsExact identifier
application number: M003
Suds High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLPro chem, Inc.00214c45-8453-49f5-b3e9-c3602fe96e202026-05-11WarningsExact identifier
application number: M003
Sani Foam Mango Antiseptic Hand and Body WashCHLOROXYLENOLDelta Foremost Chemical Corporationce1b2056-8553-4ac1-985f-9327de60a0c22026-05-11WarningsExact identifier
application number: M003
Hand Guard High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLWechem, Inc.00956253-e0e8-49b7-9015-671a14f8df732026-05-11WarningsExact identifier
application number: M003
Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876CHLOROXYLENOLABC Compounding Co., Inc.404a53ba-00dd-4952-9d58-4c46b9b45a562026-05-11WarningsExact identifier
application number: M003
Kleenex Ultra Moisturizing Hand SanitizerALCOHOLKimberly-Clark Corporation75e884bf-8e0d-41e7-adbb-4400ee3d1e072026-05-08WarningsExact identifier
application number: M003
Lightning X Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.5136065e-8dc9-0dae-e063-6294a90a3f9d2026-05-07WarningsExact identifier
application number: M003
Lightning X Iodine Prep PadsPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd.5136a99b-ef40-937e-e063-6394a90a0a952026-05-07WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45728-446-99457280446991 TUBE in 1 CARTON (45728-446-99) / 28 g in 1 TUBE1 tube2025-04-10NoNoCurrent