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 87 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f869b3-3004-8b25-e063-6294a90a176e2025-02-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d613ab9-c87b-1f3c-e063-6394a90a31202025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUTALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6148e2-d959-6150-e063-6294a90acba52025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELONALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6175c9-abe5-4c68-e063-6394a90afc362025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.eb5d6739-ee36-cd74-e053-2a95a90ab6592025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.037b4acb-49ca-bc0a-e063-6394a90a1fcc2025-02-05WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd32055326-c229-5f10-e063-6394a90ab62c2025-02-01WarningsExact identifier
application number: M003
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact 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