<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85248-117-01
</NDCCode>
<PackageDescription>
20 g in 1 TUBE (85248-117-01)
</PackageDescription>
<NDC11Code>
85248-0117-01
</NDC11Code>
<ProductNDC>
85248-117
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Dermfree Triple Antibiotic
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Triple Antibiotic
</NonProprietaryName>
<DosageFormName>
OINTMENT
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260209
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M004
</ApplicationNumber>
<LabelerName>
Jiangxi Yudexi Pharmaceutical Co., LTD
</LabelerName>
<SubstanceName>
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B
</SubstanceName>
<StrengthNumber>
500; 3.5; 10000
</StrengthNumber>
<StrengthUnit>
[USP'U]/g; mg/g; [USP'U]/g
</StrengthUnit>
<Pharm_Classes>
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260209
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>