<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87386-003-01
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 BOX (87386-003-01) / 30 g in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
87386-0003-01
</NDC11Code>
<ProductNDC>
87386-003
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Bloomellee 12%gel Azelaic Acid Acne
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
12%azelaic Acid
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260525
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
505G(a)(3)
</ApplicationNumber>
<LabelerName>
Shenzhen Lanxi Trading Co., Ltd.
</LabelerName>
<SubstanceName>
AZELAIC ACID
</SubstanceName>
<StrengthNumber>
.12
</StrengthNumber>
<StrengthUnit>
g/g
</StrengthUnit>
<Pharm_Classes>
Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-05-26
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260525
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>