<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76420-332-10
</NDCCode>
<PackageDescription>
5 POUCH in 1 BOX (76420-332-10) / 2 PATCH in 1 POUCH / 2.7 g in 1 PATCH
</PackageDescription>
<NDC11Code>
76420-0332-10
</NDC11Code>
<ProductNDC>
76420-332
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Xiclo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Diclofenac
</NonProprietaryName>
<DosageFormName>
PATCH
</DosageFormName>
<RouteName>
TRANSDERMAL
</RouteName>
<StartMarketingDate>
20250607
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Asclemed USA, Inc.
</LabelerName>
<SubstanceName>
DICLOFENAC
</SubstanceName>
<StrengthNumber>
.0125
</StrengthNumber>
<StrengthUnit>
g/g
</StrengthUnit>
<Pharm_Classes>
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250607
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>