<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68788-4013-9
</NDCCode>
<PackageDescription>
99 g in 1 TUBE (68788-4013-9)
</PackageDescription>
<NDC11Code>
68788-4013-09
</NDC11Code>
<ProductNDC>
68788-4013
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Diclona
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lidocaine 4.5%, Diclofenac 1%
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
CUTANEOUS
</RouteName>
<StartMarketingDate>
20250905
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Preferred Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
DICLOFENAC SODIUM; LIDOCAINE
</SubstanceName>
<StrengthNumber>
.01; .045
</StrengthNumber>
<StrengthUnit>
g/g; g/g
</StrengthUnit>
<Pharm_Classes>
Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250905
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>