<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84209-400-03
</NDCCode>
<PackageDescription>
3 POUCH in 1 BOX (84209-400-03) / 20.27 cm2 in 1 POUCH
</PackageDescription>
<NDC11Code>
84209-0400-03
</NDC11Code>
<ProductNDC>
84209-400
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Achelon Lidocaine Patch
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lidocaine Patch 4%
</NonProprietaryName>
<DosageFormName>
PATCH
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250325
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Achelon, Inc
</LabelerName>
<SubstanceName>
LIDOCAINE
</SubstanceName>
<StrengthNumber>
7.54
</StrengthNumber>
<StrengthUnit>
mg/60.81cm2
</StrengthUnit>
<Pharm_Classes>
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250326
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>