<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0536-1278-03
</NDCCode>
<PackageDescription>
1 TUBE in 1 CARTON (0536-1278-03) / 15 g in 1 TUBE
</PackageDescription>
<NDC11Code>
00536-1278-03
</NDC11Code>
<ProductNDC>
0536-1278
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Rugby Lidocaine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lidocaine
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20200117
</StartMarketingDate>
<EndMarketingDate>
20260531
</EndMarketingDate>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
Rugby Laboratories
</LabelerName>
<SubstanceName>
LIDOCAINE
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/g
</StrengthUnit>
<Pharm_Classes>
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20200117
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260531
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>