<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
17856-1017-7
</NDCCode>
<PackageDescription>
60 SYRINGE in 1 CASE (17856-1017-7) / .6 mL in 1 SYRINGE
</PackageDescription>
<NDC11Code>
17856-1017-07
</NDC11Code>
<ProductNDC>
17856-1017
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Simethicone Infant
</ProprietaryName>
<ProprietaryNameSuffix>
Gas Relief Drops
</ProprietaryNameSuffix>
<NonProprietaryName>
Simethicone
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250220
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M002
</ApplicationNumber>
<LabelerName>
Atlantic Biologicals Corp.
</LabelerName>
<SubstanceName>
DIMETHICONE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/.3mL
</StrengthUnit>
<Pharm_Classes>
Skin Barrier Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251218
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>