<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
67618-201-12
</NDCCode>
<PackageDescription>
2 BOTTLE in 1 PACKAGE (67618-201-12) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE
</PackageDescription>
<NDC11Code>
67618-0201-12
</NDC11Code>
<ProductNDC>
67618-201
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Colace Extra Strength
</ProprietaryName>
<ProprietaryNameSuffix>
Stool Softner
</ProprietaryNameSuffix>
<NonProprietaryName>
Docusate Sodium
</NonProprietaryName>
<DosageFormName>
CAPSULE, LIQUID FILLED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240805
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M007
</ApplicationNumber>
<LabelerName>
Atlantis Consumer Healthcare Inc.
</LabelerName>
<SubstanceName>
DOCUSATE SODIUM
</SubstanceName>
<StrengthNumber>
250
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250701
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>