FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
69842-868
11-digit product format
698420868
Labeler code
69842
Product ID
69842-868_94041f3e-c4ed-4937-988b-b48ba41ead0b
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate calcium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-27
Substance
DOCUSATE CALCIUM
Active strength
240 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE CALCIUM240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6K7YS503HCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1245376Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-868-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-868STOOL SOFTENER LAXATIVE (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY]4Current NDC, Legacy NDC, 1 package rows20240308_cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 40 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milk of Magnesia mintMAGNESIUM HYDROXIDEMeijer, Inc.bb8ba371-f53c-1088-e053-2a95a90a4cbf2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLC00c61622-367b-0a5b-e063-6294a90a67062023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEStrategic Sourcing Services LLC003a3c0d-7a48-e44d-e063-6394a90a3f4a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp2d1be236-e136-4727-a52d-714f628800882023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d690d82-e4fb-57ad-e053-2a91aa0a38ea2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d6a8048-93e7-42e5-e053-2991aa0acabd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d7f5a38-4222-5bfb-e053-2991aa0a17e32023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDECARDINAL HEALTHaf4b6b64-97c9-a794-e053-2a95a90aaf0b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECARDINAL HEALTHaf5ddf5d-b1f5-2918-e053-2995a90a2d612023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEH E Bab998776-6b30-9f17-e053-2995a90a96cd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Babfe89c8-86f1-bd1e-e053-2995a90af7732023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEGOODSENSEa951617d-c6fa-75e0-e053-2995a90afcf82023-11-07WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKROGER COMPANYa1b04366-ff67-3bb3-e053-2a95a90a816c2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEBETTER LIVING BRANDS, LLCb9440381-df40-4bc7-e053-2995a90ae83f2023-11-07WarningsExact identifier
application number: M007
Milk of Magnesia mintMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f6027-51a0-1730-e053-2995a90a553b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83eb807-d522-4408-e053-2a95a90a79262023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f0c1c-0e90-2888-e053-2995a90a0b962023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEDOLGENCORP, INC.b6991abf-9819-701c-e053-2a95a90ac0b42023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEChain Drug Marketing Association7722145c-913c-4ed5-a9b2-a6c3430640662023-11-06WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEChain Drug Marketing Association12361478-d178-4950-9458-4e2e565655992023-11-06WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245376docusate calcium 240 MG Oral CapsulePSNcf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf4
1245376docusate calcium 240 MG Oral CapsuleSCDcf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf4
1245376DOSS Calcium 240 MG Oral CapsuleSYcf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-868-1069842086810100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-868-10) 2019-12-270000-00-00NoNoCurrent