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 19 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.9019ae9e-da3e-4ed1-b83e-d9a6375e9c302025-11-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMFamily Dollar (FAMILY WELLNESS)d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c2025-11-25WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMarlex Pharmaceuticals Inc5ca287a3-c4f6-402d-978e-cd1328bdbc472025-11-21WarningsExact identifier
application number: M007
SAMS WESTPSYLLIUM HUSKSAM'S WEST INC2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac02025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corpbb47ad1f-251c-491e-8ddd-6f6f719efa152025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association440a96bb-9e68-bdcc-e063-6294a90a67932025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association4277b174-4ce5-4950-8e9b-75e3c019a8f32025-11-20WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9237a-7895-388d-e053-2991aa0a92b02025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9305b-2997-49d3-e053-2991aa0a1fa12025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3c8f5b69-56f2-4e9d-e054-00144ff88e882025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3cdf1975-2607-14f5-e054-00144ff8d46c2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDERITE AID PHARMACY60284706-445f-f795-e053-2a91aa0a0a122025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp9f588e9b-56c5-4426-89fc-7b83e2d0ad1a2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFact Productsaebbdd10-0650-6efe-e053-2a95a90a0ab22025-11-19WarningsExact identifier
application number: M007
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
application number: M007
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
application number: M007
Topco Fiber Therapy Sugar FreePSYLLIUM HUSKTOPCO ASSOCIATES LLC2c61e73e-b3f7-4ab2-8bda-e65a2c0b35602025-11-10WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact 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