FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
70000-0091
11-digit product format
700000091
Labeler code
70000
Product ID
70000-0091_91e9523b-ba92-4e22-b50c-1f798ce0ba96
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-31
Substance
DOCUSATE SODIUM
Active strength
100 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 SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da5ccd75-8a2f-4f90-ae8a-97d81b8579d2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0091-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1007
70000-0091-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2507
70000-0091-3Stool Softener Laxative750 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED7507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0091-1EA - Each70000-00916dad384a-e8d6-414e-9676-91e6b32878c912021-08-05
70000-0091-2EA - Each70000-00919acee37a-b414-496f-8fb2-f534d08dc91912021-08-05
70000-0091-3EA - Each70000-0091a8b21a91-f5e2-41bf-8c55-3a7afd31db2212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0091STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]5Current NDC, Legacy NDC, 3 package rows20240111_da5ccd75-8a2f-4f90-ae8a-97d81b8579d2.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
1115005docusate sodium 100 MG Oral CapsulePSNda5ccd75-8a2f-4f90-ae8a-97d81b8579d27
1115005docusate sodium 100 MG Oral CapsuleSCDda5ccd75-8a2f-4f90-ae8a-97d81b8579d27
1115005DOSS Sodium 100 MG Oral CapsuleSYda5ccd75-8a2f-4f90-ae8a-97d81b8579d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0091-170000009101100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-1) 2021-01-310000-00-00NoNoCurrent
70000-0091-270000009102250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-2) 2021-01-310000-00-00NoNoCurrent
70000-0091-370000009103750 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-3) 2021-01-310000-00-00NoNoCurrent