Stool Softener plus Stimulant Laxative

Product NDC
70000-0526
11-digit product format
700000526
Labeler code
70000
Product ID
70000-0526_b33fb5f0-197e-4a91-b324-af6a97c29f53
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium 50 mg and Sennosides 8.6 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CARDINAL HEALTH, 110 DBA LEADER
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-23
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 mg/1; 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 plus Stimulant Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1
DOCUSATE SODIUM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3fd9ba76-42f8-4ebe-b1bc-f81f08e702ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0526-1Stool Softener plus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
70000-0526-2Stool Softener plus Stimulant Laxative200 in 1 BOTTLE, PLASTICTABLET, FILM COATED2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0526-1EA - Each70000-05264cfc67a7-a920-4617-b601-6a7e5d00239012020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0526STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG) TABLET, FILM COATED [CARDINAL HEALTH, 110 DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20241226_3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce.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 41 of 41 · 817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0526-170000052601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-1) 2019-10-230000-00-00NoNoCurrent
70000-0526-270000052602200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-2) 2025-12-23NoNoCurrent