Stool Softener Laxative

Product NDC
63868-946
11-digit product format
638680946
Labeler code
63868
Product ID
63868-946_866fb276-b4fd-4634-b66e-38a6b29bb980
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 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 Laxative
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal 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
72f8e8d7-ee38-4bd3-8711-f11fded0cedeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-946-01Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-946STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Current NDC, Legacy NDC, 1 package rows20240502_72f8e8d7-ee38-4bd3-8711-f11fded0cede.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 28 of 41 · 817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffaeff6-c48b-1558-e053-2995a90ab52f2024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATESTRATEGIC SOURCING SERVICESf9e1291a-f64d-2431-e053-6394a90a35f12024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEAMERISOURCE BERGENf384094e-c4d2-3882-e053-2995a90a77942024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEAMERISOURCE BERGENf3847b0f-802d-73d7-e053-2a95a90a5bbe2024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATESTRATEGIC SOURCING SERVICESf9e1291a-f650-2431-e053-6394a90a35f12024-12-23WarningsExact identifier
application number: M007
Leader Regular Strength Chocolate Laxative sennosidesSENNOSIDESCARDINAL HEALTH1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e2024-12-23WarningsExact identifier
application number: M007
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEWalgreensc8ea170b-57b5-4643-ba88-4cf2ae1bf6a02024-12-23WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMeijer, Inc.b09a234e-962d-49fc-a72e-898547b2f0992024-12-23WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
application number: M007
Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equateSENNOSIDESWal-Mart Stores Inc10dc8b4d-8136-44a5-a2ce-30295866cd3b2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best ChoiceSENNOSIDESValu Merchandisers Company4b7cab4b-a610-4fb9-ac31-011975f1b29c2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG healthSENNOSIDESDolgencorp Inc.88dc2f9b-18ca-4e21-8faa-5339f82a2a752024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare healthSENNOSIDESTopco Associatesf051b302-f70e-4ab6-bb69-f69b45f2642e2024-12-23WarningsExact identifier
application number: M007
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEC.D.M.A., Inc.e80be2b6-a0ca-4838-b956-a1debb065d572024-12-23WarningsExact identifier
application number: M007
ConlaxBISACODYLBliss GVS Pharma Limited7d25990b-6f7c-1eac-e053-2a91aa0a70222024-12-21WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
application number: M007
SENNA SyrupSENNOSIDES A AND BSDA Laboratories, Inc.cfc6ab2f-5376-46fc-ac58-7dedd70100062024-12-20WarningsExact identifier
application number: M007
Fiber TherapyCALCIUM POLYCARBOPHILWal-Mart Stores, Inc.3432a4a6-aeb1-4a72-8451-5903266931fa2024-12-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILUNITED NATURAL FOODS, INC. DBA UNFIf7236bbc-8ded-4e11-8cce-b0a2255e14502024-12-20WarningsExact identifier
application number: M007
Fiber CapsCALCIUM POLYCARBOPHILGuardian Drug Company31e6b0c7-1d4a-4660-ae87-9d18e0001dcd2024-12-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN72f8e8d7-ee38-4bd3-8711-f11fded0cede5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD72f8e8d7-ee38-4bd3-8711-f11fded0cede5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY72f8e8d7-ee38-4bd3-8711-f11fded0cede5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-946-0163868094601100 TABLET in 1 BOTTLE, PLASTIC (63868-946-01) 100 tablet2021-03-310000-00-00NoNoCurrent