FDA.reportPublic FDA data

Stool Softener plus Laxative

Product NDC
63868-878
11-digit product format
638680878
Labeler code
63868
Product ID
63868-878_a8f763b4-933f-4710-9dcd-3ef62de4432f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM, SENNOSIDES
Dosage form
TABLET
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-30
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener plus Laxative
Listing expiration
2026-12-31

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
ebb35e67-4e83-445e-af6e-ecb43b1d3df6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-878-60Stool Softener plus Laxative60 in 1 BOTTLETABLET604
63868-878-60Stool Softener plus Laxative1 in 1 BOXTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-878-60EA - Each63868-8785152b482-9a74-481f-a8ab-0385c41d9fe112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-878STOOL SOFTENER PLUS LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Current NDC, Legacy NDC, 2 package rows20240810_ebb35e67-4e83-445e-af6e-ecb43b1d3df6.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener plus LaxativeDOCUSATE SODIUM, SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)ebb35e67-4e83-445e-af6e-ecb43b1d3df62024-08-09WarningsExact identifier
ndc (product): 63868-878

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNebb35e67-4e83-445e-af6e-ecb43b1d3df64
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDebb35e67-4e83-445e-af6e-ecb43b1d3df64
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYebb35e67-4e83-445e-af6e-ecb43b1d3df64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-878-60638680878601 BOTTLE in 1 BOX (63868-878-60) / 60 TABLET in 1 BOTTLE1 bottle2019-10-300000-00-00NoNoCurrent