FDA.reportPublic FDA data

Stool Softener

Product NDC
67091-328
11-digit product format
670910328
Labeler code
67091
Product ID
67091-328_de37fac7-13ad-4b27-95c0-b4a308d700ad
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
WinCo Foods, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-31
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
Brand name suffix
with 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
3803830c-187d-4403-9606-db036418386fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-328-60Stool Softenerwith laxative60 in 1 BOTTLE, PLASTICTABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-328STOOL SOFTENER WITH LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [WINCO FOODS, LLC]6Current NDC, Legacy NDC, 1 package rows20240808_3803830c-187d-4403-9606-db036418386f.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 with laxativeDOCUSATE SODIUM AND SENNOSIDESWinCo Foods, LLC3803830c-187d-4403-9606-db036418386f2024-08-07WarningsExact identifier
ndc (product): 67091-328

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3803830c-187d-4403-9606-db036418386f6
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3803830c-187d-4403-9606-db036418386f6
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3803830c-187d-4403-9606-db036418386f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-328-606709103286060 TABLET in 1 BOTTLE, PLASTIC (67091-328-60) 60 tablet2018-12-310000-00-00NoNoCurrent