FDA.reportPublic FDA data

Stool Softener

Product NDC
83324-136
11-digit product format
833240136
Labeler code
83324
Product ID
83324-136_f77811f2-a305-411a-a942-0ba744c6d5b8
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
2024-07-31
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
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
d4128fbd-32ba-4d2e-ae1a-cbe438f5b39bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-136-01Stool Softener100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-136-01EA - Each83324-136ce20acb8-1198-4d04-a079-2b8db222256912026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-136STOOL SOFTENER (DOCUSATE SODIUM SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, 1 package rows20240801_d4128fbd-32ba-4d2e-ae1a-cbe438f5b39b.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 SoftenerDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)d4128fbd-32ba-4d2e-ae1a-cbe438f5b39b2024-07-31WarningsExact identifier
ndc (product): 83324-136

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNd4128fbd-32ba-4d2e-ae1a-cbe438f5b39b3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDd4128fbd-32ba-4d2e-ae1a-cbe438f5b39b3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYd4128fbd-32ba-4d2e-ae1a-cbe438f5b39b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-136-0183324013601100 TABLET in 1 BOTTLE, PLASTIC (83324-136-01) 100 tablet2024-07-31NoNoCurrent