FDA.reportPublic FDA data

Stimulant Laxative Plus Stool Softener

Product NDC
50804-304
11-digit product format
508040304
Labeler code
50804
Product ID
50804-304_1dd8d066-303d-d5c1-e063-6394a90a5b71
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium and Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GOOD SENSE
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
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
Stimulant Laxative Plus Stool Softener
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES50 mg/1
DOCUSATE SODIUM8.6 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
17cdef7b-71bf-b4a6-e063-6294a90a5b74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-304-10Stimulant Laxative Plus Stool Softener100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-304-10EA - Each50804-304bf0d9db9-96c4-4b92-b817-2ecf23b5a98712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-304STIMULANT LAXATIVE PLUS STOOL SOFTENER (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [GOOD SENSE]2Current NDC, 1 package rows20240723_17cdef7b-71bf-b4a6-e063-6294a90a5b74.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
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESGOOD SENSE17cdef7b-71bf-b4a6-e063-6294a90a5b742024-07-22WarningsExact identifier
ndc (product): 50804-304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN17cdef7b-71bf-b4a6-e063-6294a90a5b742
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD17cdef7b-71bf-b4a6-e063-6294a90a5b742
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY17cdef7b-71bf-b4a6-e063-6294a90a5b742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50804-304-1050804030410100 TABLET, FILM COATED in 1 BOTTLE (50804-304-10) 2024-06-01NoNoCurrent