FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
50804-855
Requested package NDC
50804-855-10
11-digit product format
508040855
Labeler code
50804
Product ID
50804-855_ba74cf69-6b9b-4683-84a4-ff3c9cfa15d6
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium, Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-30
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-85550804-855-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
50804-855-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-855-10EA - Each50804-855173254d7-b917-49b8-8cb8-22dc059e02ed12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-855STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]4Legacy NDC, 1 package rows20240404_16daaa1e-19c3-414c-91c2-624ac573b960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN16daaa1e-19c3-414c-91c2-624ac573b9605
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD16daaa1e-19c3-414c-91c2-624ac573b9605
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY16daaa1e-19c3-414c-91c2-624ac573b9605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-855-1050804085510100 TABLET in 1 BOTTLE, PLASTIC (50804-855-10) 100 tablet2020-06-300000-00-00NoNoCurrent