FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
59726-778
11-digit product format
597260778
Labeler code
59726
Product ID
59726-778_d7e1c581-6946-4dc1-950f-01d5d13edb74
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59726-778DDiscontinued by firm2026-10-16
excluded packagepackage59726-77859726-778-10DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-778-10Stool Softener Laxative100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-778STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [P & L DEVELOPMENT, LLC]3Legacy NDC, 1 package rows20240502_84ee167d-18f2-4381-ba9e-8500869e6ef9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN84ee167d-18f2-4381-ba9e-8500869e6ef95
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD84ee167d-18f2-4381-ba9e-8500869e6ef95
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY84ee167d-18f2-4381-ba9e-8500869e6ef95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-778-1059726077810100 TABLET in 1 BOTTLE (59726-778-10) 100 tablet2021-03-260000-00-00NoNoCurrent