FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
62011-0417
11-digit product format
620110417
Labeler code
62011
Product ID
62011-0417_1087098d-964e-4d49-b5e4-f987dc18a91c
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-01
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 productproduct62011-0417DDiscontinued by firm2026-10-15
excluded packagepackage62011-041762011-0417-1DDiscontinued by firm2026-10-15

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
62011-0417-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0417STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [STRATEGIC SOURCING SERVICES LLC]5Legacy NDC, 1 package rows20240910_abac28e1-ad2f-4b92-975b-9d8a18d43665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNabac28e1-ad2f-4b92-975b-9d8a18d436655
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDabac28e1-ad2f-4b92-975b-9d8a18d436655
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYabac28e1-ad2f-4b92-975b-9d8a18d436655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0417-162011041701100 TABLET in 1 BOTTLE, PLASTIC (62011-0417-1) 100 tablet2020-10-010000-00-00NoNoCurrent