FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0363-8780
Requested package NDC
0363-8780-60
11-digit product format
003638780
Labeler code
0363
Product ID
0363-8780_9293d8f3-9775-40ae-bbc0-cdb00ac31c61
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-30
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 packagepackage0363-87800363-8780-60DDiscontinued by firm2026-10-05

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
0363-8780-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICTABLET2006
0363-8780-60Stool Softener Laxative60 in 1 BOTTLETABLET606
0363-8780-60Stool Softener Laxative1 in 1 BOXTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8780STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [WALGREENS]6Legacy NDC, 3 package rows20241120_e2e58bc0-ebfe-40a7-8e9d-2990981ff6dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNe2e58bc0-ebfe-40a7-8e9d-2990981ff6dd6
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDe2e58bc0-ebfe-40a7-8e9d-2990981ff6dd6
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYe2e58bc0-ebfe-40a7-8e9d-2990981ff6dd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8780-60003638780601 BOTTLE in 1 BOX (0363-8780-60) > 60 TABLET in 1 BOTTLE1 bottle2020-07-300000-00-00NoNoCurrent