FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
36800-555
Requested package NDC
36800-555-10
11-digit product format
368000555
Labeler code
36800
Product ID
36800-555_6c954d95-c361-454c-b2c7-e44b98515bf9
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
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 packagepackage36800-55536800-555-10DDiscontinued 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
36800-555-10Stool Softener Laxative1 in 1 BOXTABLET13
36800-555-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-555STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]3Legacy NDC, 2 package rows20231018_2fe65209-e9d1-45a3-8c53-da63af67d857.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2fe65209-e9d1-45a3-8c53-da63af67d8573
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2fe65209-e9d1-45a3-8c53-da63af67d8573
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2fe65209-e9d1-45a3-8c53-da63af67d8573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-555-10368000555101 BOTTLE, PLASTIC in 1 BOX (36800-555-10) > 100 TABLET in 1 BOTTLE, PLASTIC2020-07-300000-00-00NoNoCurrent