FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0363-0827
11-digit product format
003630827
Labeler code
0363
Product ID
0363-0827_6ed29f6b-e505-46b3-adcf-41d9d3bcdc42
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-30
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Brand name suffix
Plus Stimulant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui998740

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0827-20Stool Softener LaxativePlus Stimulant200 in 1 BOTTLE, PLASTICTABLET2004
0363-0827-60Stool Softener LaxativePlus Stimulant1 in 1 BOXTABLET14
0363-0827-60Stool Softener LaxativePlus Stimulant60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0827-60EA - Each0363-08270cabf0b5-68b5-4266-9449-857c98759f7912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0827STOOL SOFTENER LAXATIVE PLUS STIMULANT (DOCUSATE SODIUM AND SENNOSIDES) TABLET [WALGREENS]4Current NDC, Legacy NDC, 3 package rows20240726_db528659-768a-46e0-a340-9fbcdb25ea5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNdb528659-768a-46e0-a340-9fbcdb25ea5e4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDdb528659-768a-46e0-a340-9fbcdb25ea5e4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYdb528659-768a-46e0-a340-9fbcdb25ea5e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0827-2000363082720200 TABLET in 1 BOTTLE, PLASTIC (0363-0827-20) 200 tablet2018-09-300000-00-00NoNoCurrent
0363-0827-60003630827601 BOTTLE in 1 BOX (0363-0827-60) / 60 TABLET in 1 BOTTLE1 bottle2018-09-300000-00-00NoNoCurrent