Stool Softener Laxative

Product NDC
63868-946
11-digit product format
638680946
Labeler code
63868
Product ID
63868-946_866fb276-b4fd-4634-b66e-38a6b29bb980
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
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
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
63868-946-01Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-946STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Current NDC, Legacy NDC, 1 package rows20240502_72f8e8d7-ee38-4bd3-8711-f11fded0cede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN72f8e8d7-ee38-4bd3-8711-f11fded0cede5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD72f8e8d7-ee38-4bd3-8711-f11fded0cede5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY72f8e8d7-ee38-4bd3-8711-f11fded0cede5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-946-0163868094601100 TABLET in 1 BOTTLE, PLASTIC (63868-946-01) 100 tablet2021-03-310000-00-00NoNoCurrent