Stool Softener

Product NDC
63868-875
11-digit product format
638680875
Labeler code
63868
Product ID
63868-875_7309543d-0d54-44ee-9635-302caa83fed5
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
2018-12-31
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
Brand name suffix
Stimulant 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-875-01Stool SoftenerStimulant laxative100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-875-01EA - Each63868-875a374b41d-c498-4ab3-81fa-786104b65cf412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-875STOOL SOFTENER STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]4Current NDC, Legacy NDC, 1 package rows20240502_9467e1f7-19bb-4fb3-853b-75c4d28bb9a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN9467e1f7-19bb-4fb3-853b-75c4d28bb9a94
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD9467e1f7-19bb-4fb3-853b-75c4d28bb9a94
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY9467e1f7-19bb-4fb3-853b-75c4d28bb9a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-875-0163868087501100 TABLET in 1 BOTTLE, PLASTIC (63868-875-01) 100 tablet2018-12-310000-00-00NoNoCurrent