Stool Softener

Product NDC
36800-084
11-digit product format
368000084
Labeler code
36800
Product ID
36800-084_a1ec806f-8477-4eb3-ae91-ea2e29530f1e
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-31
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
Plus 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-084-01Stool SoftenerPlus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET1005
36800-084-01Stool SoftenerPlus Stimulant Laxative1 in 1 BOXTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-084-01EA - Each36800-08434660ce1-01f6-4770-b186-cbf01104fc2a12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-084STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 2 package rows20240621_3b184800-649b-45d0-9586-8055d6d7fe08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3b184800-649b-45d0-9586-8055d6d7fe085
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3b184800-649b-45d0-9586-8055d6d7fe085
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3b184800-649b-45d0-9586-8055d6d7fe085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-084-01368000084011 BOTTLE, PLASTIC in 1 BOX (36800-084-01) / 100 TABLET in 1 BOTTLE, PLASTIC2016-01-310000-00-00NoNoCurrent