Stool Softener Laxative

Product NDC
55319-565
11-digit product format
553190565
Labeler code
55319
Product ID
55319-565_1dc35b90-2641-4168-a801-212005aef90a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium, Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
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
55319-565-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-565STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]5Current NDC, 1 package rows20240907_1eee3ed5-09f7-44a9-abc5-98336e493fe8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN1eee3ed5-09f7-44a9-abc5-98336e493fe86
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD1eee3ed5-09f7-44a9-abc5-98336e493fe86
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY1eee3ed5-09f7-44a9-abc5-98336e493fe86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-565-1055319056510100 TABLET in 1 BOTTLE, PLASTIC (55319-565-10) 100 tablet2023-07-01NoNoCurrent