Stool Softener

Product NDC
50804-424
11-digit product format
508040424
Labeler code
50804
Product ID
50804-424_352f3947-64f9-4453-b954-e174260b93c7
Type
HUMAN OTC DRUG
Nonproprietary name
Stool Softener
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Good Sense
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-18
Substance
DOCUSATE SODIUM
Active strength
100 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-424-24Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED12
50804-424-24Stool Softener25 in 1 BOTTLECAPSULE, LIQUID FILLED252
50804-424-25Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED12
50804-424-25Stool Softener25 in 1 BOTTLECAPSULE, LIQUID FILLED252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-424-25EA - Each50804-424d2470d21-3131-480f-94ff-83e2e7b7c9e312025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-424STOOL SOFTENER CAPSULE, LIQUID FILLED [GOOD SENSE]1Current NDC, 4 package rows20240619_64266195-1b07-42c2-98a7-d76c12f74776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN64266195-1b07-42c2-98a7-d76c12f747762
1115005docusate sodium 100 MG Oral CapsuleSCD64266195-1b07-42c2-98a7-d76c12f747762
1115005DOSS Sodium 100 MG Oral CapsuleSY64266195-1b07-42c2-98a7-d76c12f747762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50804-424-24508040424241 in 1 CARTONHistorical
50804-424-25508040424251 BOTTLE in 1 CARTON (50804-424-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-06-18NoNoCurrent