Stool Softener with Laxative

Product NDC
57896-304
11-digit product format
578960304
Labeler code
57896
Product ID
57896-304_0bdcf009-4dd7-e3d1-e063-6394a90ace29
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium and Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-01
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 with 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
57896-304-01Stool Softener with Laxative100 in 1 BOTTLETABLET, FILM COATED1004
57896-304-10Stool Softener with Laxative1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-304-01EA - Each57896-30415775618-2662-4fcc-8493-78a0d700e66312020-03-10
57896-304-10EA - Each57896-3047c8fa10f-02af-4f61-8986-3f5a3eba04c212020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-304STOOL SOFTENER WITH LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]4Current NDC, Legacy NDC, 2 package rows20231207_99fe8064-23f4-5d94-e053-2995a90a6641.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN99fe8064-23f4-5d94-e053-2995a90a66414
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD99fe8064-23f4-5d94-e053-2995a90a66414
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY99fe8064-23f4-5d94-e053-2995a90a66414
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNe24638d3-7738-4185-8ce9-1845d8594cc61
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDe24638d3-7738-4185-8ce9-1845d8594cc61
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYe24638d3-7738-4185-8ce9-1845d8594cc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-304-0157896030401100 TABLET, FILM COATED in 1 BOTTLE (57896-304-01) 2019-12-010000-00-00NoNoCurrent
57896-304-10578960304101000 TABLET, FILM COATED in 1 BOTTLE (57896-304-10) 2019-12-010000-00-00NoNoCurrent