FDA.reportPublic FDA data

Stool Softener with Laxative

Product NDC
57896-304
Requested package NDC
57896-304-01
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
SENNOSIDES50 mg/1
DOCUSATE SODIUM8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99fe8064-23f4-5d94-e053-2995a90a6641Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener with LaxativeDOCUSATE SODIUM AND SENNOSIDESGeri-Care Pharmaceutical Corp99fe8064-23f4-5d94-e053-2995a90a66412023-12-06WarningsExact identifier
ndc (package): 57896-304-01
ndc (product): 57896-304
ndc11 (package): 57896030401

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