FDA.reportPublic FDA data

Stimulant Laxative Plus Stool Softener

Product NDC
68788-7674
11-digit product format
687887674
Labeler code
68788
Product ID
68788-7674_30e1b7d5-92ba-4d85-b4c0-2c0eb85f8734
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium 50 mg and Sennosides 8.6 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
part334
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-28
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Stimulant Laxative Plus Stool Softener
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1
DOCUSATE SODIUM50 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
b25b8a28-5e00-4a20-9ca3-7ed494fc4540Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7674-1Stimulant Laxative Plus Stool Softener100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
68788-7674-6Stimulant Laxative Plus Stool Softener60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7674-1EA - Each68788-7674c490be58-1c8b-4673-a2ba-0906bac13a0e12020-05-08
68788-7674-6EA - Each68788-76741f4baf00-b1eb-4c28-9b0d-3852b1350d6312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7674STIMULANT LAXATIVE PLUS STOOL SOFTENER (DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240816_b25b8a28-5e00-4a20-9ca3-7ed494fc4540.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
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGPreferred Pharmaceuticals, Inc.b25b8a28-5e00-4a20-9ca3-7ed494fc45402026-09-01WarningsExact identifier
ndc (product): 68788-7674

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNb25b8a28-5e00-4a20-9ca3-7ed494fc45406
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDb25b8a28-5e00-4a20-9ca3-7ed494fc45406
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYb25b8a28-5e00-4a20-9ca3-7ed494fc45406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7674-168788767401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7674-1) 2020-02-280000-00-00NoNoCurrent
68788-7674-66878876740660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7674-6) 2020-02-280000-00-00NoNoCurrent