FDA.reportPublic FDA data

Stool Softener with Stimulant Laxative

Product NDC
59726-855
Requested package NDC
59726-855-10
11-digit product format
597260855
Labeler code
59726
Product ID
59726-855_548cfa6e-999b-43ff-a2f3-47bf0e867dac
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-30
Marketing end
2027-02-01
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
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
Stool Softener with Stimulant Laxative

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal 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
a7fa9a4b-0fa3-4003-bfb1-8f26ca710989Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-855-10Stool Softener with Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET1007
59726-855-40Stool Softener with Stimulant Laxative400 in 1 BOTTLE, PLASTICTABLET4007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-855STOOL SOFTENER WITH STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 2 package rows20240910_a7fa9a4b-0fa3-4003-bfb1-8f26ca710989.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 Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLCa7fa9a4b-0fa3-4003-bfb1-8f26ca7109892025-11-17WarningsExact identifier
ndc (package): 59726-855-10
ndc (product): 59726-855
ndc11 (package): 59726085510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNa7fa9a4b-0fa3-4003-bfb1-8f26ca7109897
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDa7fa9a4b-0fa3-4003-bfb1-8f26ca7109897
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYa7fa9a4b-0fa3-4003-bfb1-8f26ca7109897

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-855-1059726085510100 TABLET in 1 BOTTLE, PLASTIC (59726-855-10) 100 tablet2020-04-302027-02-01NoNoCurrent