FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
37808-355
11-digit product format
378080355
Labeler code
37808
Product ID
37808-355_5989bec5-677d-4d74-9df9-bca9024871f5
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-30
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

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 Laxative
Listing expiration
2026-12-31

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
4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-355-12Stool Softener Laxative120 in 1 BOTTLE, PLASTICTABLET1205
37808-355-24Stool Softener Laxative240 in 1 BOTTLE, PLASTICTABLET2405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-355STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [H E B]5Current NDC, Legacy NDC, 2 package rows20240910_4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b.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 LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b2024-09-09WarningsExact identifier
ndc (product): 37808-355

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-355-1237808035512120 TABLET in 1 BOTTLE, PLASTIC (37808-355-12) 120 tablet2020-06-300000-00-00NoNoCurrent
37808-355-2437808035524240 TABLET in 1 BOTTLE, PLASTIC (37808-355-24) 240 tablet2020-06-300000-00-00NoNoCurrent