FDA.reportPublic FDA data

Stool Softener with Laxative

Product NDC
71335-2522
Requested package NDC
71335-2522-2
11-digit product format
713352522
Labeler code
71335
Product ID
71335-2522_50ff216f-56d0-4d51-ac30-f08ba4e22cf4
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium and Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-01
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 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 with Laxative
Listing expiration
2026-12-31

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
e24638d3-7738-4185-8ce9-1845d8594cc6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2522-1Stool Softener with Laxative30 in 1 BOTTLETABLET, FILM COATED301
71335-2522-2Stool Softener with Laxative120 in 1 BOTTLETABLET, FILM COATED1201
71335-2522-3Stool Softener with Laxative60 in 1 BOTTLETABLET, FILM COATED601
71335-2522-4Stool Softener with Laxative90 in 1 BOTTLETABLET, FILM COATED901
71335-2522-5Stool Softener with Laxative100 in 1 BOTTLETABLET, FILM COATED1001
71335-2522-6Stool Softener with Laxative28 in 1 BOTTLETABLET, FILM COATED281
71335-2522-7Stool Softener with Laxative56 in 1 BOTTLETABLET, FILM COATED561
71335-2522-8Stool Softener with Laxative14 in 1 BOTTLETABLET, FILM COATED141
71335-2522-9Stool Softener with Laxative20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2522STOOL SOFTENER WITH LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 9 package rows20241105_e24638d3-7738-4185-8ce9-1845d8594cc6.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 SENNOSIDESBryant Ranch Prepacke24638d3-7738-4185-8ce9-1845d8594cc62024-11-04WarningsExact identifier
ndc (package): 71335-2522-2
ndc (product): 71335-2522
ndc11 (package): 71335252202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
71335-2522-271335252202120 TABLET, FILM COATED in 1 BOTTLE (71335-2522-2) 2024-11-04NoNoCurrent