FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
41163-755
Requested package NDC
41163-755-10
11-digit product format
411630755
Labeler code
41163
Product ID
41163-755_d2f24eb9-8b0e-459f-81df-3e9dd9fd3ce3
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
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

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
db15be6e-9ac6-4cf9-89f8-14480c89fcd2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-755-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-755STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 1 package rows20240906_db15be6e-9ac6-4cf9-89f8-14480c89fcd2.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 SENNOSIDESUnited Natural Foods, Inc. dba UNFIdb15be6e-9ac6-4cf9-89f8-14480c89fcd22024-09-04WarningsExact identifier
ndc (package): 41163-755-10
ndc (product): 41163-755
ndc11 (package): 41163075510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNdb15be6e-9ac6-4cf9-89f8-14480c89fcd24
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDdb15be6e-9ac6-4cf9-89f8-14480c89fcd24
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYdb15be6e-9ac6-4cf9-89f8-14480c89fcd24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-755-1041163075510100 TABLET in 1 BOTTLE, PLASTIC (41163-755-10) 100 tablet2021-04-300000-00-00NoNoCurrent