FDA.reportPublic FDA data

Stool Softener

Product NDC
72476-855
11-digit product format
724760855
Labeler code
72476
Product ID
72476-855_534f880e-9723-427d-8841-6817c4f3a8ef
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Care One (Retail Business Services, LLC.)
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

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener
Brand name suffix
Plus Stimulant 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
7f4f7fcb-5202-4184-80ef-b4b6c6460c2fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-855-10Stool SoftenerPlus Stimulant Laxative1 in 1 BOXTABLET14
72476-855-10Stool SoftenerPlus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-855STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]4Current NDC, Legacy NDC, 2 package rows20240906_7f4f7fcb-5202-4184-80ef-b4b6c6460c2f.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 Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)7f4f7fcb-5202-4184-80ef-b4b6c6460c2f2024-09-04WarningsExact identifier
ndc (product): 72476-855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN7f4f7fcb-5202-4184-80ef-b4b6c6460c2f4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD7f4f7fcb-5202-4184-80ef-b4b6c6460c2f4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY7f4f7fcb-5202-4184-80ef-b4b6c6460c2f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-855-10724760855101 BOTTLE, PLASTIC in 1 BOX (72476-855-10) / 100 TABLET in 1 BOTTLE, PLASTIC2020-06-300000-00-00NoNoCurrent