Stool Softener Laxative

Product NDC
21130-855
11-digit product format
211300855
Labeler code
21130
Product ID
21130-855_bdbb155b-4855-4aeb-9793-881222b59023
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Safeway, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-29
Marketing end
2027-02-28
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 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
ae2c7300-f9c4-43b5-9f8e-30f2e7d17635Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-855-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICTABLET2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-855STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [SAFEWAY, INC.]4Current NDC, Legacy NDC, 1 package rows20240910_ae2c7300-f9c4-43b5-9f8e-30f2e7d17635.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 SENNOSIDESSafeway, Inc.ae2c7300-f9c4-43b5-9f8e-30f2e7d176352026-08-19WarningsExact identifier
ndc (product): 21130-855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNae2c7300-f9c4-43b5-9f8e-30f2e7d176354
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDae2c7300-f9c4-43b5-9f8e-30f2e7d176354
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYae2c7300-f9c4-43b5-9f8e-30f2e7d176354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-855-2021130085520200 TABLET in 1 BOTTLE, PLASTIC (21130-855-20) 200 tablet2021-01-292027-02-28NoNoCurrent