FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0363-8550
11-digit product format
003638550
Labeler code
0363
Product ID
0363-8550_2e5d5bac-b7f9-44c5-a618-3c8bbe6adfc0
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-30
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2027-12-31

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
cd668027-fb64-4e7d-86a5-2f0261599ae9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8550-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICTABLET2009
0363-8550-60Stool Softener Laxative60 in 1 BOTTLETABLET609
0363-8550-60Stool Softener Laxative1 in 1 BOXTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8550STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [WALGREENS]7Current NDC, Legacy NDC, 3 package rows20240910_cd668027-fb64-4e7d-86a5-2f0261599ae9.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 SENNOSIDESWalgreenscd668027-fb64-4e7d-86a5-2f0261599ae92026-04-17WarningsExact identifier
ndc (product): 0363-8550

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNcd668027-fb64-4e7d-86a5-2f0261599ae99
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDcd668027-fb64-4e7d-86a5-2f0261599ae99
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYcd668027-fb64-4e7d-86a5-2f0261599ae99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8550-2000363855020200 TABLET in 1 BOTTLE, PLASTIC (0363-8550-20) 200 tablet2020-07-300000-00-00NoNoCurrent
0363-8550-60003638550601 BOTTLE in 1 BOX (0363-8550-60) / 60 TABLET in 1 BOTTLE1 bottle2020-07-300000-00-00NoNoCurrent