FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
46122-669
11-digit product format
461220669
Labeler code
46122
Product ID
46122-669_ca2d11e2-1eae-46bc-91fe-457cb8aa2297
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-26
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

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
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
7e573645-b156-4768-8e69-00998f508073Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-669-78Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-669-78EA - Each46122-669fc30dc90-72ae-4511-a461-28de7c85805112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-669STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]5Current NDC, Legacy NDC, 1 package rows20240907_7e573645-b156-4768-8e69-00998f508073.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 SENNOSIDESAmerisourceBergen (Good Neighbor Pharmacy) 461227e573645-b156-4768-8e69-00998f5080732024-09-06WarningsExact identifier
ndc (product): 46122-669

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN7e573645-b156-4768-8e69-00998f5080735
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD7e573645-b156-4768-8e69-00998f5080735
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY7e573645-b156-4768-8e69-00998f5080735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-669-7846122066978100 TABLET in 1 BOTTLE, PLASTIC (46122-669-78) 100 tablet2021-03-260000-00-00NoNoCurrent