FDA.reportPublic FDA data

Senna-S

Product NDC
63561-0187
11-digit product format
635610187
Labeler code
63561
Product ID
63561-0187_3b28e1ec-d284-2f66-e063-6294a90aa7f1
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM, SENNOSIDES
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granulation Technology, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-29
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
Senna-S
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES50 mg/1
DOCUSATE SODIUM8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup
F05Q2T2JA0Internal 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
f36c509e-b93b-4d7f-a18a-41e585369a15Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0187-1Senna-S100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
63561-0187-2Senna-S220 in 1 BOTTLE, PLASTICTABLET, FILM COATED2204
63561-0187-3Senna-S1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0187SENNA-S (DOCUSATE SODIUM, SENNOSIDES) TABLET, FILM COATED [GRANULATION TECHNOLOGY, INC.]1Current NDC, 3 package rows20241127_f36c509e-b93b-4d7f-a18a-41e585369a15.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
Senna-SDOCUSATE SODIUM, SENNOSIDESGranulation Technology, Inc.f36c509e-b93b-4d7f-a18a-41e585369a152025-07-30WarningsExact identifier
ndc (product): 63561-0187

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNf36c509e-b93b-4d7f-a18a-41e585369a154
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDf36c509e-b93b-4d7f-a18a-41e585369a154
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYf36c509e-b93b-4d7f-a18a-41e585369a154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63561-0187-163561018701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63561-0187-1) 2025-07-29NoNoCurrent
63561-0187-263561018702220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63561-0187-2) 2025-07-29NoNoCurrent
63561-0187-3635610187031000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63561-0187-3) 2025-07-29NoNoCurrent