FDA.reportPublic FDA data

Vegetable Laxative

Product NDC
63561-0188
11-digit product format
635610188
Labeler code
63561
Product ID
63561-0188_3b297015-438b-9914-e063-6294a90adc3a
Type
HUMAN OTC DRUG
Nonproprietary name
SENNOSIDES, 8.6 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granulation Technology, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-11
Substance
SENNOSIDES
Active strength
8.6 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
Vegetable Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312935Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63dfe908-7cc0-41ca-9739-4b24ee14648eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0188-1Vegetable Laxative100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
63561-0188-2Vegetable Laxative1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0188VEGETABLE LAXATIVE (SENNOSIDES, 8.6 MG) TABLET, FILM COATED [GRANULATION TECHNOLOGY, INC.]1Current NDC, 2 package rows20241219_63dfe908-7cc0-41ca-9739-4b24ee14648e.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
Vegetable LaxativeSENNOSIDES, 8.6 MGGranulation Technology, Inc.63dfe908-7cc0-41ca-9739-4b24ee14648e2025-07-30WarningsExact identifier
ndc (product): 63561-0188

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSN63dfe908-7cc0-41ca-9739-4b24ee14648e4
312935sennosides, USP 8.6 MG Oral TabletSCD63dfe908-7cc0-41ca-9739-4b24ee14648e4
312935sennosides A and B 8.6 MG Oral TabletSY63dfe908-7cc0-41ca-9739-4b24ee14648e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63561-0188-163561018801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63561-0188-1) 2025-06-11NoNoCurrent
63561-0188-2635610188021000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63561-0188-2) 2025-07-29NoNoCurrent