FDA.reportPublic FDA data

Senna Laxative

Product NDC
84324-012
11-digit product format
843240012
Labeler code
84324
Product ID
84324-012_bfbd8b84-7865-457a-9693-c2b2fef5411b
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides 8.6 mg
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-17
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
Senna 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
372e8b67-2b9a-4416-b6c2-f44fd24f35e9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-012-01Senna Laxative200 in 1 BOTTLETABLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-012SENNA LAXATIVE (SENNOSIDES 8.6 MG) TABLET [NUVICARE LLC]2Current NDC, 1 package rows20250227_372e8b67-2b9a-4416-b6c2-f44fd24f35e9.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 LaxativeSENNOSIDES 8.6 MGNUVICARE LLC372e8b67-2b9a-4416-b6c2-f44fd24f35e92025-02-20WarningsExact identifier
ndc (product): 84324-012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSN372e8b67-2b9a-4416-b6c2-f44fd24f35e92
312935sennosides, USP 8.6 MG Oral TabletSCD372e8b67-2b9a-4416-b6c2-f44fd24f35e92
312935sennosides A and B 8.6 MG Oral TabletSY372e8b67-2b9a-4416-b6c2-f44fd24f35e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84324-012-0184324001201200 TABLET in 1 BOTTLE (84324-012-01) 200 tablet2024-07-17NoNoCurrent