FDA.reportPublic FDA data

Laxative

Product NDC
55910-454
11-digit product format
559100454
Labeler code
55910
Product ID
55910-454_6f3391b8-9edc-4c8e-ac3a-2dcc3623e777
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-23
Substance
SENNOSIDES
Active strength
25 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
Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES25 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
251292Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a476afb-ad61-4934-97e4-a0e28a97f6c9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-454-08Laxative12 in 1 BLISTER PACKTABLET, FILM COATED125
55910-454-08Laxative2 in 1 CARTONTABLET, FILM COATED25
55910-454-22Laxative4 in 1 CARTONTABLET, FILM COATED45
55910-454-22Laxative12 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-454LAXATIVE (SENNOSIDES) TABLET, FILM COATED [DOLGENCORP, LLC]4Current NDC, 4 package rows20240623_5a476afb-ad61-4934-97e4-a0e28a97f6c9.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
LaxativeSENNOSIDESDOLGENCORP, LLC5a476afb-ad61-4934-97e4-a0e28a97f6c92026-06-24WarningsExact identifier
ndc (product): 55910-454

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251292sennosides 25 MG Oral TabletPSN5a476afb-ad61-4934-97e4-a0e28a97f6c95
251292sennosides, USP 25 MG Oral TabletSCD5a476afb-ad61-4934-97e4-a0e28a97f6c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-454-08559100454082 BLISTER PACK in 1 CARTON (55910-454-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-02-23NoNoCurrent
55910-454-22559100454224 BLISTER PACK in 1 CARTON (55910-454-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2023-02-23NoNoCurrent