FDA.reportPublic FDA data

Laxative

Product NDC
55319-773
11-digit product format
553190773
Labeler code
55319
Product ID
55319-773_b3a4e5eb-77b8-44ee-809b-1fea4906b362
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Family Dollar Services Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-09
Substance
SENNOSIDES
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
e220ac72-6dba-4c56-b5be-5e238d0a4598Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-773-08Laxative2 in 1 CARTONTABLET, FILM COATED24
55319-773-08Laxative12 in 1 BLISTER PACKTABLET, FILM COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-773LAXATIVE (SENNOSIDES) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC]3Current NDC, 2 package rows20250217_e220ac72-6dba-4c56-b5be-5e238d0a4598.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
LaxativeSENNOSIDESFamily Dollar Services Ince220ac72-6dba-4c56-b5be-5e238d0a45982026-02-02WarningsExact identifier
ndc (product): 55319-773

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251292sennosides 25 MG Oral TabletPSNe220ac72-6dba-4c56-b5be-5e238d0a45984
251292sennosides, USP 25 MG Oral TabletSCDe220ac72-6dba-4c56-b5be-5e238d0a45984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-773-08553190773082 BLISTER PACK in 1 CARTON (55319-773-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-02-09NoNoCurrent