Laxative

Product NDC
76162-773
11-digit product format
761620773
Labeler code
76162
Product ID
76162-773_027889ff-ef62-4097-a5ff-8f16ce3250b7
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-18
Substance
SENNOSIDES
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
3392b38e-f6d7-425e-8991-a4315b0bca75Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-773-08Laxative12 in 1 BLISTER PACKTABLET, FILM COATED125
76162-773-08Laxative2 in 1 CARTONTABLET, FILM COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-773LAXATIVE (SENNOSIDES) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20240623_3392b38e-f6d7-425e-8991-a4315b0bca75.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
LaxativeSENNOSIDESTOPCO ASSOCIATES LLC3392b38e-f6d7-425e-8991-a4315b0bca752026-06-17WarningsExact identifier
ndc (product): 76162-773

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251292sennosides 25 MG Oral TabletPSN3392b38e-f6d7-425e-8991-a4315b0bca755
251292sennosides, USP 25 MG Oral TabletSCD3392b38e-f6d7-425e-8991-a4315b0bca755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-773-08761620773082 BLISTER PACK in 1 CARTON (76162-773-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2022-06-180000-00-00NoNoCurrent