FDA.reportPublic FDA data

Senna Laxative

Product NDC
70677-1097
11-digit product format
706771097
Labeler code
70677
Product ID
70677-1097_d4f98320-15c5-417a-b854-97f18bccf85b
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-31
Substance
SENNOSIDES
Active strength
8.6 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
Senna Laxative
Listing expiration
2027-12-31

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
7143bf46-4461-432e-86f7-47f1ad488bfaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1097-1Senna Laxative100 in 1 BOTTLE, PLASTICTABLET1003
70677-1097-1Senna Laxative1 in 1 BOXTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1097-1EA - Each70677-10974f7275d1-9e9b-45e0-b92f-b012e13265b212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1097SENNA LAXATIVE (SENNOSIDES) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20240709_7143bf46-4461-432e-86f7-47f1ad488bfa.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 LaxativeSENNOSIDESStrategic Sourcing Services LLC7143bf46-4461-432e-86f7-47f1ad488bfa2024-07-08WarningsExact identifier
ndc (product): 70677-1097

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSN7143bf46-4461-432e-86f7-47f1ad488bfa3
312935sennosides, USP 8.6 MG Oral TabletSCD7143bf46-4461-432e-86f7-47f1ad488bfa3
312935sennosides A and B 8.6 MG Oral TabletSY7143bf46-4461-432e-86f7-47f1ad488bfa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70677-1097-1706771097011 BOTTLE, PLASTIC in 1 BOX (70677-1097-1) / 100 TABLET in 1 BOTTLE, PLASTIC2023-03-31NoNoCurrent