FDA.reportPublic FDA data

Senna Syrup

Product NDC
54859-808
11-digit product format
548590808
Labeler code
54859
Product ID
54859-808_471f34fb-ff03-54f3-e063-6394a90afacc
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
LIQUID
Route
ORAL
Labeler
Llorens Pharmaceutical International Division, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-01
Substance
SENNOSIDES
Active strength
8.8 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Syrup
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.8 mg/5mL

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
702311Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5be0163c-b7f7-46db-b738-78c2946a6cf6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-808-08Senna Syrup237 mL in 1 BOTTLELIQUID2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-808-08ML - Milliliter54859-808b7229fb6-73e6-4981-a025-f958cb6549ee12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-808SENNA SYRUP (SENNOSIDES) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.]5Current NDC, Legacy NDC, 1 package rows20241225_5be0163c-b7f7-46db-b738-78c2946a6cf6.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 35 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack2c9a1fe7-b77b-436b-8701-9f95f642d0012024-07-05WarningsExact identifier
application number: M007
SENNASENNAPrecision Dose, Inc.e637777e-a39d-4e2f-a95c-4f524aa122f72024-07-05WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEGERI-CARE PHARMACEUTICALS, CORP1c462af8-af1a-391c-e063-6394a90a8b492024-07-02WarningsExact identifier
application number: M007
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant FreeCALCIUM POLYCARBOPHILAmerisourcebergen Drug Corporation4911fb44-e070-46c1-8f90-b78ceb10e51e2024-06-28WarningsExact identifier
application number: M007
FleetDOCUSATE SODIUMC.B. Fleet Company, Inc.56a7b6c5-d674-4eed-91c2-77f7d18fff322024-06-27WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMWALMART INC. (see also Equate)2cf6c9bf-c318-445d-9306-5675b1d424b02024-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWALMART INC. (see also Equate)d9db24b5-e3b5-47f9-b86b-bc8d70896a112024-06-26WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreens2791223a-7ac0-47e5-9a6a-4d9a02cfeb632024-06-25WarningsExact identifier
application number: M007
FleetBISACODYLC.B. Fleet Company, Inc.4e0d973f-e6dc-48d9-8df3-1d47c87840f12024-06-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESTOP CARE (Topco Associates LLC)3b184800-649b-45d0-9586-8055d6d7fe082024-06-20WarningsExact identifier
application number: M007
Senna LaxativeSENNA LAXATIVEGood Sense9393032e-4343-4ac5-8e91-36013e5ca0892024-06-18WarningsExact identifier
application number: M007
Stool SoftenerSTOOL SOFTENERGood Sense64266195-1b07-42c2-98a7-d76c12f747762024-06-18WarningsExact identifier
application number: M007
Stool Softener Plus StimulantDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI6c8c7c46-3ded-4e89-8e16-30eeb72aa08b2024-06-14WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI50ca1ce2-885f-4b71-a5fb-90c2cf508ce62024-06-14WarningsExact identifier
application number: M007
basic care stool softenerDOCUSATE SODIUMAmazon.com Services LLC356a889f-ec23-4eb2-a25c-bbe6094751552024-06-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI88cc2575-27a1-4514-bc41-bd1eac2838142024-06-13WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI2b5e1f03-0182-4d1c-8ba0-b1008b1335ad2024-06-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation1b7edd67-7b14-4fdd-9821-637f4b3c3a2c2024-06-06WarningsExact identifier
application number: M007
SennaSENNOSIDESPatrin Pharma, Inc.a9f1ef8d-8700-481f-a709-972bb9d271532024-05-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5f9cd233-6c46-5b52-e053-2991aa0ab7292024-05-23WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN5be0163c-b7f7-46db-b738-78c2946a6cf66
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD5be0163c-b7f7-46db-b738-78c2946a6cf66
702311sennosides 8.8 MG per 5 mL Oral SyrupSY5be0163c-b7f7-46db-b738-78c2946a6cf66
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY5be0163c-b7f7-46db-b738-78c2946a6cf66
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY5be0163c-b7f7-46db-b738-78c2946a6cf66
702311sennosides 8.8 MG in 5 mL Oral SolutionPSNe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef634
702311sennosides, USP 1.76 MG/ML Oral SolutionSCDe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef634
702311sennosides 8.8 MG per 5 mL Oral SyrupSYe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef634
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSYe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef634
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSYe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-808-0854859080808237 mL in 1 BOTTLE (54859-808-08) 237 ml2019-05-010000-00-00NoNoCurrent