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 26 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f2c4ed1a-5aa4-1915-e053-2a95a90a59b62025-02-12WarningsExact identifier
application number: M007
LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c5c1e6-3123-c802-e053-2995a90aa0732025-02-12WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c529e4-6738-377c-e053-2995a90aaf382025-02-12WarningsExact identifier
application number: M007
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCVS HEALTHb05ee52f-4801-d4ca-e053-2995a90af3482025-02-12WarningsExact identifier
application number: M007
SENNASENNOSIDESReliable 1 Laboratories LLCc8aa7ae9-7d00-db7d-e053-2995a90ae72b2025-02-11WarningsExact identifier
application number: M007
Extra Gentle LaxativeBISACODYLDOLGENCORP INCbe214c4e-f6db-cc8d-e053-2a95a90addf72025-02-10WarningsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESKROGERa187045c-c9d6-592a-e053-2995a90adb832025-02-10WarningsExact identifier
application number: M007
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
application number: M007
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
application number: M007
LAX-TIMESENNOSIDESTIME CAP LABORATORIES, INC74a627fc-00e5-eb78-e053-2991aa0abacc2025-02-08WarningsExact identifier
application number: M007
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESTIME CAP LABORATORIES, INC7498f5fa-1739-bb6e-e053-2a91aa0a54042025-02-07WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALMART INC.26b9f247-c242-2925-e063-6394a90a68dd2025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
application number: M007
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
application number: M007
LaxativeSENNOSIDESWALGREENSf0caba1d-0c09-8496-e053-2995a90a47cf2025-01-30WarningsExact 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