FDA.reportPublic FDA data

Senna Syrup

Product NDC
81033-120
11-digit product format
810330120
Labeler code
81033
Product ID
81033-120_4124d2ca-847d-bb50-e063-6294a90af8f0
Type
HUMAN OTC DRUG
Nonproprietary name
Senna Syrup
Dosage form
SYRUP
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-26
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
360fb98d-c6ad-7bcc-e063-6294a90a9453Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-120-05Senna Syrup5 mL in 1 CUP, UNIT-DOSESYRUP52
81033-120-10Senna Syrup10 mL in 1 CUP, UNIT-DOSESYRUP102
81033-120-15Senna Syrup15 mL in 1 CUP, UNIT-DOSESYRUP152
81033-120-50Senna Syrup50 in 1 CARTONSYRUP502
81033-120-54Senna Syrup50 in 1 CARTONSYRUP502
81033-120-55Senna Syrup50 in 1 CARTONSYRUP502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-120-05ML - Milliliter81033-1200e75bf43-dba6-48c5-8017-4de9486dbf4712025-07-08
81033-120-10ML - Milliliter81033-120478b4a61-8b55-4a29-8fca-bd0d9d0b556c12025-12-16
81033-120-15ML - Milliliter81033-1203642f0b3-e8fb-4663-b2ad-951b82fba92412025-12-16
81033-120-50ML - Milliliter81033-120398d5ce8-fc9e-4655-adc4-04a63e839a2112025-07-08
81033-120-54ML - Milliliter81033-120db9146a1-1943-4e6f-9a2d-f25d8a6e2fe512025-12-16
81033-120-55ML - Milliliter81033-120ad25a372-98bb-42ed-9858-bb45610f814d12025-12-16

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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN360fb98d-c6ad-7bcc-e063-6294a90a94532
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD360fb98d-c6ad-7bcc-e063-6294a90a94532
702311sennosides 8.8 MG per 5 mL Oral SyrupSY360fb98d-c6ad-7bcc-e063-6294a90a94532
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY360fb98d-c6ad-7bcc-e063-6294a90a94532
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY360fb98d-c6ad-7bcc-e063-6294a90a94532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-120-05810330120055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-120-108103301201010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
81033-120-158103301201515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
81033-120-508103301205050 CUP, UNIT-DOSE in 1 CARTON (81033-120-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-120-05) 2025-05-26NoNoCurrent
81033-120-548103301205450 CUP, UNIT-DOSE in 1 CARTON (81033-120-54) / 10 mL in 1 CUP, UNIT-DOSE (81033-120-10) 2025-10-20NoNoCurrent
81033-120-558103301205550 CUP, UNIT-DOSE in 1 CARTON (81033-120-55) / 15 mL in 1 CUP, UNIT-DOSE (81033-120-15) 2025-10-20NoNoCurrent