FDA.reportPublic FDA data

SENNA

Product NDC
68094-049
11-digit product format
680940049
Labeler code
68094
Product ID
68094-049_e6e1ea89-0223-4a05-915a-77ec0d923815
Type
HUMAN OTC DRUG
Nonproprietary name
SENNA
Dosage form
SYRUP
Route
ORAL
Labeler
Precision Dose, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-15
Substance
SENNOSIDES A AND B
Active strength
417.12 mg/237mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES A AND B417.12 mg/237mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1B5FPI42ENInternal 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
e637777e-a39d-4e2f-a95c-4f524aa122f7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-049-59SENNA5 mL in 1 CUP, UNIT-DOSESYRUP52
68094-049-62SENNA10 in 1 TRAYSYRUP102
68094-049-62SENNA3 in 1 CASESYRUP32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-049-59ML - Milliliter68094-0499dbeca0f-1691-42f6-b5fc-481082a6764912024-07-12
68094-049-62ML - Milliliter68094-049be2c8753-1fd8-4128-bf2f-ce768e81088b12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-049SENNA SYRUP [PRECISION DOSE, INC.]2Current NDC, 3 package rows20240719_e637777e-a39d-4e2f-a95c-4f524aa122f7.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 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 SolutionPSNe637777e-a39d-4e2f-a95c-4f524aa122f72
702311sennosides, USP 1.76 MG/ML Oral SolutionSCDe637777e-a39d-4e2f-a95c-4f524aa122f72
702311sennosides 8.8 MG per 5 mL Oral SyrupSYe637777e-a39d-4e2f-a95c-4f524aa122f72
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSYe637777e-a39d-4e2f-a95c-4f524aa122f72
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSYe637777e-a39d-4e2f-a95c-4f524aa122f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-049-59680940049595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-049-62680940049623 TRAY in 1 CASE (68094-049-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-049-59) 3 tray2024-06-15NoNoCurrent