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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEMethod Pharmaceuticalsce83ba78-7e0d-b37f-e053-2995a90a93832025-10-21WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
application number: M007
Senna SyrupSENNA SYRUPKesin Pharma Corporation360fb98d-c6ad-7bcc-e063-6294a90a94532025-10-14WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
application number: M007
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
application number: M007
Castor OilCASTOR OILBIONPHARMA INC.3f9728e8-c7a2-6cfb-e063-6394a90a8f1d2025-10-06WarningsExact identifier
application number: M007
SennosidesSENNOSIDESInvaTech Pharma Solutions LLC3de39fbd-29be-fce7-e063-6394a90a67ae2025-10-03WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKThe Procter & Gamble Manufacturing Companya9824f73-5ea2-4a65-a926-3a57561441b82025-10-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAtlantic Biologicals Corp.40202c76-4273-88fd-e063-6394a90a07b22025-10-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONBionpharma, Inc.4019fbd0-fcf9-77a6-e063-6294a90a5ae72025-09-30WarningsExact identifier
application number: M007
LEADER HYDROCORTISONE WITH ALOEHYDROCORTISONELEADER39916470-15bf-4bd0-96e2-b909d68cf9c42025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKesin Pharma Corporation3f7cff50-749b-5275-e063-6394a90af4072025-09-23WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGBryant Ranch Prepack12f613e4-c919-4cc4-a445-eb30039ae45f2025-09-18WarningsExact identifier
application number: M007
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
application number: M007
Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f29d57f6-0938-d459-e053-2995a90ad86b2025-09-13WarningsExact 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