FDA.reportPublic FDA data

SENNA Syrup

Product NDC
66424-562
11-digit product format
664240562
Labeler code
66424
Product ID
66424-562_29bbb628-c28a-9fbe-e063-6294a90a7a8b
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides A and B
Dosage form
SYRUP
Route
ORAL
Labeler
SDA Laboratories, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
Substance
SENNOSIDES A AND B
Active strength
8.8 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES A AND B8.8 mg/5mL

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
cfc6ab2f-5376-46fc-ac58-7dedd7010006Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66424-562-082021-03-15C16284748780-1ba0f9c33-1476-a910-e053-dadaa90a0b85SDA- Senna 562
66424-562-082021-01-29C16284748780-1ba0f9c33-1476-a910-e053-dadaa90a0b85SDA- Senna 562

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-562-08SENNA Syrup236 mL in 1 BOTTLE, PLASTICSYRUP2367

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-562-08ML - Milliliter66424-56252ad75f8-e737-4df9-b05c-3ca9cf29bbed12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-562SENNA SYRUP (SENNOSIDES A AND B) SYRUP [SDA LABORATORIES, INC.]7Current NDC, Legacy NDC, 1 package rows20241222_cfc6ab2f-5376-46fc-ac58-7dedd7010006.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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
application number: M007
Rite Aid Fiber TherapyMETHYLCELLULOSERITE AID CORPORATIONe50cea80-c020-4b85-b61f-d053f11f479b2024-10-30WarningsExact identifier
application number: M007
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
application number: M007
Premier Value Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC2d580965-2bef-46ee-8532-fbe34330a4b42024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Original CoarsePSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC8c85a13d-ae99-4599-9a28-c3965caa63762024-10-28WarningsExact identifier
application number: M007
Premier ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
application number: M007
Premier Value FiberPSYLLIUM HUSKChain Drug Consortium, LLCc507fe4a-1f8e-4780-a2f5-9da6e5922bef2024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC85651bd7-e959-4455-a5ed-bd0223ce05632024-10-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporationf7309f4a-f1f5-420e-bfc7-fb4495a5afba2024-10-24WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation2540ae39-2218-0f6a-e063-6294a90a5efc2024-10-24WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
application number: M007
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
application number: M007
NATURAL Epsom SaltMAGNESIUM SULFATEUniversal Distribution Center LLCb2682e51-ffa4-4556-b2a6-b0dbd543fd4f2024-10-16WarningsExact identifier
application number: M007
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
application number: M007
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
application number: M007
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSNcfc6ab2f-5376-46fc-ac58-7dedd70100067
702311sennosides, USP 1.76 MG/ML Oral SolutionSCDcfc6ab2f-5376-46fc-ac58-7dedd70100067
702311sennosides 8.8 MG per 5 mL Oral SyrupSYcfc6ab2f-5376-46fc-ac58-7dedd70100067
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSYcfc6ab2f-5376-46fc-ac58-7dedd70100067
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSYcfc6ab2f-5376-46fc-ac58-7dedd70100067

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66424-562-0866424056208236 mL in 1 BOTTLE, PLASTIC (66424-562-08) 236 ml2015-01-010000-00-00NoNoCurrent