FDA.reportPublic FDA data

Senna

Product NDC
0121-4967
11-digit product format
001214967
Labeler code
0121
Product ID
0121-4967_788bfeed-afae-42ae-a24b-0634f35f000b
Type
HUMAN OTC DRUG
Nonproprietary name
sennosides
Dosage form
LIQUID
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-22
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
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
7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6edAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4967-05Senna5 mL in 1 CUP, UNIT-DOSELIQUID57
0121-4967-40Senna10 in 1 TRAYLIQUID107
0121-4967-40Senna4 in 1 CASELIQUID47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4967-05ML - Milliliter0121-4967967b07b3-40f5-45ac-891a-3431f314666012022-04-06
0121-4967-40ML - Milliliter0121-4967772566ca-c6fd-45fe-bcca-75122be4955d12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4967SENNA (SENNOSIDES) LIQUID [PAI HOLDINGS, LLC DBA PAI PHARMA]7Current NDC, Legacy NDC, 3 package rows20250429_7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed.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 37 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation89106733-69f1-469b-9d07-f06ac09b2fb62024-04-02WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.e0b7acab-add4-4daf-b1df-bb7cf5ca8e192024-04-01WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2322765d-6f08-48d4-a500-818a8a558f6f2024-03-19WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)dcab26ff-2c10-4478-90a8-c89d87261bfa2024-03-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4d1391da-7874-4a51-a468-2843ecf6f92b2024-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)adaea845-e029-422d-a947-d8ce8f5787ed2024-03-18WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC62544c2f-6e30-4cec-ae63-233715ef06992024-03-13WarningsExact identifier
application number: M007
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE CALCIUMCVS Pharmacycf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy8d59fa14-fc7c-4146-ba59-c2a907356dd62024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCostco Wholesalea19c20bd-84ff-4931-8312-2fbf0400e8e02024-03-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)a1ea0993-2d23-44e3-bc72-e4bf497ab7232024-03-05WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESCare One (Retail Business Services, LLC.)a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f2024-03-05WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed7
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed7
702311sennosides 8.8 MG per 5 mL Oral SyrupSY7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed7
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed7
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4967-05001214967055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-4967-40001214967404 TRAY in 1 CASE (0121-4967-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4967-05) 4 tray2022-03-220000-00-00NoNoCurrent