MedPath
FDA Approval

Senna

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Sennosides(8.8 mg in 5 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma

PAI Holdings, LLC dba PAI Pharma

097630693

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Senna

Product Details

NDC Product Code
0121-4967
Application Number
M007
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
April 28, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
Code: 3FYP5M0IJXClass: ACTIBQuantity: 8.8 mg in 5 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
CITRIC ACID ACETATEInactive
Code: DSO12WL7AUClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
© Copyright 2025. All Rights Reserved by MedPath