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FDA Approval

Senna-S

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

FDA Approval Summary

Company
Meijer, Inc.
DUNS: 006959555
Effective Date
March 24, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Sennosides(8.6 mg in 1 1)
Docusate(50 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Geri-Care Pharmaceutical Corp

611196254

Products1

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

Senna-S

Product Details

NDC Product Code
79481-0555
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
March 24, 2025
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: 3FYP5M0IJXClass: ACTIBQuantity: 8.6 mg in 1 1
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 50 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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