Senna Plus
gc 455t (458)
Approved
Approval ID
616a896a-d238-7f7c-e053-2a91aa0a0f5b
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
Geri-Care Pharmaceutical Corp
DUNS: 611196254
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sennosides and Docusate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57896-458
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sennosides and Docusate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (21)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
DOCUSATE SODIUMActive
Quantity: 50 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT