RIGHT REMEDIES OVERNIGHT Laxative
OVERNIGHT Laxative BISACODYL (USP) 5 mg
Approved
Approval ID
322beeab-cdff-3a31-e063-6294a90a0c52
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 25, 2025
Manufacturers
FDA
Strive Pharmaceuticals Inc.
DUNS: 080028013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisacodyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70692-761
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bisacodyl
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (24)
BISACODYLActive
Quantity: 5 mg in 1 1
Code: 10X0709Y6I
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9N
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT