Gentle Overnight Laxative

Manufacturing Establishments1

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

LNK International, Inc.

Labeler

Better Living Brands, LLC

DUNS Number

117025878

Products1

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

Product Details

NDC Product Code

21130-827

Application Number

505G(a)(3)

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

ORAL

Effective Date

April 29, 2025

Ingredients

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGKClass: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C YELLOW NO. 6 ALUMINUM LAKEInactive

Code: GYP6Z2JR6QClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IEClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Polyvinyl Acetate PhthalateInactive

Code: 58QVG85GW3Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1OClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM ALGINATEInactive

Code: C269C4G2ZQClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

BisacodylActive

Code: 10X0709Y6IClass: ACTIBQuantity: 5 mg in 1 1

ACACIAInactive

Code: 5C5403N26OClass: IACT

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Gentle Overnight Laxative

FDA Approval Summary

Manufacturing Establishments1

Products1

Gentle Overnight Laxative

Product Details