Sleep Aid

Products1

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

NDC Product Code

49580-0314

Application Number

M010

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

ORAL

Effective Date

March 24, 2025

Ingredients

Code: TC2D6JAD40Class: ACTIBQuantity: 50 mg in 30 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SACCHARIN SODIUM ANHYDROUSInactive

Code: I4807BK602Class: IACT

HIGH FRUCTOSE CORN SYRUPInactive

Code: XY6UN3QB6SClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYOXYL 40 STEARATE TYPE IInactive

Code: 13A4J4NH9IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT