Acetaminophen

Registrants1

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

DUNS Number

119032580

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

NDC Product Code

83720-500

Application Number

M013

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

ORAL

Effective Date

April 28, 2025

Ingredients

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

Code: 362O9ITL9DClass: ACTIBQuantity: 160 mg in 5 mL