Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen
Product Details
NDC Product Code
69842-491Application Number
M013Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
May 2, 2025D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 500 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT