Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LNK International, Inc.
Walgreen Company
967626305
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cold, Flu and Sore Throat
Product Details
NDC Product Code
0363-8005Application Number
M012Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
April 25, 2025AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 650 mg in 20 mL
DextromethorphanActive
Code: 9D2RTI9KYHClass: ACTIBQuantity: 20 mg in 20 mL
GuaifenesinActive
Code: 495W7451VQClass: ACTIBQuantity: 400 mg in 20 mL
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 20 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT