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FDA Approval

Advil Allergy and Congestion Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Haleon US Holdings LLC
DUNS: 079944263
Effective Date
April 9, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Chlorpheniramine(4 mg in 1 1)
Ibuprofen(200 mg in 1 1)
Phenylephrine(10 mg in 1 1)

Products2

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

Advil Allergy and Congestion Relief

Product Details

NDC Product Code
0573-2161
Application Number
NDA022113
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
April 9, 2025
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
Code: V1Q0O9OJ9ZClass: ACTIBQuantity: 4 mg in 1 1
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 200 mg in 1 1
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 1
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGVClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92Class: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT

Advil Allergy and Congestion Relief

Product Details

NDC Product Code
0573-0196
Application Number
NDA022113
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
April 9, 2025
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: V1Q0O9OJ9ZClass: ACTIBQuantity: 4 mg in 1 1
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 200 mg in 1 1
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGVClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92Class: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
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