FDA.reportPublic FDA data

Application 022565

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL CONGESTION RELIEFIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDETABLET;ORAL200MG;10MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022565-001ADVIL CONGESTION RELIEFIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORALRLD, RS2010-05-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL SINUS CONGESTION AND PAINIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf2025-07-22WarningsExact identifier
application applno (NDA): 022565
application number: NDA022565
ndc (product): 0573-0199
Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.531abadc-37fd-4953-95bc-a211a2ba69142023-03-15WarningsExact identifier
application applno (NDA): 022565
application number: NDA022565
ndc (product): 67751-150

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
52904-782Advil Sinus Congestion and Painibuprofen, phenylephrine hydrochlorideSelect CorporationNDACurrent
67751-150Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.NDACurrent
67751-150Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69402SUPPL2021-11-23
69382SUPPL2021-11-23
64158SUPPL2020-07-31
64157SUPPL2020-07-31
59302SUPPL2019-07-10
59301SUPPL2019-07-10
48054SUPPL2017-04-18
48047SUPPL2017-04-17
17712SUPPL2015-04-14
29863SUPPL2015-04-02
44778ORIG2010-09-23
22058ORIG2010-09-23
29862ORIG2010-06-03