FDA.reportPublic FDA data

Application 018989

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVILIBUPROFENTABLET;ORAL200MGNoNo

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
N018989-001ADVILIBUPROFEN200MGTABLET / ORALRLD, RS1984-05-18

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 UTC2022-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVILIBUPROFENSelect Consumer Group3ca752d8-957c-21b4-e063-6294a90a52852026-07-03WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
AdvilIBUPROFENNavajo Manufacturing Company Inc.4a64522f-b7d8-47f7-bf07-c9e8f10864252026-04-08WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
ndc (product): 67751-146
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
ndc (product): 0573-0151
ndc (product): 0573-0160
ndc (product): 0573-1711
ndc (product): 0573-0154
ndc (product): 0573-0161
ndc (product): 0573-0165
ndc (product): 0573-0150
ndc (product): 0573-0166
AdvilIBUPROFENLil' Drug Store Products, Inc.772360bd-8631-4d24-b4db-5a7e6e1d9a132025-01-27WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
ndc (product): 66715-9700
AdvilIBUPROFEN TABLETS, COATEDLil' Drug Store Products, Inc.dd302e18-39e9-7e1a-e053-2a95a90a5f7c2024-07-17WarningsExact identifier
application applno (NDA): 018989
application number: NDA018989
ndc (product): 66715-5803

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 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0150ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0150ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0150ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0150ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0150ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0150ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0151ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0151ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0151ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0151ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0151ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0151ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0154ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0154ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0154ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0154ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0154ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0154ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0160ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0160ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0160ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0160ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0160ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0160ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0161ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0161ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0161ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0161ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0161ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0161ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0165ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0165ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0165ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0165ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0165ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0165ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0166ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0166ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0166ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0166ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0166ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0166ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1711ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1711ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1711ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1711ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1711ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1711ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-1005ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-1005ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-1005ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6500ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6749ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6749ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6749ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-7012ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-7012ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-7012ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
52904-786ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
52904-790ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
52904-791ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
52904-794ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
66715-5803AdvilIbuprofen Tablets, coatedLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
67751-146AdvilIBUPROFENNavajo Manufacturing Company Inc.NDACurrent
67751-146AdvilIBUPROFENNavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81685SUPPL 2025-03-24
80803SUPPL 2025-01-02
69581SUPPL2021-12-16
69580SUPPL2021-12-16
56483SUPPL2018-11-23
56489SUPPL2018-11-16
55926SUPPL2018-10-15
55882SUPPL2018-10-11
49622SUPPL2017-08-30
49575SUPPL2017-08-29
11407SUPPL2015-12-22
1186SUPPL2015-12-18
33680SUPPL2012-03-27
1184SUPPL2011-04-28
1185SUPPL2010-09-07
16163SUPPL2009-05-26
1183SUPPL2008-06-13
16162SUPPL2007-05-07
11406SUPPL2007-05-07
16161SUPPL2006-04-20
1182SUPPL2006-04-07
1181SUPPL2004-07-21
16159SUPPL2004-05-26
11404SUPPL2004-05-26
16160SUPPL2003-09-30
11405SUPPL2003-09-30
11403SUPPL2003-04-23