FDA.reportPublic FDA data

Application 020812

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEDIATRIC ADVILIBUPROFENSUSPENSION/DROPS;ORAL100MG/2.5MLYesNo
002INFANT'S ADVILIBUPROFENSUSPENSION/DROPS;ORAL50MG/1.25MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020812-001PEDIATRIC ADVILIBUPROFEN100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30
N020812-002INFANT'S ADVILIBUPROFEN50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12

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 1 of 3 · 83 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020812-001PEDIATRIC ADVIL100MG/2.5MLSUSPENSION/DROPS / ORALRLD1998-01-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020812-002INFANT'S ADVIL50MG/1.25MLSUSPENSION/DROPS / ORALRLD, RS2000-01-12bb7c543d1eb4…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS ADVILIBUPROFENHaleon US Holdings LLCdb5ed801-7a7e-3c83-0172-77f914daaa5a2024-11-26WarningsExact identifier
application applno (NDA): 020812
application number: NDA020812
ndc (product): 0573-0191

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0191INFANTS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0191INFANTS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0191INFANTS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0191INFANTS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48950SUPPL2017-07-11
48941SUPPL2017-07-11
47748SUPPL2017-03-29
47744SUPPL2017-03-29
35394SUPPL2013-08-05
25884SUPPL2013-07-26
41717SUPPL2013-05-10
20972SUPPL2013-04-18
3403SUPPL2011-04-28
25883SUPPL2009-05-27
25882SUPPL2008-06-16
35393SUPPL2006-07-18
3402SUPPL2006-04-07
20971ORIG2005-06-23
3401SUPPL2004-09-15