FDA.reportPublic FDA data

Application 020944

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S ADVILIBUPROFENTABLET, CHEWABLE;ORAL50MGNoNo
002JUNIOR STRENGTH ADVILIBUPROFENTABLET, CHEWABLE;ORAL100MGNoNo

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
N020944-001CHILDREN'S ADVILIBUPROFEN50MGTABLET, CHEWABLE / ORAL1998-12-18
N020944-002JUNIOR STRENGTH ADVILIBUPROFEN100MGTABLET, CHEWABLE / ORAL1998-12-18

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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020944-001CHILDREN'S ADVIL50MGTABLET, CHEWABLE / ORAL1998-12-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020944-002JUNIOR STRENGTH ADVIL100MGTABLET, CHEWABLE / ORAL1998-12-18bb7c543d1eb4…

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
JUNIOR STRENGTH ADVILIBUPROFENHaleon US Holdings LLC07d4c400-b182-92f7-7574-9e0e94c39cce2025-06-27WarningsExact identifier
application applno (NDA): 020944
application number: NDA020944
ndc (product): 0573-0179
JUNIOR STRENGTH ADVILIBUPROFENProficient Rx LP91fc4794-1880-460f-86dd-49d8c1e872bc2020-03-01WarningsExact identifier
application applno (NDA): 020944
application number: NDA020944
ndc (product): 71205-425

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0179JUNIOR STRENGTH ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0179JUNIOR STRENGTH ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
71205-425JUNIOR STRENGTH ADVILibuprofenProficient Rx LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85821SUPPL 2026-05-04
47766SUPPL2017-03-29
47743SUPPL2017-03-28
41827SUPPL2013-04-18
21296SUPPL2013-04-18
3821SUPPL2009-05-27
3820SUPPL2008-06-13
26266SUPPL2006-04-07
26265SUPPL2004-12-30
3819SUPPL2004-12-30
21295ORIG2004-05-26
35691ORIG1998-12-18
3818ORIG1998-12-18