FDA.reportPublic FDA data

Application 020802

Type
NDA
Sponsor
GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXCEDRIN (MIGRAINE)ACETAMINOPHEN; ASPIRIN; CAFFEINETABLET;ORAL250MG;250MG;65MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020802-001EXCEDRIN (MIGRAINE RELIEF)ACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINESelect Consumer Group3caa4adf-abe3-67c3-e063-6294a90a87a42026-07-03WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEHaleon US Holdings LLC7ed841fb-a61c-4868-b4e5-4f2311a5e79c2025-06-25WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
ndc (product): 0067-2039
Excedrin Migraine ReliefACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLCdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d82025-03-11WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEHaleon US Holdings LLC910d7254-d0f4-4c5c-a26e-7f8acecbe02d2025-03-11WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
ndc (product): 0067-2040
Excedrin Migraine, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.40aeb2c5-a37b-446d-9918-8378a75ff3272024-12-13WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
ndc (product): 66715-9749
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEA-S Medication Solutionsd012ed1d-b256-48ec-b988-f226c2c5ae9e2024-05-29WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEHaleon US Holdings LLC920c8898-e222-4b91-afc5-04d25317ade72024-03-14WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
ndc (product): 0067-8201
Excedrin Migraine GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLCcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff82024-01-28WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
ndc (product): 0067-2035

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-2035ExcedrinAcetaminophen, Asprin, CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2035ExcedrinAcetaminophen, Asprin, CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2035ExcedrinAcetaminophen, Asprin, CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2039EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2039EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2039EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-2040ExcedrinAcetaminophen, Aspirin, and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-8201EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
29485-8028EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeineAcetaminophen, Aspirin, and CaffeineMechanical Servants LLCNDACurrent
52904-871Excedrin Migraineacetaminophen, aspirin, and caffeineSelect CorporationNDACurrent
53808-0835EXCEDRINAcetaminophen, Aspirin (NSAID) and CaffeineState of Florida DOH Central PharmacyNDACurrent
66715-9749Excedrin Migraineacetaminophen, aspirin, and caffeineLil' Drug Store Products, Inc.NDACurrent
66715-9749Excedrin Migraineacetaminophen, aspirin, and caffeineLil' Drug Store Products, Inc.NDACurrent
66715-9749Excedrin Migraineacetaminophen, aspirin, and caffeineLil' Drug Store Products, Inc.NDACurrent
69168-285Headache ReliefAcetaminophen, Aspirin and CaffeineAllegiant HealthNDACurrent
69168-285Headache ReliefAcetaminophen, Aspirin and CaffeineAllegiant HealthNDACurrent
69168-285Headache ReliefAcetaminophen, Aspirin and CaffeineAllegiant HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74272SUPPL 2023-05-16
74267SUPPL 2023-05-16
74022SUPPL 2023-04-19
74021SUPPL 2023-04-19
69539SUPPL2021-12-13
69523SUPPL2021-12-09
69285SUPPL2021-11-09
69227SUPPL2021-11-04
61995SUPPL2020-02-28
61994SUPPL2020-02-28
50959SUPPL2019-04-19
58342SUPPL2019-04-16
58341SUPPL2019-04-16
50960SUPPL2018-01-09
50205SUPPL2017-10-27
50080SUPPL2017-10-18
13465SUPPL2014-07-30
3396SUPPL2014-07-17
13464SUPPL2014-04-22
25874SUPPL2014-04-17
25873SUPPL2010-02-17
25872SUPPL2007-02-12
41711ORIG2005-07-13
25871SUPPL2004-08-31
13463SUPPL2003-06-08
3395SUPPL2003-06-08
41712SUPPL1999-10-07
35388SUPPL1999-10-07
3394SUPPL1999-10-07