EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine

Product NDC
29485-8028
11-digit product format
294858028
Labeler code
29485
Product ID
29485-8028_e65e5d44-5171-53b4-e053-2a95a90a0b7d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, and Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mechanical Servants LLC
Application
NDA020802
Marketing category
NDA
Marketing start
2010-02-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct29485-8028DDiscontinued by firm2026-08-07
excluded packagepackage29485-802829485-8028-6DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-143f01610625f2…
2019-09-15 20:21 UTC2019-09N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020802-001EXCEDRIN (MIGRAINE)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14f41ea6bd6efb…
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…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-8028EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]5Legacy NDC20230721_20406b7d-c989-40a5-b066-f3336c27a5fa.zip

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 · 11 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
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
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN, CAFFEINEJC World Bell Wholesale Co., Inc29b764c7-3d07-5191-e063-6294a90a9c302024-12-23WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
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
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
Excedrin Migraine GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLCcc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff82024-01-28WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEAllegiant Health6197eff5-0351-42ef-bb3f-cbc26e6d0d142018-12-28WarningsExact identifier
application applno (NDA): 020802
application number: NDA020802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29485-8028-6294858028063 POUCH in 1 CARTON (29485-8028-6) > 2 TABLET, FILM COATED in 1 POUCH3 pouch2010-02-150000-00-00NoNoCurrent