FDA.reportPublic FDA data

Excedrin Migraine - Select Consumer Group

Manufacturer
Select Consumer Group
Effective date
2026-07-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
weekly-update
Hydrated at
2026-07-17 21:43:27

Label at a glance#

ProductExcedrin Migraine
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections

Dosage and administration

do not use more than directed adults: take 2 caplets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 caplets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever
Pain reliever
Pain reliever aid

Use

INDICATIONS & USAGE SECTION

  • treats migraine

Warnings

WARNINGS SECTION

Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s
syndrome, a rare but serious illness.

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert:Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

Medication overuse headache warning:Headaches may worsen if this product is used for 10 or more days per month.

Caffeine warning:The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

OTC - DO NOT USE SECTION

    • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have never had migraines diagnosed by a health professional
    • you have a headache that is different from your usual migraines
    • you have the worst headache of your life
    • you have fever and stiff neck
    • you have headaches beginning after or caused by head injury, exertion, coughing or bending
    • you experienced your first headache after the age of 50
    • you have daily headaches
    • you have a migraine so severe as to require bed rest
    • you have liver disease
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have vomiting with your migraine headache

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for:
    • diabetes
    • gout
    • arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug
    • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • your migraine is not relieved or worsens after first dose
    • new or unexpected symptoms occur
    • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • adults: take 2 caplets with a glass of water
  • if symptoms persist or worsen, ask your doctor
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
  • under 18 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this box for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, carnauba wax, FD&C blue no. 1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-468-7746

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1871-61871-6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708018712GTIN-13: 0655708018712
EAN-13: 0655708018712
GTIN-12: 655708018712
UPC-A: 655708018712
GTIN storage (14 digits): 00655708018712		2501871160 - Excedrin Migraine - 1871-6.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
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a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
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bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2040-02EA - Each0067-2040ec9aa8ea-7220-432a-b26a-6391b4801c7a12023-09-05
0067-2040-03EA - Each0067-204009075a1c-87dd-41f4-8792-791dfc6bf16912025-06-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-187185237-1871-1, 85237-1871-2, 85237-1871-3, 85237-1871-4, 85237-1871-0, 85237-1871-7
0067-2040

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
CARNAUBA WAXR12CBM0EIZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LIGHT MINERAL OILN6K5787QVPIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 207T1F30V5YHIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-27full-release2026-06-01 01:28:53

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-1484e616aacf4f…
2026-08-18 06:07:402026-07N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14caaa826d4ba7…
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…

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
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINESelect Consumer Group3caa4adf-abe3-67c3-e063-6294a90a87a42026-07-03WarningsExact identifier
ndc (package): 85237-1871-7
ndc (package): 85237-1871-2
ndc (package): 85237-1871-4
ndc (package): 85237-1871-0
ndc (package): 85237-1871-1
ndc (package): 85237-1871-3
ndc (product): 85237-1871
ndc11 (package): 85237187103
ndc11 (package): 85237187102
ndc11 (package): 85237187104
ndc11 (package): 85237187100
ndc11 (package): 85237187101
ndc11 (package): 85237187107
spl id: 55bd0e62-bda4-cfcd-e063-6394a90afbb1
spl set id: 3caa4adf-abe3-67c3-e063-6294a90a87a4
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEHaleon US Holdings LLC910d7254-d0f4-4c5c-a26e-7f8acecbe02d2025-03-11WarningsExact identifier
ndc (product): 0067-2040

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.