EXCEDRIN

Manufacturer
Haleon US Holdings LLC
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:03:56

Label at a glance#

ProductEXCEDRIN MIGRAINE
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections

Indications and uses

• treats migraine

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

Storage and handling

• 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.

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

Purpose

OTC - PURPOSE SECTION

Pain reliever
Pain reliever
Pain reliever aid

Uses

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 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 during the last 3 months of 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

STORAGE AND HANDLING SECTION

  • 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 #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-468-7746

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-2039-24

See new warnings information

EXCEDRIN®

MIGRAINE

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

24

CAPLETS*

*CAPSULE-SHAPED TABLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2017 GSK or its licensor.

Visit us at www.excedrin.com

62000000012933

62000000012933_Excedrin Migraine Caplets_24 ct.JPG
62000000012933_Excedrin Migraine Caplets_24 ct.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN14
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSN14
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBD14
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD14
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY14
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SY14
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY14
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY14
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSY14

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-2039-022023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-072023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-082023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-092023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-242023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-302023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-332023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-502023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-772023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-832023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-842023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-862023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-912023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-922023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-942023-05-03C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-022022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-072022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-082022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-092022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-242022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-302022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-332022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-502022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-772022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-832022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-842022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-862022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-912022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-922022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts
0067-2039-942022-07-29C16284748780-1e4f33bdf-a6ba-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2039-02EXCEDRINMIGRAINE2 in 1 POUCHTABLET, FILM COATED214
0067-2039-07EXCEDRINMIGRAINE250 in 1 BOTTLETABLET, FILM COATED25014
0067-2039-08EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-08EXCEDRINMIGRAINE8 in 1 BOTTLETABLET, FILM COATED814
0067-2039-09EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-09EXCEDRINMIGRAINE10 in 1 BOTTLETABLET, FILM COATED1014
0067-2039-24EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-24EXCEDRINMIGRAINE24 in 1 BOTTLETABLET, FILM COATED2414
0067-2039-30EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-30EXCEDRINMIGRAINE30 in 1 BOTTLETABLET, FILM COATED3014
0067-2039-33EXCEDRINMIGRAINE300 in 1 BOTTLETABLET, FILM COATED30014
0067-2039-33EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-50EXCEDRINMIGRAINE50 in 1 BOTTLETABLET, FILM COATED5014
0067-2039-50EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-77EXCEDRINMIGRAINE250 in 1 BOTTLETABLET, FILM COATED25014
0067-2039-77EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-83EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-83EXCEDRINMIGRAINE125 in 1 BOTTLETABLET, FILM COATED12514
0067-2039-84EXCEDRINMIGRAINE125 in 1 BOTTLETABLET, FILM COATED12514
0067-2039-86EXCEDRINMIGRAINE125 in 1 BOTTLETABLET, FILM COATED12514
0067-2039-86EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-91EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-91EXCEDRINMIGRAINE100 in 1 BOTTLETABLET, FILM COATED10014
0067-2039-92EXCEDRINMIGRAINE1 in 1 CARTONTABLET, FILM COATED114
0067-2039-92EXCEDRINMIGRAINE200 in 1 BOTTLETABLET, FILM COATED20014
0067-2039-94EXCEDRINMIGRAINE100 in 1 BOTTLETABLET, FILM COATED10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2039-08EA - Each0067-203916ce8a4b-bd70-4a64-ad07-8ff387eb663812012-07-24
0067-2039-24EA - Each0067-2039bbb39c99-180a-437a-85d0-e53a1eb91ead12012-07-24
0067-2039-33EA - Each0067-20397b55aa5b-c0f7-4ea7-b9a8-55228dc5e47412014-09-03
0067-2039-50EA - Each0067-203922e8dd78-54d4-44ec-a754-b64ce6da0b2712012-07-24
0067-2039-77EA - Each0067-2039e7beb6f2-112b-44d1-bc0c-8cc04775044112012-07-24
0067-2039-83EA - Each0067-2039aeb6329a-c0f6-4dbe-89e3-ff583f2b8adc12024-04-05
0067-2039-86EA - Each0067-2039dfab005f-c6a2-4e68-af6a-5340d2fe2e8312015-10-02
0067-2039-91EA - Each0067-2039baa7e6be-1a22-4946-bd6d-398153fc039712012-07-24
0067-2039-92EA - Each0067-2039517a3c30-8e99-41dd-8798-e5871b87f0ac12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D6
ASPIRINACTIVE INGREDIENTR16CO5Y76E6
CAFFEINEACTIVE INGREDIENT3G6A5W338E6
ACETAMINOPHENACTIVE MOIETY362O9ITL9D6
ASPIRINACTIVE MOIETYR16CO5Y76E6
CAFFEINEACTIVE MOIETY3G6A5W338E6
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH6
POVIDONESINACTIVE INGREDIENTFZ989GH94E6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71J6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP6

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 208 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITAN MONOLAURATESORBITAN MONOLAURATE6W9PS8B71JTABLET, FILM COATED / ORAL800 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED / ORAL131.67 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITAN MONOLAURATESORBITAN MONOLAURATE6W9PS8B71JTABLET, FILM COATED / ORAL800 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020802-001EXCEDRIN (MIGRAINE RELIEF)250MG;250MG;65MGTABLET / ORALRLD, RS1998-01-14c2088c7a36db…
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…

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
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEHaleon US Holdings LLC7ed841fb-a61c-4868-b4e5-4f2311a5e79c2025-06-25WarningsExact identifier
ndc (package): 0067-2039-84
ndc (package): 0067-2039-30
ndc (package): 0067-2039-08
ndc (package): 0067-2039-07
ndc (package): 0067-2039-50
ndc (package): 0067-2039-86
ndc (package): 0067-2039-02
ndc (package): 0067-2039-77
ndc (package): 0067-2039-94
ndc (package): 0067-2039-92
ndc (package): 0067-2039-91
ndc (package): 0067-2039-33
ndc (package): 0067-2039-09
ndc (package): 0067-2039-83
ndc (package): 0067-2039-24
ndc (product): 0067-2039
ndc11 (package): 00067203907
ndc11 (package): 00067203984
ndc11 (package): 00067203992
ndc11 (package): 00067203924
ndc11 (package): 00067203994
ndc11 (package): 00067203909
ndc11 (package): 00067203977
ndc11 (package): 00067203902
ndc11 (package): 00067203908
ndc11 (package): 00067203950
ndc11 (package): 00067203930
ndc11 (package): 00067203933
ndc11 (package): 00067203983
ndc11 (package): 00067203991
ndc11 (package): 00067203986
spl id: 7386648a-3c0a-4586-9b61-fd824edfdfc1
spl set id: 7ed841fb-a61c-4868-b4e5-4f2311a5e79c

Reported adverse events (FAERS/openFDA)#

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