Excedrin

Manufacturer: Haleon US Holdings LLC
Effective date: 2024-01-28
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:07:59

Label at a glance#

ProductExcedrin Migraine Geltabs

Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE

Label structure10 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-452-0051

Websitewww.excedrin.com

www.excedrin.com

Label contents#

Full prescribing information#

Active ingredients (in each GelTab)

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

Other information

SPL UNCLASSIFIED 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, D&C yellow #10 aluminum lake, disodium EDTA, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, ferric oxide, gelatin, glycerin, hydroxypropylcellulose, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-452-0051

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0067-2035-20

See new warnings information

Excedrin®

Migraine

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain reliever / Pain Reliever Aid

20GELTABS*

*GELATIN COATED 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 HealthcareWarren, NJ 07059

Visit us at www.excedrin.com

62000000012939

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	PSN	8
209468	EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet	PSN	8
209468	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]	SBD	8
308297	acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet	SCD	8
308297	APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet	SY	8
209468	APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]	SY	8
209468	Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	8
209468	Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	8
209468	Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASPIRIN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20191108
CAFFEINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0067-2035-16	ExcedrinMigraine Geltabs	2 in 1 CARTON	TABLET, COATED	2	8
0067-2035-16	ExcedrinMigraine Geltabs	160 in 1 BOTTLE	TABLET, COATED	160	8
0067-2035-20	ExcedrinMigraine Geltabs	20 in 1 BOTTLE	TABLET, COATED	20	8
0067-2035-20	ExcedrinMigraine Geltabs	1 in 1 CARTON	TABLET, COATED	1	8
0067-2035-24	ExcedrinMigraine Geltabs	24 in 1 BOTTLE	TABLET, COATED	24	8
0067-2035-24	ExcedrinMigraine Geltabs	1 in 1 CARTON	TABLET, COATED	1	8
0067-2035-50	ExcedrinMigraine Geltabs	1 in 1 CARTON	TABLET, COATED	1	8
0067-2035-50	ExcedrinMigraine Geltabs	50 in 1 BOTTLE	TABLET, COATED	50	8
0067-2035-80	ExcedrinMigraine Geltabs	1 in 1 CARTON	TABLET, COATED	1	8
0067-2035-80	ExcedrinMigraine Geltabs	80 in 1 BOTTLE	TABLET, COATED	80	8
0067-2035-91	ExcedrinMigraine Geltabs	100 in 1 BOTTLE	TABLET, COATED	100	8
0067-2035-91	ExcedrinMigraine Geltabs	2 in 1 CARTON	TABLET, COATED	2	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-2035	EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [HALEON US HOLDINGS LLC]	8	Current NDC, Legacy NDC, 12 package rows	20240129_cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-2035-16	EA - Each	0067-2035	f7b73f8f-c033-4e1b-92b5-5cb08865f79b	1	2013-02-13
0067-2035-20	EA - Each	0067-2035	493d95ca-ebab-48f8-b926-0ec4cfee11d7	1	2015-11-12
0067-2035-24	EA - Each	0067-2035	b68a9f31-8b32-441d-836a-6825f9c9627c	1	2013-02-13
0067-2035-50	EA - Each	0067-2035	ce883033-a5d0-4dc6-b0ca-9dd7c8fce3b3	1	2013-02-13
0067-2035-91	EA - Each	0067-2035	1e5b9da2-b570-472b-89ae-f8fce7093951	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	2
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	2
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	2
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	2
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
PEPSIN	INACTIVE INGREDIENT	GID333S43J	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	2
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

Excedrin Migraine Geltabs
Acetaminophen, Asprin, Caffeine
BENZOIC ACID
D&C YELLOW NO. 10
EDETATE DISODIUM ANHYDROUS
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
GELATIN, UNSPECIFIED
GLYCERIN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
LIGHT MINERAL OIL
MALTITOL
MEDIUM-CHAIN TRIGLYCERIDES
MICROCRYSTALLINE CELLULOSE
PEPSIN
POLYSORBATE 20
POVIDONE, UNSPECIFIED
PROPYL GALLATE
PROPYLENE GLYCOL
DIMETHICONE
SILICON DIOXIDE
SORBITAN MONOLAURATE
STEARIC ACID
TITANIUM DIOXIDE
ACETAMINOPHEN
ASPIRIN
CAFFEINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0067-2035	0067-2035-20, 0067-2035-24, 0067-2035-50, 0067-2035-80, 0067-2035-91, 0067-2035-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOIC ACID	8SKN0B0MIM	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
EDETATE DISODIUM ANHYDROUS	8NLQ36F6MM	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
MALTITOL	D65DG142WK	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
PEPSIN	GID333S43J	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
PROPYL GALLATE	8D4SNN7V92	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITAN MONOLAURATE	6W9PS8B71J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
ASPIRIN	R16CO5Y76E	ACTIB
CAFFEINE	3G6A5W338E	ACTIB

Source Document#

Source XML · Source PDF

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 6 · 343 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	TABLET, FILM COATED / ORAL		800 mg	Exact identifier — unii+route 42 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	FILM, SOLUBLE / ORAL		44 mg	Exact identifier — unii+route 35 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SUSPENSION / ORAL	39600 mg/120ml		Exact identifier — unii+route 35 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii+route 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii+route 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii+route 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 42 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	FILM, SOLUBLE / ORAL		44 mg	Exact identifier — unii+route 35 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	TABLET, FILM COATED / ORAL	0.04 mg		Exact identifier — unii+route 42 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii+route 49 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	EMULSION / ORAL	NA		Exact identifier — unii+route 42 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii+route 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 42 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, COATED / ORAL	4.8 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii+route 49 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii+route 49 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	FILM, SOLUBLE / ORAL		44 mg	Exact identifier — unii+route 35 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SUSPENSION / ORAL	39600 mg/120ml		Exact identifier — unii+route 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route 35 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii+route 42 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii+route 49 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route 35 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	FILM, SOLUBLE / ORAL		44 mg	Exact identifier — unii+route 35 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 49 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii+route 49 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	EMULSION / ORAL	NA		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii+route 49 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 49 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route 35 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SUSPENSION / ORAL	39600 mg/120ml		Exact identifier — unii+route 35 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	TABLET, FILM COATED / ORAL		800 mg	Exact identifier — unii+route 42 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	CAPSULE / ORAL		155 mg	Exact identifier — unii+route 35 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	CAPSULE / ORAL		155 mg	Exact identifier — unii+route 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii+route 42 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	TABLET / ORAL		800 mg	Exact identifier — unii+route 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii+route 42 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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020802-001	EXCEDRIN (MIGRAINE RELIEF)	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL		RLD, RS	1998-01-14

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020802-001	EXCEDRIN (MIGRAINE RELIEF)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Migraine Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8	2024-01-28	Warnings	Exact identifier ndc (package): 0067-2035-20 ndc (package): 0067-2035-80 ndc (package): 0067-2035-50 ndc (package): 0067-2035-91 ndc (package): 0067-2035-16 ndc (package): 0067-2035-24 ndc (product): 0067-2035 ndc11 (package): 00067203520 ndc11 (package): 00067203580 ndc11 (package): 00067203591 ndc11 (package): 00067203516 ndc11 (package): 00067203524 ndc11 (package): 00067203550 spl id: 1006aaaa-a4ed-a80e-e063-6294a90a6bc6 spl set id: cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8

Reported adverse events (FAERS/openFDA)#

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