Application 020802

Type: NDA
Sponsor: GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXCEDRIN (MIGRAINE)	ACETAMINOPHEN; ASPIRIN; CAFFEINE	TABLET;ORAL	250MG;250MG;65MG	Yes	Yes

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-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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020802-001	EXCEDRIN (MIGRAINE)	250MG;250MG;65MG	TABLET / ORAL	RLD, RS	1998-01-14	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Select Consumer Group	3caa4adf-abe3-67c3-e063-6294a90a87a4	2026-07-03	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Navajo Manufacturing Company Inc.	4efbd21b-92fe-96a7-e063-6294a90ac4ad	2026-04-08	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Haleon US Holdings LLC	7ed841fb-a61c-4868-b4e5-4f2311a5e79c	2025-06-25	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802 ndc (product): 0067-2039
Excedrin Migraine Relief	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Haleon US Holdings LLC	dd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d8	2025-03-11	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Haleon US Holdings LLC	910d7254-d0f4-4c5c-a26e-7f8acecbe02d	2025-03-11	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802 ndc (product): 0067-2040
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN, CAFFEINE	JC World Bell Wholesale Co., Inc	29b764c7-3d07-5191-e063-6294a90a9c30	2024-12-23	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
Excedrin Migraine, TRAVEL BASIX	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	40aeb2c5-a37b-446d-9918-8378a75ff327	2024-12-13	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802 ndc (product): 66715-9749
Excedrin Migraine	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	A-S Medication Solutions	d012ed1d-b256-48ec-b988-f226c2c5ae9e	2024-05-29	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Haleon US Holdings LLC	920c8898-e222-4b91-afc5-04d25317ade7	2024-03-14	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802 ndc (product): 0067-8201
Excedrin Migraine Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8	2024-01-28	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802 ndc (product): 0067-2035
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Allegiant Health	6197eff5-0351-42ef-bb3f-cbc26e6d0d14	2018-12-28	Warnings	Exact identifier application applno (NDA): 020802 application number: NDA020802 ndc (product): 69168-285

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-2035	Excedrin	Acetaminophen, Asprin, Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2035	Excedrin	Acetaminophen, Asprin, Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2035	Excedrin	Acetaminophen, Asprin, Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2039	EXCEDRIN	Acetaminophen, Aspirin (NSAID) and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2039	EXCEDRIN	Acetaminophen, Aspirin (NSAID) and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2039	EXCEDRIN	Acetaminophen, Aspirin (NSAID) and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2040	Excedrin	Acetaminophen, Aspirin, and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2040	Excedrin	Acetaminophen, Aspirin, and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2040	Excedrin	Acetaminophen, Aspirin, and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2040	Excedrin	Acetaminophen, Aspirin, and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-2040	Excedrin	Acetaminophen, Aspirin, and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-8201	EXCEDRIN	Acetaminophen, Aspirin (NSAID) and Caffeine	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
29485-8028	EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine	Acetaminophen, Aspirin, and Caffeine	Mechanical Servants LLC	NDA	Current
29485-8028	EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine	Acetaminophen, Aspirin, and Caffeine	Mechanical Servants LLC	NDA	Current
29485-8028	EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine	Acetaminophen, Aspirin, and Caffeine	Mechanical Servants LLC	NDA	Current
29485-8028	EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine	Acetaminophen, Aspirin, and Caffeine	Mechanical Servants LLC	NDA	Current
52904-871	Excedrin Migraine	acetaminophen, aspirin, and caffeine	Select Corporation	NDA	Current
53808-0835	EXCEDRIN	Acetaminophen, Aspirin (NSAID) and Caffeine	State of Florida DOH Central Pharmacy	NDA	Current
66715-9749	Excedrin Migraine	acetaminophen, aspirin, and caffeine	Lil' Drug Store Products, Inc.	NDA	Current
66715-9749	Excedrin Migraine	acetaminophen, aspirin, and caffeine	Lil' Drug Store Products, Inc.	NDA	Current
66715-9749	Excedrin Migraine	acetaminophen, aspirin, and caffeine	Lil' Drug Store Products, Inc.	NDA	Current
69168-285	Headache Relief	Acetaminophen, Aspirin and Caffeine	Allegiant Health	NDA	Current
69168-285	Headache Relief	Acetaminophen, Aspirin and Caffeine	Allegiant Health	NDA	Current
69168-285	Headache Relief	Acetaminophen, Aspirin and Caffeine	Allegiant Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74272	SUPPL	2023-05-16
74267	SUPPL	2023-05-16
74022	SUPPL	2023-04-19
74021	SUPPL	2023-04-19
69539	SUPPL	2021-12-13
69523	SUPPL	2021-12-09
69285	SUPPL	2021-11-09
69227	SUPPL	2021-11-04
61995	SUPPL	2020-02-28
61994	SUPPL	2020-02-28
50959	SUPPL	2019-04-19
58342	SUPPL	2019-04-16
58341	SUPPL	2019-04-16
50960	SUPPL	2018-01-09
50205	SUPPL	2017-10-27
50080	SUPPL	2017-10-18
13465	SUPPL	2014-07-30
3396	SUPPL	2014-07-17
13464	SUPPL	2014-04-22
25874	SUPPL	2014-04-17
25873	SUPPL	2010-02-17
25872	SUPPL	2007-02-12
41711	ORIG	2005-07-13
25871	SUPPL	2004-08-31
13463	SUPPL	2003-06-08
3395	SUPPL	2003-06-08
41712	SUPPL	1999-10-07
35388	SUPPL	1999-10-07
3394	SUPPL	1999-10-07