Application 075794

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	TABLET;ORAL	250MG;250MG;65MG	No	No

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
A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL			2001-11-26

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DG Health migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, LLC	d0e82cac-dfbb-49cb-99c8-560b02fb1a8c	2023-04-05	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794 ndc (product): 55910-374
basic care migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Amazon.com Services LLC	edcc7b4b-1317-4060-b947-8c16effc5742	2023-02-27	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
leader migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Cardinal Health 110, LLC. dba Leader	edf22989-fa56-4d83-9b88-912e0d14ac86	2022-08-08	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
basic care migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Amazon.com Services LLC	a19798b3-1b2e-4e4f-b595-2a156bd52ee5	2022-07-28	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
topcare migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Topco Associates LLC	9163ecfe-6493-46eb-a08d-b4134d84b0ab	2022-06-28	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794 ndc (product): 36800-934
dg health migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp Inc	673d42d8-b484-4232-bc91-19d83db63550	2022-06-07	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794 ndc (product): 55910-448

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0374	good sense migraine formula	Acetaminophen, Aspirin, Caffeine	L. Perrigo Company	ANDA	Current
0113-0374	good sense migraine formula	Acetaminophen, Aspirin, Caffeine	L. Perrigo Company	ANDA	Current
0113-1619	good sense migraine formula	acetaminophen, aspirin, caffeine	L. Perrigo Company	ANDA	Current
0113-7374	basic care migraine relief	Acetaminophen, Aspirin, Caffeine	L. Perrigo Company	ANDA	Current
0363-0374	migraine relief	Acetaminophen, Aspirin, Caffeine	Walgreen Company	ANDA	Current
0363-0374	migraine relief	Acetaminophen, Aspirin, Caffeine	Walgreen Company	ANDA	Current
0363-0374	migraine relief	Acetaminophen, Aspirin, Caffeine	Walgreen Company	ANDA	Current
0363-1235	migraine relief	acetaminophen, aspirin, caffeine	Walgreen Company	ANDA	Current
10202-374	7 Select Migraine Formula	Acetaminophen, Aspirin, Caffeine	7-Eleven	ANDA	Current
10202-374	7 Select Migraine Formula	Acetaminophen, Aspirin, Caffeine	7-Eleven	ANDA	Current
11673-374	Up and Up Migraine Relief	Acetaminophen, Aspirin, Caffeine	Target Corporation	ANDA	Current
11822-0374	migraine relief	Acetaminophen, Aspirin, Caffeine	Rite Aid Corporation	ANDA	Current
11822-0374	migraine relief	Acetaminophen, Aspirin, Caffeine	Rite Aid Corporation	ANDA	Current
11822-0374	migraine relief	Acetaminophen, Aspirin, Caffeine	Rite Aid Corporation	ANDA	Current
11822-1121	migraine relief	Acetaminophen, Aspirin, Caffeine	Rite Aid Corporation	ANDA	Current
21130-569	Signature Care Migraine Relief	Acetaminophen, Aspirin, Caffeine	Safeway	ANDA	Current
21130-569	Signature Care Migraine Relief	Acetaminophen, Aspirin, Caffeine	Safeway	ANDA	Current
24385-365	good neighbor pharmacy migraine relief	Acetaminophen, Aspirin, Caffeine	Amerisource Bergen	ANDA	Current
24385-365	good neighbor pharmacy migraine relief	Acetaminophen, Aspirin, Caffeine	Amerisource Bergen	ANDA	Current
30142-374	migraine formula	Acetaminophen, Aspirin, Caffeine	Kroger Company	ANDA	Current
30142-374	migraine formula	Acetaminophen, Aspirin, Caffeine	Kroger Company	ANDA	Current
30142-896	migraine relief	acetaminophen, aspirin, caffeine	Kroger Company	ANDA	Current
30142-896	migraine relief	acetaminophen, aspirin, caffeine	Kroger Company	ANDA	Current
36800-374	Topcare Migraine Formula	Acetaminophen, Aspirin, Caffeine	Topco Associates LLC	ANDA	Current
36800-374	Topcare Migraine Formula	Acetaminophen, Aspirin, Caffeine	Topco Associates LLC	ANDA	Current
36800-533	Topcare Migraine Relief	Acetaminophen, Aspirin, Caffeine	Topco Associates LLC	ANDA	Current
36800-533	Topcare Migraine Relief	Acetaminophen, Aspirin, Caffeine	Topco Associates LLC	ANDA	Current
36800-533	Topcare Migraine Relief	Acetaminophen, Aspirin, Caffeine	Topco Associates LLC	ANDA	Current
36800-934	topcare migraine relief	Acetaminophen, Aspirin, Caffeine	Topco Associates LLC	ANDA	Current
37012-374	Migraine Relief	Acetaminophen, Aspirin, Caffeine	Shopko Stores Operating Co., LLC	ANDA	Current
37012-374	Migraine Relief	Acetaminophen, Aspirin, Caffeine	Shopko Stores Operating Co., LLC	ANDA	Current
37808-374	migraine formula	Acetaminophen, Aspirin, Caffeine	H E B	ANDA	Current
37808-374	migraine formula	Acetaminophen, Aspirin, Caffeine	H E B	ANDA	Current
41163-374	Equaline migraine formula	Acetaminophen, Aspirin, Caffeine	Supervalu Inc	ANDA	Current
41163-374	Equaline migraine formula	Acetaminophen, Aspirin, Caffeine	Supervalu Inc	ANDA	Current
41190-374	ShopRite Migraine Formula	Acetaminophen, Aspirin, Caffeine	Wakefern Food Corporation	ANDA	Current
41190-374	ShopRite Migraine Formula	Acetaminophen, Aspirin, Caffeine	Wakefern Food Corporation	ANDA	Current
41250-374	migraine formula	Acetaminophen, Aspirin, Caffeine	Meijer Distribution Inc	ANDA	Current
41250-374	migraine formula	Acetaminophen, Aspirin, Caffeine	Meijer Distribution Inc	ANDA	Current
41520-374	Care One migraine relief	Acetaminophen, Aspirin, Caffeine	American Sales Company	ANDA	Current
41520-374	Care One migraine relief	Acetaminophen, Aspirin, Caffeine	American Sales Company	ANDA	Current
42961-202	Xpect Pain Away	Pain Reliever	Cintas Corporation	ANDA	Current
49348-506	Sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
49348-506	Sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
49348-506	Sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	McKesson	ANDA	Current
49348-506	Sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
49348-506	Sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
49738-374	Smart Sense migraine relief	Acetaminophen, Aspirin, Caffeine	Kmart Corporation	ANDA	Current
49738-374	Smart Sense migraine relief	Acetaminophen, Aspirin, Caffeine	Kmart Corporation	ANDA	Current
49738-444	Smart Sense Migraine Formula	Acetaminophen, Aspirin, Caffeine	Kmart Corporation	ANDA	Current
49738-444	Smart Sense Migraine Formula	Acetaminophen, Aspirin, Caffeine	Kmart Corporation	ANDA	Current
50594-374	sound body migraine relief	Acetaminophen, Aspirin, Caffeine	Big Lots Stores, Inc.	ANDA	Current
55316-374	Healthy Accents migraine formula	Acetaminophen, Aspirin, Caffeine	DZA Brands LLC	ANDA	Current
55316-374	Healthy Accents migraine formula	Acetaminophen, Aspirin, Caffeine	DZA Brands LLC	ANDA	Current
55319-374	Family Wellness Migraine Relief	Acetaminophen, Aspirin, Caffeine	Family Dollar Services Inc	ANDA	Current
55319-553	family wellness migraine	Acetaminophen, Aspirin, Caffeine	Family Dollar Services Inc	ANDA	Current
55319-553	family wellness migraine	Acetaminophen, Aspirin, Caffeine	Family Dollar Services Inc	ANDA	Current
55910-374	DG Health migraine relief	Acetaminophen, Aspirin, Caffeine	Dolgencorp, LLC	ANDA	Current
55910-374	DG Health migraine relief	Acetaminophen, Aspirin, Caffeine	Dolgencorp, LLC	ANDA	Current
55910-374	DG Health migraine relief	Acetaminophen, Aspirin, Caffeine	Dolgencorp, LLC	ANDA	Current
55910-448	dg health migraine relief	acetaminophen, aspirin, caffeine	Dolgencorp Inc	ANDA	Current
56062-374	migraine relief	Acetaminophen, Aspirin, Caffeine	Publix Super Markets Inc	ANDA	Current
59779-374	migraine relief	acetaminophen, aspirin, caffeine	CVS Pharmacy	ANDA	Current
59779-374	migraine relief	acetaminophen, aspirin, caffeine	CVS Pharmacy	ANDA	Current
62011-0243	health mart migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
62011-0243	health mart migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
62011-0243	health mart migraine relief	Acetaminophen, Aspirin, Caffeine	McKesson	ANDA	Current
62011-0463	health mart migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
62011-0463	health mart migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
63981-374	kirkland signature migraine relief	Acetaminophen, Aspirin, Caffeine	Costco Wholesale Company	ANDA	Current
63981-374	kirkland signature migraine relief	Acetaminophen, Aspirin, Caffeine	Costco Wholesale Company	ANDA	Current
63981-699	kirkland signature migraine headache relief	Acetaminophen, Aspirin, Caffeine	Costco Wholesale Company	ANDA	Current
66715-9738	Lil Drug Store Headache Relief	Acetaminophen, Aspirin, and Caffeine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9738	Lil Drug Store Headache Relief	Acetaminophen, Aspirin, and Caffeine	Lil' Drug Store Products, Inc.	ANDA	Current
66715-9738	Lil Drug Store Headache Relief	Acetaminophen, Aspirin, and Caffeine	Lil' Drug Store Products, Inc.	ANDA	Current
68071-2723	good sense migraine formula	Acetaminophen, Aspirin, Caffeine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68391-536	berkley and jensen migraine formula	Acetaminophen, Aspirin, Caffeine	BJWC	ANDA	Current
69256-374	harris teeter migraine relief	Acetaminophen, Aspirin, Caffeine	Harris Teeter, LLC	ANDA	Current
70000-0247	Leader Migraine Relief	Acetaminophen, Aspirin, Caffeine	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70000-0247	Leader Migraine Relief	Acetaminophen, Aspirin, Caffeine	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8792	ORIG	2003-04-15