Application 021317

Type: NDA
Sponsor: BAYER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	ASPIRIN	TABLET;ORAL	500MG	No	No

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
N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	ASPIRIN	500MG	TABLET / ORAL			2001-10-18

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021317-001	BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN	500MG	TABLET / ORAL	2001-10-18	`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 19 · 375 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ba0a9f2-062a-401e-82eb-54383a822366	2026-07-29	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable	ASPIRIN	Better Living Brands, LLC	7afce7b4-c86a-43f7-83cf-15ebffba2f35	2026-07-28	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	HAWAII REPACK, INC.	ac94cce3-9a39-41de-bb8b-10a5e5b8e83b	2026-07-17	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	DOLGENCORP, LLC	955484a6-2a7a-4b15-a9b4-e888ed5de04c	2026-07-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Geri-Care Pharmaceuticals, Corp	58941782-362d-4436-b365-e909bdbd29a2	2026-07-15	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Major Pharmaceuticals	44730dfb-5062-4015-924b-c30b6c2b19c2	2026-07-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Amerisource Bergen	2c5e80e8-a979-45fb-9297-8ff294280c25	2026-07-13	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Wal-Mart Stores Inc	8ae16aa2-54bc-4c1a-aa36-93524199a67b	2026-07-09	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regular Strength	ASPIRIN	FOODHOLD U.S.A., LLC	9e09b4fb-e015-45ea-8b1c-27faf65572aa	2026-07-09	Warnings	Name fallback generic name: ASPIRIN
Rapidol Aspirin	ASPIRIN	Pharmadel LLC	00d9ab0d-ff25-784f-e063-6294a90a8497	2026-07-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Trifecta Pharmaceuticals USA LLC	227cefca-acc4-41d0-e063-6394a90a35b9	2026-07-06	Warnings	Name fallback generic name: ASPIRIN
Bayer Genuine Aspirin	ASPIRIN	Select Consumer Group	3ca776c2-47ed-5107-e063-6394a90ac5df	2026-07-03	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Rugby Laboratories	f7ca9f4a-f8ef-46d2-9536-b69541e6653d	2026-07-02	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6	2026-07-02	Warnings	Name fallback generic name: ASPIRIN
Regular Strength Enteric coated aspirin	ASPIRIN	St. Mary's Medical Park Pharmacy	33733144-b26a-b4a3-e063-6294a90ae049	2026-07-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin 325 mg	ASPIRIN	Hi-Tech Nutraceuticals, LLC	b3426a9a-ea99-da30-e053-2995a90a1e4b	2026-07-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	St. Mary's Medical Park Pharmacy	0cca91cb-f05b-3cf8-e063-6394a90a9f79	2026-06-30	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Strategic Sourcing Services LLC	ea2ef485-429e-4c63-ba7b-0a6b32892ad2	2026-06-25	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	055d8420-c189-4a9e-acdc-21627935c8eb	2026-06-25	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Topco Associates, LLC	5f32cf74-dbea-496c-ba23-2040ea354f40	2026-06-25	Warnings	Name fallback generic name: ASPIRIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42096	ORIG	2001-10-18
15173	ORIG	2001-10-18
5011	ORIG	2001-10-18