Application 016030

Type: NDA
Sponsor: BAYER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	8-HOUR BAYER	ASPIRIN	TABLET, EXTENDED RELEASE;ORAL	650MG	No	No
002	MEASURIN	ASPIRIN	TABLET, EXTENDED RELEASE;ORAL	650MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016030-001	8-HOUR BAYER	ASPIRIN	650MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982
N016030-002	MEASURIN	ASPIRIN	650MG	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016030-001	8-HOUR BAYER	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016030-002	MEASURIN	650MG	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`

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 4 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin Low Dose	ASPIRIN	DOLGENCORP, LLC	a7e27000-a26b-46c2-823e-663f4e76db74	2026-05-11	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	Wal-Mart Stores Inc	093e0458-9975-456f-8950-8273c8890b3c	2026-05-11	Warnings	Name fallback generic name: ASPIRIN
Aspirin Regular Strength	ASPIRIN	Rugby Laboratories	939fce7e-55df-4dc5-916b-a533448e962f	2026-05-08	Warnings	Name fallback generic name: ASPIRIN
Extra Strength Aspirin	ASPIRIN	HHH Pharmaceuticals	90d457bb-79a7-4759-8ee7-6abffbe1e549	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81mg Enteric Coated	ASPIRIN	HHH Pharmaceuticals	d81aec73-c7c1-4c52-80f6-fb0e32caf7aa	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Better Living Brands, LLC	5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Geiss, Destin & Dunn Inc.	b8f6e486-5332-4c46-ab6c-7de04c91c60b	2026-05-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Chewable Orange	ASPIRIN	Major Pharmaceuticals	4ba6eed3-004a-4576-b7f7-685fae49cf6a	2026-05-04	Warnings	Name fallback generic name: ASPIRIN
Medique at Home Aspirin	ASPIRIN	Sportpharm LLC	0f2aa75e-534f-478b-811e-fb492b7af9bb	2026-04-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Health Pharma USA LLC	503868bb-48e0-b718-e063-6394a90a9c5b	2026-04-24	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low Dose	ASPIRIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	23b29044-6389-42ea-839a-5351557a6ce3	2026-04-23	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	07edcb31-d31d-4607-98c3-dcb1e062cc70	2026-04-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	CVS PHARMACY	904a2b21-d911-40c3-9e4b-59543ea5be4f	2026-04-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg	ASPIRIN	Preferred Pharmaceuticals Inc.	ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e	2026-04-20	Warnings	Name fallback generic name: ASPIRIN
Aspirin NSAID	ASPIRIN	Valu Merchandisers Company	0cc46a81-54c9-44b7-b384-79d25255eff2	2026-04-17	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Valu Merchandisers Company	c9e384e5-fa9b-4c75-b5e3-16eb8db662ef	2026-04-16	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Name fallback generic name: ASPIRIN
Bayer Genuine Aspirin	ASPIRIN	Navajo Manufacturing Company Inc.	f6f2ce71-5728-aefb-e053-6394a90a20e4	2026-04-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	HyVee Inc	3730ee46-b241-44eb-94fa-52b9d12a9c35	2026-04-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Walgreen Company	82cc404b-fcf5-4e48-ab1a-09d8c47f9e04	2026-04-08	Warnings	Name fallback generic name: ASPIRIN

Reported adverse events (FAERS/openFDA)#

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