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 9 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Enteric Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	a791d664-99fe-4cba-95cf-f49baedde326	2025-10-27	Warnings	Name fallback generic name: ASPIRIN
Ecotrin Regular Strength	ASPIRIN	Medtech Products Inc.	36cb530b-25b2-4f62-a25d-aa04360815a8	2025-10-23	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Meijer Distribution, Inc.	815a70e4-525c-4015-8d3b-83dbb979a66f	2025-10-17	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Athlete's Needs Inc	d8b5d5b4-44d2-4f8f-8c11-e4fc96504f59	2025-10-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	f1ce15a3-9824-4eb5-910a-39078165f385	2025-10-07	Warnings	Name fallback generic name: ASPIRIN
Chewable Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	cc865351-34e8-4e8e-b8bf-23336c45bc61	2025-10-02	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN 325 MG EC	ASPIRIN	Proficient Rx LP	9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77	2025-10-01	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	Marc Glassman, Inc.	14cb1d2d-95b8-447e-8d79-e6ec82c0e431	2025-10-01	Warnings	Name fallback generic name: ASPIRIN
Low Dose Chewable Aspirin	ASPIRIN	Bi-Mart	8b2a1a27-ee41-4960-87ee-aaca181ce8d2	2025-10-01	Warnings	Name fallback generic name: ASPIRIN
Enteric Coated Aspirin Regular Strength	ASPIRIN	Bryant Ranch Prepack	e05140fa-9766-4f97-bffc-e36a01b9d38f	2025-10-01	Warnings	Name fallback generic name: ASPIRIN
First Aid Direct Chewable Aspirin	ASPIRIN	Cintas Corp	ff6960f6-9f55-4f32-9ab5-9187724531e9	2025-09-25	Warnings	Name fallback generic name: ASPIRIN
Xpect Chewable Aspirin	ASPIRIN	Cintas Corporation	bddce374-1d35-4685-987d-4a4cc9994155	2025-09-25	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	Preferred Pharmaceuticals Inc.	29214eec-860c-43f0-83c6-9ed5a9f530af	2025-09-22	Warnings	Name fallback generic name: ASPIRIN
ASPIRIN	ASPIRIN	Kroger Company	bbee8ee4-e09d-3ba6-e053-2a95a90af647	2025-09-19	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated, Regular Strength	ASPIRIN	Walgreen Company	5e1484d3-5be1-40da-a3bf-fb19f7d27d45	2025-09-18	Warnings	Name fallback generic name: ASPIRIN
Aspirin 81 mg Low Dose	ASPIRIN	HEB	926fe7b6-9607-469f-912f-4019891067a9	2025-09-10	Warnings	Name fallback generic name: ASPIRIN
Bayer Genuine Aspirin	ASPIRIN	Unifirst First Aid Corporation	356e4ff4-a7f1-4a50-9b86-2555e232b300	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Medique at Home Aspirin	ASPIRIN	Unifirst First Aid Corporation	b5a469c1-9ab4-5bd7-e053-2995a90a86d1	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Medique Products Aspirin	ASPIRIN	Unifirst First Aid Corporation	9b28fed0-a993-ca72-e053-2995a90ac7fd	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Unishield Aspirin	ASPIRIN	Unishield	ba106b20-32ac-df90-e053-2995a90adaef	2025-09-09	Warnings	Name fallback generic name: ASPIRIN

Reported adverse events (FAERS/openFDA)#

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