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 10 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Travel Savvy Aspirin	ASPIRIN	Bellegrove Medical Supply, Inc.	bae80044-ad7f-3bf5-e053-2995a90a42f9	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
McKesson Aspirin	ASPIRIN	McKesson Medical-Surgical	dabd741e-e11c-52c1-e053-2a95a90a91d5	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Direct Safety Aspirin	ASPIRIN	Direct Safety	ba9ba697-d3df-49d7-e053-2a95a90af406	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
ULINE Aspirin	ASPIRIN	ULINE	9b2b053c-11e7-8169-e053-2995a90ae336	2025-09-09	Warnings	Name fallback generic name: ASPIRIN
Green Guard Chewable Aspirin 81 mg	ASPIRIN	Unifirst First Aid Corporaiton	173a53ca-b6ea-2042-e063-6294a90a8437	2025-09-08	Warnings	Name fallback generic name: ASPIRIN
Medique Products Chewable Low Dose Aspirin	ASPIRIN	Unifirst First Aid Corporation	17009501-674d-c839-e063-6294a90a59fa	2025-09-08	Warnings	Name fallback generic name: ASPIRIN
Thompson Aspirin	ASPIRIN	Thompson	9623d9c6-f241-bf4a-e053-2a95a90a4eb5	2025-09-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin Enteric Coated Low Dose	ASPIRIN	Walgreen Company	b11a4c4e-374c-403e-a757-5e9700f9f03b	2025-08-27	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose Safety Coated	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	577035a5-88ab-431c-8598-7a19dd633fe9	2025-08-26	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	2f32b096-d29a-c7c7-e063-6294a90a2bbe	2025-08-22	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	PROSTAT FIRST AID	3bdb9d89-9000-69f9-e063-6294a90a0c97	2025-08-08	Warnings	Name fallback generic name: ASPIRIN
Aspi-Cor	ASPIRIN	L.N.K. International, Inc.	9f919a48-ffd8-49fa-b6fd-ec71cc12e64b	2025-08-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	8575ef9d-2eae-412a-a252-82b03f4d5275	2025-08-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	A-S Medication Solutions	7a91b1df-8d6d-4205-9822-bc4d800555f7	2025-08-08	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	A-S Medication Solutions	44b8c203-37c5-425e-9110-f7eb614f9c2d	2025-08-08	Warnings	Name fallback generic name: ASPIRIN
Low Dose Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	c46688ec-e976-4f76-9265-645f59970ff5	2025-08-06	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Marlex Pharmaceuticals Inc.	cc7013ea-cf30-6f59-e053-2a95a90a1148	2025-08-05	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Proficient Rx LP	2ef0757a-fe5f-47de-906a-a4d47a0d0534	2025-08-01	Warnings	Name fallback generic name: ASPIRIN
Aspirin	ASPIRIN	Bi-Mart	cc5db55a-a2b0-48f4-802b-9e5e94fd9ceb	2025-08-01	Warnings	Name fallback generic name: ASPIRIN
Coated Aspirin	ASPIRIN	L.N.K. International, Inc.	e077fe14-62bb-462b-bfa3-8a83c06c22f1	2025-07-11	Warnings	Name fallback generic name: ASPIRIN

Reported adverse events (FAERS/openFDA)#

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