Application 017756

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TYLENOL	ACETAMINOPHEN	SUPPOSITORY;RECTAL	650MG	No	No
002	TYLENOL	ACETAMINOPHEN	SUPPOSITORY;RECTAL	120MG	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
N017756-001	TYLENOL	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL		Approved before 1982
N017756-002	TYLENOL	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL		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	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017756-001	TYLENOL	650MG	SUPPOSITORY / RECTAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017756-002	TYLENOL	120MG	SUPPOSITORY / RECTAL	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 31 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6fee238-0b6f-cb84-e053-2995a90a361b	2024-12-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	Marc Glassman, Inc.	43bf297f-2832-424f-a013-4bfa1d6c03e6	2024-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	5a68ab98-720c-479a-a60a-4e594add6c09	2024-12-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	TopCo Associates LLC	ecd6df7e-e7e2-446b-85ef-25971281fe31	2024-12-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	L. Perrigo Company	c6b79501-d08b-4430-9545-70da5f545975	2024-12-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	2d98e390-4f2a-41cc-b307-3d2f6a3700dd	2024-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	a891896d-c9fa-4448-915a-e6b531157d22	2024-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	SAFEWAY	d2d15e06-e9eb-3d2b-e053-2995a90a1cec	2024-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	TopCo Associates LLC	c2d33352-431c-4683-a4fa-a54437e7b8d2	2024-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	TopCo Associates LLC	bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb	2024-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc	c4473ee6-4e01-1ec2-e053-2995a90ac513	2024-12-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Chewable Acetaminophen	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	22f63d62-c941-5b8f-e063-6394a90aeecd	2024-11-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a7b6318-b7d6-31b1-e053-2991aa0abf25	2024-11-28	Warnings	Name fallback generic name: ACETAMINOPHEN
First Aid Only Extra-Strength Non-Aspirin	ACETAMINOPHEN	Acme United Corporation	6891d57a-10a6-53de-e053-2a91aa0ac7c2	2024-11-26	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	06eabf4b-f8c0-439a-acf1-aa6e3075c717	2024-11-25	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Name fallback generic name: ACETAMINOPHEN
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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