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 18 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare childrens pain and fever	ACETAMINOPHEN	Topco Associates LLC	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	2025-12-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	33599f18-5f49-4f22-8a77-a072115763ef	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	005e299e-aa84-49d9-bbca-12236f865a27	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d4c32e70-778a-4d66-b9d0-03944a528421	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Arthritis Pain	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	cd3a7094-ddb5-4583-a1bc-dc6ce280418c	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	5a80cb17-7731-4457-acd3-64cf4accf862	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d11a7412-a543-0e34-e053-2995a90afd63	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	02e3798f-86d9-64b4-e063-6294a90a29de	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	f7e87eac-59fb-4a72-b5c6-02953112be6a	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	355a094c-bed9-4959-8cf0-619f0e246105	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	fac4e0c6-684f-45a1-99f2-de4de4017cc8	2025-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	2e30754a-42f7-4da2-944c-be61cee47b43	2025-12-10	Warnings	Name fallback generic name: ACETAMINOPHEN
MAX relief junior	ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	ff1f6f82-0c7c-4e3f-a2bd-3185e16fa770	2025-12-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad34f4-4e66-f371-e063-6394a90ae76a	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	LIDL US LLC	ec543339-20ab-2cba-e053-2995a90ac740	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	c57c10fc-f182-4153-8974-ef359a5f5ac1	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Rapid Release Gelcaps Extra Strength	ACETAMINOPHEN	Safeway	c830d1ac-c4c5-4eb1-98bb-22707cb6db91	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f65203a2-64f0-4138-97e4-6eab99194178	2025-12-09	Warnings	Name fallback generic name: ACETAMINOPHEN
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN	ACETAMINOPHEN	BJWC	e27b6637-ef32-44b5-a531-b6617d02fbbf	2025-12-08	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS	3f9f1740-9e8b-6a2d-e063-6294a90a67cb	2025-12-06	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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