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 35 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	STRATEGIC SOURCING SERVICES LLC	a2186895-944b-48cb-b3c2-eac208866c34	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	6a5d43c8-f4b7-4447-b2e1-53eb12208ef0	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Rising Pharma Holdings, Inc.	319ede76-110e-4902-a931-39a6d3b8c731	2024-10-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	FSA Store Inc.	ec6add55-f4a3-7818-e053-2a95a90aee04	2024-10-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	850b5ad8-8774-413c-ae38-022215a94f95	2024-10-16	Warnings	Name fallback generic name: ACETAMINOPHEN
365 whole foods market acetaminophen	ACETAMINOPHEN	Whole Foods Market, INC.	57f89574-98e5-40e5-8dd4-e868a668adaa	2024-10-15	Warnings	Name fallback generic name: ACETAMINOPHEN
PAIN RELIEF Regular Strength	ACETAMINOPHEN	AMERICAN SALES COMPANY	2e3eabc8-193b-4397-a43c-db838eb16e67	2024-10-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever	ACETAMINOPHEN	Walgreen Company	9e08eb38-7538-4fa0-a0e1-047ab6cb1680	2024-10-15	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief	ACETAMINOPHEN	PUBLIX SUPER MARKETS INC	9e779cc6-4641-6132-e053-2a95a90a3493	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	CHAIN DRUG CONSORTIUM	5c1a3081-ae25-4895-bf76-ebcbb9fc8072	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	9586e830-a285-4a07-8b34-969875442348	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
arthritis pain relief	ACETAMINOPHEN	Meijer	9f03fdb0-7dc0-376e-e053-2995a90ace05	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	5de40821-3218-4320-bf11-9493bf01d489	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1da0bd23-9f26-4913-9ebf-1fd8b0fb3bd3	2024-10-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Topcare Pain Relief	ACETAMINOPHEN	Topco Associates LLC	6036c15b-1168-4103-9471-6a74a2140e53	2024-10-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	46d9d8cd-e3db-492c-9386-7e8255beff64	2024-10-08	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	f6dc5576-9ba3-436c-87f5-8d0d6258adef	2024-10-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength	ACETAMINOPHEN	Navajo Manufacturing Company Inc.	86b6ac01-3866-4cd8-a1be-9babb6ff311b	2024-10-02	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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