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 28 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	23780dab-91d8-434f-9342-f5f1ba0a3c0a	2025-04-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Foster and Thrive Pain Reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	0a7d82f8-7615-4cef-b245-94b186f3c8fa	2025-04-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Gland Pharma Limited	db5d4cf8-762a-4111-971e-91c704bc3643	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	bdc466c9-d9ae-4293-b7ea-46fb517661c6	2025-04-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	2025-04-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength	ACETAMINOPHEN	Aurex Laboratories Limited Liability Company	948c5826-6f35-484d-bb3f-cecf6a4b5c13	2025-03-31	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	281a530b-c759-50eb-e063-6394a90abb4f	2025-03-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Regular strength	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	4181efc2-d183-410c-b647-233444c57e32	2025-03-20	Warnings	Name fallback generic name: ACETAMINOPHEN
CounterAct Pain	ACETAMINOPHEN	Melaleuca, Inc.	7faf76b4-7f25-377d-e053-2a91aa0a19d4	2025-03-20	Boxed warning, Warnings	Name fallback generic name: ACETAMINOPHEN
8HR Arthritis Pain	ACETAMINOPHEN	FSA STORE INC.	06446e9a-0e83-0623-e063-6294a90ac403	2025-03-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4	2025-03-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Major Extra Strength Acetaminophen Liquid	ACETAMINOPHEN	Major Pharmaceuticals	2f3af4dd-45d5-87b4-e063-6294a90ab3cc	2025-02-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	f9de7c2f-016b-4f40-8b5e-141ad194be97	2025-02-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Acetaminophen PM Extra Strength	ACETAMINOPHEN	Genexa Inc.	d82cf6f3-a291-ca2b-e053-2a95a90a6de1	2025-02-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen	ACETAMINOPHEN	Advagen Pharma Limited	8b9456c9-a56b-4748-adb8-c66d6bf072e8	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Childrens Acetaminophen	ACETAMINOPHEN	Genexa Inc.	d89fd9d8-d88e-3968-e053-2a95a90afc5f	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	debfa787-7a48-48b5-94b0-612820524032	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	b16e5dcf-b290-4ff2-a150-4b875647ec9a	2025-02-19	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	2025-02-18	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	c830320e-72ba-48ff-a4cd-250ac5650bf0	2025-02-18	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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