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 25 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADWE Childrens Pain Fever	ACETAMINOPHEN	RARITAN PHARMACEUTICALS INC	79a3232f-0211-4c8a-acee-4f87e06ffc26	2025-07-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Walmart Inc.	24d191ca-a0c4-e1a8-e063-6394a90a7a2a	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3005d0c-424e-0ab3-e053-2995a90a1c10	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397fa6e1-37b2-8f51-e063-6394a90a7b94	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	39800c27-f39f-cd60-e063-6394a90acd55	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397f2b63-733e-5b44-e063-6394a90a9718	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Berkley and Jensen Pain Relief	ACETAMINOPHEN	BJWC	d3ee3341-93b8-487c-921e-2892d213efbb	2025-07-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Up and Up Childrens acetaminophen	ACETAMINOPHEN	Target Corporation	25a476a4-9969-49b3-94bf-b076bada4cea	2025-07-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength Caplet	ACETAMINOPHEN	Jones Healthcare Group - Packaging Services, Inc	fba711c1-4e69-49b0-8994-97c455aebcb2	2025-07-09	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	L. Perrigo Company	af7ae548-38ad-41d5-b1cb-761cd2e386d3	2025-07-08	Warnings	Name fallback generic name: ACETAMINOPHEN
topcare pain relief	ACETAMINOPHEN	Topco Associates LLC	6aca88df-d3b5-4a60-b23b-1e66dc41ee7b	2025-07-08	Warnings	Name fallback generic name: ACETAMINOPHEN
equate childrens pain and fever	ACETAMINOPHEN	Wal-Mart Stores Inc	f15037a5-4e43-4dd6-93b8-b37a1cc22cd6	2025-07-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen Oral Liquid Grape Flavor	ACETAMINOPHEN	AARNA USA INC.	39347f5d-2d3c-0c23-e063-6294a90a3a46	2025-07-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	be841460-98b4-4448-a494-09ff161fd131	2025-07-02	Warnings	Name fallback generic name: ACETAMINOPHEN
FeverAll	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	8970b91b-5f3c-4764-9e23-25dcb398d0a7	2025-07-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	11c9712d-c3b2-49cd-9c2b-0f57190c954e	2025-07-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Childrens	ACETAMINOPHEN	CVS Pharmacy	f6bbce1c-9790-4ca4-847f-579c594ffe0b	2025-07-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	WALGREENS	07d2e322-2465-79e5-e063-6294a90a5ea4	2025-06-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Arthritis Pain	ACETAMINOPHEN	DISCOUNT DRUG MART	973bcf75-8c45-ea16-e053-2a95a90aad63	2025-06-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	66c0cf26-357b-4722-9100-3b86d507a8cd	2025-06-30	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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