Application 019872

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	TABLET, EXTENDED RELEASE;ORAL	650MG	Yes	Yes
002	TYLENOL	ACETAMINOPHEN	TABLET, EXTENDED RELEASE;ORAL	650MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019872-001	TYLENOL	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	1994-06-08
N019872-002	TYLENOL	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2001-01-11

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019872-001	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1994-06-08	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019872-002	TYLENOL	650MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2001-01-11	`3a93d1ddd44b…`

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tylenol 8 HR Arthritis Pain	ACETAMINOPHEN	Kenvue Brands LLC	3af22fc8-e4e0-4863-8696-6bc1257047cb	2024-11-13	Warnings	Exact identifier application applno (NDA): 019872 application number: NDA019872 ndc (product): 50580-783
Tylenol 8HR	ACETAMINOPHEN	Kenvue Brands LLC	5d7d1300-bcb8-466a-880b-310b360ee132	2024-11-07	Warnings	Exact identifier application applno (NDA): 019872 application number: NDA019872 ndc (product): 50580-309

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-309	Tylenol 8HR	acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-309	Tylenol 8HR	acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-309	Tylenol 8HR	acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-783	Tylenol 8 HR Arthritis Pain	Acetaminophen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57371	SUPPL	2019-01-29
57370	SUPPL	2019-01-29
45180	SUPPL	2016-08-26
34061	SUPPL	2015-01-05
1746	SUPPL	2014-12-30
11804	SUPPL	2014-12-15
1745	SUPPL	2014-12-15
11803	SUPPL	2014-03-27
1744	SUPPL	2014-03-07
34060	SUPPL	2014-01-09
34059	SUPPL	2014-01-09
11802	SUPPL	2014-01-09
1743	SUPPL	2013-12-26
19787	SUPPL	2013-03-28
20404	SUPPL	2012-06-28
41073	SUPPL	2012-04-13
20405	SUPPL	2012-01-27
1742	SUPPL	2012-01-03
1741	SUPPL	2010-05-17
1740	SUPPL	2010-05-12
11801	SUPPL	2009-06-29
1739	SUPPL	2009-06-23
1738	SUPPL	2004-11-08
1737	SUPPL	2004-04-20
19786	SUPPL	2004-03-30
1736	SUPPL	2003-08-14
34058	SUPPL	2003-06-08
34057	SUPPL	2003-06-08
19785	SUPPL	2003-06-08
19784	SUPPL	2003-06-08
11800	SUPPL	2003-06-08
1735	SUPPL	2003-06-08