FDA.reportPublic FDA data

Application 019872

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYLENOLACETAMINOPHENTABLET, EXTENDED RELEASE;ORAL650MGYesYes
002TYLENOLACETAMINOPHENTABLET, EXTENDED RELEASE;ORAL650MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019872-001TYLENOLACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08
N019872-002TYLENOLACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019872-001TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N019872-002TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019872-001TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08e64feba35796…
2022-09-29 23:25 UTC2022-09N019872-002TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019872-001TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019872-002TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019872-001TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019872-002TYLENOL650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol 8 HR Arthritis PainACETAMINOPHENKenvue Brands LLC3af22fc8-e4e0-4863-8696-6bc1257047cb2024-11-13WarningsExact identifier
application applno (NDA): 019872
application number: NDA019872
ndc (product): 50580-783
Tylenol 8HRACETAMINOPHENKenvue Brands LLC5d7d1300-bcb8-466a-880b-310b360ee1322024-11-07WarningsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50580-309Tylenol 8HRacetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-309Tylenol 8HRacetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-309Tylenol 8HRacetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57371SUPPL2019-01-29
57370SUPPL2019-01-29
45180SUPPL2016-08-26
34061SUPPL2015-01-05
1746SUPPL2014-12-30
11804SUPPL2014-12-15
1745SUPPL2014-12-15
11803SUPPL2014-03-27
1744SUPPL2014-03-07
34060SUPPL2014-01-09
34059SUPPL2014-01-09
11802SUPPL2014-01-09
1743SUPPL2013-12-26
19787SUPPL2013-03-28
20404SUPPL2012-06-28
41073SUPPL2012-04-13
20405SUPPL2012-01-27
1742SUPPL2012-01-03
1741SUPPL2010-05-17
1740SUPPL2010-05-12
11801SUPPL2009-06-29
1739SUPPL2009-06-23
1738SUPPL2004-11-08
1737SUPPL2004-04-20
19786SUPPL2004-03-30
1736SUPPL2003-08-14
34058SUPPL2003-06-08
34057SUPPL2003-06-08
19785SUPPL2003-06-08
19784SUPPL2003-06-08
11800SUPPL2003-06-08
1735SUPPL2003-06-08