FDA.reportPublic FDA data

Application 020204

Type
NDA
Sponsor
BAYER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ALEVENAPROXEN SODIUMTABLET;ORAL220MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020204-002ALEVENAPROXEN SODIUM220MGTABLET / ORALRLD, RS1994-01-11

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020204-002ALEVEEQ 200MG BASETABLET / ORALRLD, RS1994-01-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020204-002ALEVEEQ 200MG BASETABLET / ORALRLD, RS1994-01-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11cb3db0bc1861…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve CapletsNAPROXEN SODIUMSelect Consumer Group3ca84972-f8c9-1881-e063-6294a90a90702026-07-03WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
AleveNAPROXEN SODIUMNavajo Manufacturing Company Inc.590f3be2-20df-4643-9114-e7ed4cf9155c2026-04-08WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.02941928-128a-2c88-e063-6294a90ac6ba2026-03-12WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve Headache PainNAPROXEN SODIUMBayer HealthCare LLCc69f4926-c5cd-63a0-e053-2a95a90a2ca62025-12-04WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-0041
AleveNAPROXEN SODIUMBayer HealthCare LLC.00ef5b30-71d0-4cb4-84a3-48c67d1cea2a2025-12-04Exact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6010
Aleve Back and Muscle PainNAPROXEN SODIUMBayer HealthCare LLC.6376e1b8-52c4-0519-e053-2a91aa0af35f2025-12-04Exact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6092
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.a3745850-3e32-4884-b315-161bcb9996ed2025-12-04Exact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6000
Aleve GelcapsNAPROXEN SODIUMBayer HealthCare LLC.acea54a2-5a92-428e-a778-bb4f9d6767822025-12-04Exact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6070
Aleve GelcapsNAPROXEN SODIUMBayer HealthCare LLC.0ad8bbb9-dd5f-4273-b085-ee3e5ed226132025-12-04WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6020
Aleve Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.3c0ddd25-5a9a-4628-a971-65fe2a9775b52025-12-04WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6060
AleveNAPROXEN SODIUMR J General Corporation46e7b298-9e19-49b6-be71-e4fdcb09a5d42025-11-17WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Bayer AleveNAPROXEN SODIUMUnifirst First Aid Corporation5dd569ca-d03e-410c-af98-4732c823d5952025-09-09WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve Headache PainNAPROXEN SODIUMBayer HealthCare LLC.3ba28e47-1294-bec7-e063-6294a90ac80a2025-08-05WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve Caplets - Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.94f09ef7-0695-4499-83c1-95f1e42baf982025-04-10WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
ndc (product): 0280-6050
AleveNAPROXEN SODIUMBayer HealthCare LLC.31bad2d9-c0bb-7f20-e063-6294a90acb172025-04-01WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve Back and Muscle PainNAPROXEN SODIUMBayer HealthCare LLC.31bae77b-42dd-94eb-e063-6294a90ad5702025-04-01WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve Headache PainNAPROXEN SODIUMBayer HealthCare LLC.31baf777-c805-21ea-e063-6394a90abbd82025-04-01WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
AleveNAPROXEN SODIUMLil' Drug Store Products, Incabfcf13e-6eba-49e2-8ebf-4593487142702025-01-06WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Bayer AleveNAPROXEN SODIUMAcme United Corporationf758201c-28b8-5357-e053-6394a90a1e5d2023-03-20WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
AleveNAPROXEN SODIUMNavajo Manufacturing Company Inc60637aeb-deb6-4747-e053-2a91aa0ad00b2023-03-01WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 122 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0280-0041Aleve Headache PainNaproxen SodiumBayer HealthCare LLCNDACurrent
0280-0041Aleve Headache PainNaproxen SodiumBayer HealthCare LLCNDACurrent
0280-0270MenstridolNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-0270MenstridolNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-0270MenstridolNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6000AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6010AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6020AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6050AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6060AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6070AleveNAPROXEN SODIUMBayer HealthCare LLC.NDACurrent
0280-6092Aleve Back and Muscle PainNaproxen SodiumBayer HealthCare LLC.NDACurrent
0280-6092Aleve Back and Muscle PainNaproxen SodiumBayer HealthCare LLC.NDACurrent
0280-6092Aleve Back and Muscle PainNaproxen SodiumBayer HealthCare LLC.NDACurrent
0280-6092Aleve Back and Muscle PainNaproxen SodiumBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85325SUPPL 2026-03-12
85324SUPPL 2026-03-12
82098SUPPL 2025-05-01
82097SUPPL 2025-05-01
79607SUPPL 2024-09-16
79604SUPPL 2024-09-16
74486SUPPL 2023-06-13
74475SUPPL 2023-06-13
70520SUPPL2022-03-15
70482SUPPL2022-03-11
67170SUPPL2021-04-23
67108SUPPL2021-04-19
67107SUPPL2021-04-19
67106SUPPL2021-04-19
67105SUPPL2021-04-19
66989SUPPL2021-04-05
66330SUPPL2021-02-23
65809SUPPL2021-01-04
65808SUPPL2021-01-04
65807SUPPL2021-01-04
65806SUPPL2021-01-04
65114SUPPL2020-11-02
62894SUPPL2020-05-11
62893SUPPL2020-05-11
62672SUPPL2020-04-24
62671SUPPL2020-04-24
62030SUPPL2020-03-04
62029SUPPL2020-03-04
59666SUPPL2019-08-13
59667SUPPL2019-08-12
59439SUPPL2019-07-24
59438SUPPL2019-07-24
59234SUPPL2019-07-05
59233SUPPL2019-07-05
58721SUPPL2019-05-15
58720SUPPL2019-05-15
58719SUPPL2019-05-15
57513SUPPL2019-02-13
57455SUPPL2019-02-06
57119SUPPL2019-01-04
57117SUPPL2019-01-04
55928SUPPL2018-10-15
55737SUPPL2018-10-01
55367SUPPL2018-08-30
55366SUPPL2018-08-30
55112SUPPL2018-08-03
55007SUPPL2018-07-26
54623SUPPL2018-06-20
54622SUPPL2018-06-20
54596SUPPL2018-06-14
54588SUPPL2018-06-14
53588SUPPL2018-04-01
53578SUPPL2018-04-01
53510SUPPL2018-03-29
53499SUPPL2018-03-28
49825SUPPL2017-09-21
49797SUPPL2017-09-19
49541SUPPL2017-08-25
49535SUPPL2017-08-24
12317SUPPL2016-06-17
34365SUPPL2014-01-14
34366SUPPL2013-11-21
24572SUPPL2013-04-23
2166SUPPL2013-02-08
24571SUPPL2013-01-07
24570SUPPL2012-03-19
24569SUPPL2012-03-19
24568SUPPL2011-04-11
2165SUPPL2011-02-24
24567SUPPL2010-11-08
24566SUPPL2009-04-21
2164SUPPL2008-11-26
2163SUPPL2006-01-20
23572ORIG2005-07-28
12316SUPPL2005-05-05
2162SUPPL2005-05-05
24565SUPPL2004-03-24
2161SUPPL2002-08-30
2160SUPPL2002-03-19
24564SUPPL2001-03-06