Aleve

Product NDC
0280-6010
11-digit product format
002806010
Labeler code
0280
Product ID
0280-6010_4526b265-424f-3e71-e063-6294a90a21a8
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020204
Marketing category
NDA
Marketing start
2002-07-26
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Aleve
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9TN87S3A3CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849574Internal RxNorm lookup
849728Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00ef5b30-71d0-4cb4-84a3-48c67d1cea2aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-6010-01Aleve100 in 1 BOTTLETABLET10019
0280-6010-01Aleve1 in 1 CARTONTABLET119
0280-6010-02Aleve130 in 1 BOTTLETABLET13019
0280-6010-02Aleve1 in 1 CARTONTABLET119
0280-6010-03Aleve1 in 1 CARTONTABLET119
0280-6010-03Aleve150 in 1 BOTTLETABLET15019
0280-6010-04Aleve1 in 1 CARTONTABLET119
0280-6010-04Aleve36 in 1 BOTTLETABLET3619
0280-6010-05Aleve65 in 1 BOTTLETABLET6519
0280-6010-05Aleve1 in 1 CARTONTABLET119
0280-6010-06Aleve225 in 1 BOTTLETABLET22519
0280-6010-07Aleve270 in 1 BOTTLETABLET27019
0280-6010-09Aleve90 in 1 BOTTLETABLET9019
0280-6010-10Aleve1 in 1 TRAYTABLET119
0280-6010-10Aleve10 in 1 BOTTLETABLET1019
0280-6010-24Aleve24 in 1 BOTTLETABLET2419
0280-6010-24Aleve1 in 1 CARTONTABLET119
0280-6010-50Aleve1 in 1 CARTONTABLET119
0280-6010-50Aleve50 in 1 BOTTLETABLET5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6010-01EA - Each0280-601083c66b1d-3796-4820-890f-9da653456af512021-11-09
0280-6010-24EA - Each0280-6010d8e1b554-21ac-4716-bc8b-b9c4727172eb12021-07-15
0280-6010-50EA - Each0280-60104c384d3d-abd6-4d6c-aee2-9205f4b0101d12023-07-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6010ALEVE (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.]18Current NDC, Legacy NDC, 19 package rows20241208_00ef5b30-71d0-4cb4-84a3-48c67d1cea2a.zip

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
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
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.a3745850-3e32-4884-b315-161bcb9996ed2025-12-04Exact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve GelcapsNAPROXEN SODIUMBayer HealthCare LLC.acea54a2-5a92-428e-a778-bb4f9d6767822025-12-04Exact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve GelcapsNAPROXEN SODIUMBayer HealthCare LLC.0ad8bbb9-dd5f-4273-b085-ee3e5ed226132025-12-04WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
Aleve Easy Open Arthritis CapNAPROXEN SODIUMBayer HealthCare LLC.3c0ddd25-5a9a-4628-a971-65fe2a9775b52025-12-04WarningsExact identifier
application applno (NDA): 020204
application number: NDA020204
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN00ef5b30-71d0-4cb4-84a3-48c67d1cea2a19
849574naproxen sodium 220 MG Oral TabletPSN00ef5b30-71d0-4cb4-84a3-48c67d1cea2a19
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD00ef5b30-71d0-4cb4-84a3-48c67d1cea2a19
849574naproxen sodium 220 MG Oral TabletSCD00ef5b30-71d0-4cb4-84a3-48c67d1cea2a19
849728Aleve 220 MG Oral TabletSY00ef5b30-71d0-4cb4-84a3-48c67d1cea2a19
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY00ef5b30-71d0-4cb4-84a3-48c67d1cea2a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6010-01002806010011 BOTTLE in 1 CARTON (0280-6010-01) / 100 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-02002806010021 BOTTLE in 1 CARTON (0280-6010-02) / 130 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-03002806010031 BOTTLE in 1 CARTON (0280-6010-03) / 150 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-04002806010041 BOTTLE in 1 CARTON (0280-6010-04) / 36 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-05002806010051 BOTTLE in 1 CARTON (0280-6010-05) / 65 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-0600280601006225 TABLET in 1 BOTTLE (0280-6010-06) 225 tablet2002-07-260000-00-00NoNoCurrent
0280-6010-0700280601007270 TABLET in 1 BOTTLE (0280-6010-07) 270 tablet2002-07-260000-00-00NoNoCurrent
0280-6010-090028060100990 TABLET in 1 BOTTLE (0280-6010-09) 90 tablet2002-07-260000-00-00NoNoCurrent
0280-6010-10002806010101 BOTTLE in 1 TRAY (0280-6010-10) / 10 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-1100280601011110 TABLET in 1 BOTTLE (0280-6010-11) 110 tablet2002-07-260000-00-00NoNoCurrent
0280-6010-24002806010241 BOTTLE in 1 CARTON (0280-6010-24) / 24 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent
0280-6010-50002806010501 BOTTLE in 1 CARTON (0280-6010-50) / 50 TABLET in 1 BOTTLE1 bottle2002-07-260000-00-00NoNoCurrent