Aleve

Product NDC
0280-6050
11-digit product format
002806050
Labeler code
0280
Product ID
0280-6050_3271583e-5034-ed79-e063-6294a90a0b0e
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020204
Marketing category
NDA
Marketing start
2013-11-11
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
Brand name suffix
Caplets - Easy Open Arthritis Cap
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
94f09ef7-0695-4499-83c1-95f1e42baf98Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
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
0280-6050-01AleveCaplets - Easy Open Arthritis Cap100 in 1 BOTTLETABLET10019
0280-6050-02AleveCaplets - Easy Open Arthritis Cap24 in 1 BOTTLETABLET2419
0280-6050-03AleveCaplets - Easy Open Arthritis Cap130 in 1 BOTTLETABLET13019
0280-6050-03AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119
0280-6050-04AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119
0280-6050-04AleveCaplets - Easy Open Arthritis Cap150 in 1 BOTTLETABLET15019
0280-6050-05AleveCaplets - Easy Open Arthritis Cap110 in 1 BOTTLETABLET11019
0280-6050-06AleveCaplets - Easy Open Arthritis Cap90 in 1 BOTTLETABLET9019
0280-6050-27AleveCaplets - Easy Open Arthritis Cap270 in 1 BOTTLETABLET27019
0280-6050-27AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119
0280-6050-50AleveCaplets - Easy Open Arthritis Cap50 in 1 BOTTLETABLET5019
0280-6050-50AleveCaplets - Easy Open Arthritis Cap1 in 1 CARTONTABLET119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6050-01EA - Each0280-60502ffc0b90-ac14-42a9-b2cb-223e71589d4712022-02-07

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6050ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.]19Current NDC, Legacy NDC, 12 package rows20250411_94f09ef7-0695-4499-83c1-95f1e42baf98.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
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN94f09ef7-0695-4499-83c1-95f1e42baf9819
849574naproxen sodium 220 MG Oral TabletPSN94f09ef7-0695-4499-83c1-95f1e42baf9819
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD94f09ef7-0695-4499-83c1-95f1e42baf9819
849574naproxen sodium 220 MG Oral TabletSCD94f09ef7-0695-4499-83c1-95f1e42baf9819
849728Aleve 220 MG Oral TabletSY94f09ef7-0695-4499-83c1-95f1e42baf9819
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY94f09ef7-0695-4499-83c1-95f1e42baf9819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6050-0100280605001100 TABLET in 1 BOTTLE (0280-6050-01) 100 tablet2013-11-110000-00-00NoNoCurrent
0280-6050-020028060500224 TABLET in 1 BOTTLE (0280-6050-02) 24 tablet2020-06-110000-00-00NoNoCurrent
0280-6050-03002806050031 BOTTLE in 1 CARTON (0280-6050-03) / 130 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent
0280-6050-04002806050041 BOTTLE in 1 CARTON (0280-6050-04) / 150 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent
0280-6050-0500280605005110 TABLET in 1 BOTTLE (0280-6050-05) 110 tablet2021-07-010000-00-00NoNoCurrent
0280-6050-060028060500690 TABLET in 1 BOTTLE (0280-6050-06) 90 tablet2021-07-010000-00-00NoNoCurrent
0280-6050-27002806050271 BOTTLE in 1 CARTON (0280-6050-27) / 270 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent
0280-6050-50002806050501 BOTTLE in 1 CARTON (0280-6050-50) / 50 TABLET in 1 BOTTLE1 bottle2013-11-110000-00-00NoNoCurrent