Home NDC 0280-6000 Aleve
Product NDC 0280-6000
11-digit product format 002806000
Labeler code 0280
Product ID 0280-6000_4526b744-fa15-0f7b-e063-6394a90a916e
Type HUMAN OTC DRUG
Nonproprietary name NAPROXEN SODIUM
Dosage form TABLET
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA020204
Marketing category NDA
Marketing start 2014-02-26
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020204-002 ALEVE NAPROXEN SODIUM 220MG TABLET / ORAL RLD, RS 1994-01-11
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020204-002 ALEVE EQ 200MG BASE TABLET / ORAL RLD, RS 1994-01-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020204-002 ALEVE EQ 200MG BASE TABLET / ORAL RLD, RS 1994-01-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020204-002 ALEVE 220MG TABLET / ORAL RLD, RS 1994-01-11 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Aleve
Brand name suffix Caplets
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN SODIUM 220 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849574 Internal RxNorm lookup 849728 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALEVE (NAPROXEN SODIUM) TABLET [R J GENERAL CORPORATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-6000 ALEVE CAPLETS (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.] 16 Current NDC, Legacy NDC, 33 package rows 20221201_a3745850-3e32-4884-b315-161bcb9996ed.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-6000-01 00280600001 24 TABLET in 1 BOTTLE (0280-6000-01) 24 tablet 2014-02-26 0000-00-00 No No Current 0280-6000-02 00280600002 1 BOTTLE in 1 CARTON (0280-6000-02) / 200 TABLET in 1 BOTTLE 1 bottle 2014-03-26 0000-00-00 No No Current 0280-6000-03 00280600003 1 BOTTLE in 1 CARTON (0280-6000-03) / 130 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-04 00280600004 1 BOTTLE in 1 CARTON (0280-6000-04) / 225 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-05 00280600005 1 BOTTLE in 1 CARTON (0280-6000-05) / 36 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-06 00280600006 1 BLISTER PACK in 1 CARTON (0280-6000-06) / 6 TABLET in 1 BLISTER PACK 1 blister pack 2014-02-26 0000-00-00 No No Current 0280-6000-07 00280600007 48 TABLET in 1 POUCH (0280-6000-07) 48 tablet 2014-02-26 0000-00-00 No No Current 0280-6000-08 00280600008 1 BOTTLE in 1 CARTON (0280-6000-08) / 65 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-09 00280600009 1 TABLET in 1 POUCH (0280-6000-09) 1 tablet 2020-07-01 0000-00-00 No No Current 0280-6000-10 00280600010 1 BOTTLE in 1 CARTON (0280-6000-10) > 100 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-12 00280600012 1 BOTTLE in 1 CARTON (0280-6000-12) / 90 TABLET in 1 BOTTLE 1 bottle 2021-07-01 0000-00-00 No No Current 0280-6000-14 00280600014 60 TABLET in 1 POUCH (0280-6000-14) 60 tablet 2021-07-31 0000-00-00 No No Current 0280-6000-15 00280600015 1 BOTTLE in 1 CARTON (0280-6000-15) > 150 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-16 00280600016 1 TABLET in 1 POUCH (0280-6000-16) 1 tablet 2021-07-01 0000-00-00 Yes No Current 0280-6000-24 00280600024 1 BOTTLE in 1 CARTON (0280-6000-24) / 24 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-27 00280600027 270 TABLET in 1 BOTTLE (0280-6000-27) 270 tablet 2021-07-01 0000-00-00 No No Current 0280-6000-32 00280600032 1 BOTTLE in 1 CARTON (0280-6000-32) / 320 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-50 00280600050 1 BOTTLE in 1 CARTON (0280-6000-50) / 50 TABLET in 1 BOTTLE 1 bottle 2014-02-26 0000-00-00 No No Current 0280-6000-70 00280600070 1 BOTTLE in 1 CARTON (0280-6000-70) / 150 TABLET in 1 BOTTLE 1 bottle 2016-03-18 No No Current 0280-6000-75 00280600075 180 in 1 BOTTLE Historical