Home NDC 0280-6020 Aleve
Product NDC 0280-6020
11-digit product format 002806020
Labeler code 0280
Product ID 0280-6020_4526be49-a72d-1db7-e063-6394a90a1937
Type HUMAN OTC DRUG
Nonproprietary name NAPROXEN SODIUM
Dosage form TABLET, COATED
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA020204
Marketing category NDA
Marketing start 2002-08-01
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 Gelcaps
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-6020-02 AleveGelcaps 1 in 1 CARTON TABLET, COATED 1 16 0280-6020-02 AleveGelcaps 90 in 1 BOTTLE TABLET, COATED 90 16 0280-6020-16 AleveGelcaps 160 in 1 BOTTLE TABLET, COATED 160 16 0280-6020-20 AleveGelcaps 20 in 1 BOTTLE TABLET, COATED 20 16 0280-6020-20 AleveGelcaps 1 in 1 CARTON TABLET, COATED 1 16 0280-6020-40 AleveGelcaps 40 in 1 BOTTLE TABLET, COATED 40 16 0280-6020-40 AleveGelcaps 1 in 1 CARTON TABLET, COATED 1 16 0280-6020-80 AleveGelcaps 80 in 1 BOTTLE TABLET, COATED 80 16 0280-6020-80 AleveGelcaps 1 in 1 CARTON TABLET, COATED 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 naproxen ACTIVE MOIETY 57Y76R9ATQ ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-6020 ALEVE GELCAPS (NAPROXEN SODIUM) TABLET, COATED [BAYER HEALTHCARE LLC.] 15 Current NDC, Legacy NDC, 9 package rows 20241208_0ad8bbb9-dd5f-4273-b085-ee3e5ed22613.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 0280-6020-02 00280602002 1 BOTTLE in 1 CARTON (0280-6020-02) / 90 TABLET, COATED in 1 BOTTLE 1 bottle 2022-10-20 0000-00-00 No No Current 0280-6020-16 00280602016 160 TABLET, COATED in 1 BOTTLE (0280-6020-16) 2019-09-26 0000-00-00 No No Current 0280-6020-20 00280602020 20 in 1 BOTTLE Historical 0280-6020-40 00280602040 40 in 1 BOTTLE Historical 0280-6020-80 00280602080 80 in 1 BOTTLE Historical