Home NDC 0280-6092-10 Aleve Back and Muscle Pain
Product NDC 0280-6092
Requested package NDC 0280-6092-10
11-digit product format 002806092
Labeler code 0280
Product ID 0280-6092_4526b594-84b6-b981-e063-6294a90a1aed
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA020204
Marketing category NDA
Marketing start 2018-01-26
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Back and Muscle Pain
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-6092 ALEVE BACK AND MUSCLE PAIN (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.] 18 Current NDC, Legacy NDC, 23 package rows 20221007_6376e1b8-52c4-0519-e053-2a91aa0af35f.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 0280-6092-10 00280609210 1 BOTTLE in 1 CARTON (0280-6092-10) > 100 TABLET in 1 BOTTLE 1 bottle 2018-01-26 2023-09-30 No No Current