Home NDC 0280-0105 Aleve liquid gels
Product NDC 0280-0105
11-digit product format 002800105
Labeler code 0280
Product ID 0280-0105_2766b060-5c1b-41fb-b8ca-cfb1a021b64e
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bayer Healthcare LLC
Application ANDA214463
Marketing category ANDA
Marketing start 2023-12-01
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 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 A214463-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10
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.
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 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214463-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL 2023-01-10 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Aleve liquid gels
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 1112231 Internal RxNorm lookup 1112233 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 0280-0105-01 Aleve liquid gels 120 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 120 2 0280-0105-02 Aleve liquid gels 160 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 160 2 0280-0105-03 Aleve liquid gels 20 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 20 2 0280-0105-04 Aleve liquid gels 50 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 50 2 0280-0105-05 Aleve liquid gels 80 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 80 2 0280-0105-06 Aleve liquid gels 80 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 80 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0105 ALEVE LIQUID GELS (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC] 2 Current NDC, 6 package rows 20240510_a0587c73-d297-462d-a0ef-750cb324486e.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0280-0105-01 00280010501 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-01) 2024-06-28 No No Current 0280-0105-02 00280010502 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-02) 2023-12-01 No No Current 0280-0105-03 00280010503 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-03) 2024-05-07 No No Current 0280-0105-04 00280010504 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-04) 2024-05-14 No No Current 0280-0105-05 00280010505 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-05) 2024-05-21 No No Current 0280-0105-06 00280010506 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-06) 2024-06-17 No No Current