Home NDC 69168-362 Naproxen Caplets
Product NDC 69168-362
11-digit product format 691680362
Labeler code 69168
Product ID 69168-362_18185cb8-53e0-4d19-ba7f-46d57e6f911a
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium 220 mg
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application ANDA090545
Marketing category ANDA
Marketing start 2014-12-23
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69168-362-50 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69168-362-50 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69168-362-50 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69168-362-50 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69168-362-50 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69168-362-50 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69168-362-50 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69168-362-50 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69168-362-50 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69168-362-50 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69168-362-50 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69168-362-50 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 A090545-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16
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 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Naproxen Caplets
Brand name suffix All day relief for 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849574 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 69168-362-07 Naproxen CapletsAll day relief for pain 1 in 1 CARTON TABLET 1 6 69168-362-07 Naproxen CapletsAll day relief for pain 10 in 1 BOTTLE TABLET 10 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-362 NAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH] 6 Current NDC, Legacy NDC, 2 package rows 20210422_81ab5ec4-23c5-44da-b6c8-62f3d3077d48.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 · 22 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 69168-362-07 69168036207 1 BOTTLE in 1 CARTON (69168-362-07) / 10 TABLET in 1 BOTTLE 1 bottle 2014-12-23 0000-00-00 No No Current 69168-362-50 69168036250 1 BOTTLE in 1 CARTON (69168-362-50) > 50 TABLET in 1 BOTTLE 1 bottle 2014-12-23 0000-00-00 No No Current