Home NDC 58602-739 Naproxen Sodium BACK AND MUSCLE PAIN
Product NDC 58602-739
11-digit product format 586020739
Labeler code 58602
Product ID 58602-739_ff1010cd-0fc3-4e54-8a03-f3dfa1417926
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurohealth LLC
Application ANDA205497
Marketing category ANDA
Marketing start 2021-07-14
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 A205497-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18
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 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205497-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2016-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205497-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2016-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205497-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2016-03-18 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Naproxen Sodium 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 · 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 58602-739-07 Naproxen Sodium BACK AND MUSCLE PAIN 24 in 1 BOTTLE TABLET, FILM COATED 24 5 58602-739-07 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-12 Naproxen Sodium BACK AND MUSCLE PAIN 40 in 1 BOTTLE TABLET, FILM COATED 40 5 58602-739-12 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-19 Naproxen Sodium BACK AND MUSCLE PAIN 90 in 1 BOTTLE TABLET, FILM COATED 90 5 58602-739-19 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-21 Naproxen Sodium BACK AND MUSCLE PAIN 100 in 1 BOTTLE TABLET, FILM COATED 100 5 58602-739-21 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-25 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-25 Naproxen Sodium BACK AND MUSCLE PAIN 130 in 1 BOTTLE TABLET, FILM COATED 130 5 58602-739-29 Naproxen Sodium BACK AND MUSCLE PAIN 150 in 1 BOTTLE TABLET, FILM COATED 150 5 58602-739-29 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-34 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-34 Naproxen Sodium BACK AND MUSCLE PAIN 200 in 1 BOTTLE TABLET, FILM COATED 200 5 58602-739-38 Naproxen Sodium BACK AND MUSCLE PAIN 300 in 1 BOTTLE TABLET, FILM COATED 300 5 58602-739-38 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-40 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-40 Naproxen Sodium BACK AND MUSCLE PAIN 500 in 1 BOTTLE TABLET, FILM COATED 500 5 58602-739-44 Naproxen Sodium BACK AND MUSCLE PAIN 400 in 1 BOTTLE TABLET, FILM COATED 400 5 58602-739-78 Naproxen Sodium BACK AND MUSCLE PAIN 1 in 1 CARTON TABLET, FILM COATED 1 5 58602-739-78 Naproxen Sodium BACK AND MUSCLE PAIN 50 in 1 BOTTLE TABLET, FILM COATED 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-739 NAPROXEN SODIUM BACK AND MUSCLE PAIN (NAPROXEN SODIUM) TABLET, FILM COATED [AUROHEALTH LLC] 5 Current NDC, Legacy NDC, 21 package rows 20250528_666e3c6a-e571-4124-84d8-0142db1012dc.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 · 12 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 58602-739-07 58602073907 1 BOTTLE in 1 CARTON (58602-739-07) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-12 58602073912 1 BOTTLE in 1 CARTON (58602-739-12) / 40 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-19 58602073919 1 BOTTLE in 1 CARTON (58602-739-19) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-08-02 No No Current 58602-739-21 58602073921 1 BOTTLE in 1 CARTON (58602-739-21) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-25 58602073925 1 BOTTLE in 1 CARTON (58602-739-25) / 130 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-29 58602073929 1 BOTTLE in 1 CARTON (58602-739-29) / 150 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-34 58602073934 1 BOTTLE in 1 CARTON (58602-739-34) / 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-38 58602073938 1 BOTTLE in 1 CARTON (58602-739-38) / 300 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-40 58602073940 1 BOTTLE in 1 CARTON (58602-739-40) / 500 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current 58602-739-44 58602073944 400 TABLET, FILM COATED in 1 BOTTLE (58602-739-44) 2021-07-14 0000-00-00 No No Current 58602-739-78 58602073978 1 BOTTLE in 1 CARTON (58602-739-78) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-07-14 0000-00-00 No No Current