Home NDC 51316-417-08 Naproxen Sodium
Product NDC 51316-417
Requested package NDC 51316-417-08
11-digit product format 513160417
Labeler code 51316
Product ID 51316-417_01b06900-15bc-4867-a347-d5f0101d4fb8
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application ANDA204872
Marketing category ANDA
Marketing start 2021-11-04
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 42 .
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 A204872-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23
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 · 42 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 2026-08-18 06:07:40 2026-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204872-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2017-01-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204872-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2017-01-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 e64feba35796…
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 · 28 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Artridol NAPROXEN SODIUM Zapotol Products Corp c422d300-3f4e-4121-8eaf-56683911b884 2026-08-05 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Preferred Pharmaceuticals, Inc. 20eb9d9f-11df-464f-a1b0-949f8fda4042 2026-07-28 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Back and Muscle Pain NAPROXEN SODIUM CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 4039504c-e612-4503-854a-62ee06780956 2026-07-13 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Lidl US LLC 3d01220c-c5ec-4604-8cef-9ecb807ccd53 2026-06-22 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Rite Aid Corporation 134e5ec6-c42a-43b6-adf2-2d7546875ead 2026-06-19 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Headache Pain NAPROXEN SODIUM L.N.K. International, Inc. 6161b881-f422-47ae-86ba-a28d669bce79 2026-06-18 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Family Dollar Services Inc d9c63e1f-c2ad-434b-8a21-7fff21b7477b 2026-06-03 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Rite Aid Corporation e6277515-c606-4535-9c29-08cade045aee 2026-05-14 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Back and Muscle Pain NAPROXEN SODIUM L.N.K. International, Inc. 68944663-0dc0-4d3a-a36b-019061bdbfa0 2026-03-09 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 AnaDent NAPROXEN SODIUM Belmora LLC 236674db-da4d-415c-a160-7086eaf5bff5 2026-03-03 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM L.N.K. International, Inc. 717518e4-2537-4229-b765-c6acfe963d4b 2026-02-25 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Better Living Brands, LLC 3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041 2026-02-13 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Back and Muscle Pain NAPROXEN SODIUM Rite Aid Corporation e162bd50-f94a-4c76-8f1b-62114f283809 2026-02-11 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Flanax Menstrual Pain Reliever NAPROXEN SODIUM Belmora LLC 2b4135b3-389c-46e2-ae86-7674c2ab9a32 2026-01-27 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Flanax NAPROXEN SODIUM Belmora LLC 2c099d45-f03a-4161-a6af-8fe5965f2748 2026-01-06 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 All Day Pain Relief NAPROXEN SODIUM WALMART INC. c4909e43-57ba-44bc-a234-a02cc884891c 2025-12-11 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 24/7 Life by 7-Eleven Naproxen Sodium NAPROXEN SODIUM TABLET, FILM COATED Lil' Drug Store Products, Inc. 44716954-006a-4c56-e063-6294a90a0f14 2025-11-25 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen Sodium NAPROXEN SODIUM Athlete's Needs Inc d5984c9d-3941-45d6-8392-87564b2faae0 2025-11-15 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Better Living Brands, LLC 43745d42-f859-4168-a2dd-2c8ae47ae590 2025-10-28 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872 Naproxen NAPROXEN SODIUM Family Dollar Services Inc b6205032-f5c6-494a-8b87-adbbbc3982e7 2025-10-27 Warnings Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51316-417-08 51316041708 1 BOTTLE, PLASTIC in 1 CARTON (51316-417-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2021-11-04 0000-00-00 No No Current