All Day Pain Relief

Product NDC
55319-417
11-digit product format
553190417
Labeler code
55319
Product ID
55319-417_70633ba7-5467-46eb-8ef0-eeb2060cfb95
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Family Dollar Services Inc
Application
ANDA204872
Marketing category
ANDA
Marketing start
2017-01-23
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-417DDiscontinued by firm2026-08-17
excluded packagepackage55319-41755319-417-12DDiscontinued by firm2026-08-17
excluded packagepackage55319-41755319-417-62DDiscontinued by firm2026-08-17

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-417-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-417-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-417-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-417-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-417-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-417-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-417-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-417-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-417-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-417-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-417-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-417-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-417-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-417-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-417-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-417-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-417-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-417-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-417-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-417-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-417-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-417-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-417-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-417-62557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204872-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2017-01-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233f01610625f2…
2019-09-15 20:21 UTC2019-09A204872-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2017-01-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A204872-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2017-01-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23e64feba35796…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArtridolNAPROXEN SODIUMZapotol Products Corpc422d300-3f4e-4121-8eaf-56683911b8842026-08-05WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMPreferred Pharmaceuticals, Inc.20eb9d9f-11df-464f-a1b0-949f8fda40422026-07-28WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Back and Muscle PainNAPROXEN SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4039504c-e612-4503-854a-62ee067809562026-07-13WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMLidl US LLC3d01220c-c5ec-4604-8cef-9ecb807ccd532026-06-22WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporation134e5ec6-c42a-43b6-adf2-2d7546875ead2026-06-19WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen Headache PainNAPROXEN SODIUML.N.K. International, Inc.6161b881-f422-47ae-86ba-a28d669bce792026-06-18WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMFamily Dollar Services Incd9c63e1f-c2ad-434b-8a21-7fff21b7477b2026-06-03WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporatione6277515-c606-4535-9c29-08cade045aee2026-05-14WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen Back and Muscle PainNAPROXEN SODIUML.N.K. International, Inc.68944663-0dc0-4d3a-a36b-019061bdbfa02026-03-09WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
AnaDentNAPROXEN SODIUMBelmora LLC236674db-da4d-415c-a160-7086eaf5bff52026-03-03WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUML.N.K. International, Inc.717518e4-2537-4229-b765-c6acfe963d4b2026-02-25WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMBetter Living Brands, LLC3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c0412026-02-13WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Back and Muscle PainNAPROXEN SODIUMRite Aid Corporatione162bd50-f94a-4c76-8f1b-62114f2838092026-02-11WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Flanax Menstrual Pain RelieverNAPROXEN SODIUMBelmora LLC2b4135b3-389c-46e2-ae86-7674c2ab9a322026-01-27WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
FlanaxNAPROXEN SODIUMBelmora LLC2c099d45-f03a-4161-a6af-8fe5965f27482026-01-06WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
All Day Pain ReliefNAPROXEN SODIUMWALMART INC.c4909e43-57ba-44bc-a234-a02cc884891c2025-12-11WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
24/7 Life by 7-Eleven Naproxen SodiumNAPROXEN SODIUM TABLET, FILM COATEDLil' Drug Store Products, Inc.44716954-006a-4c56-e063-6294a90a0f142025-11-25WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMAthlete's Needs Incd5984c9d-3941-45d6-8392-87564b2faae02025-11-15WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMBetter Living Brands, LLC43745d42-f859-4168-a2dd-2c8ae47ae5902025-10-28WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMFamily Dollar Services Incb6205032-f5c6-494a-8b87-adbbbc3982e72025-10-27WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-417-12553190417121 BOTTLE, PLASTIC in 1 CARTON (55319-417-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2017-01-230000-00-00NoNoCurrent
55319-417-62553190417621 BOTTLE in 1 CARTON (55319-417-62) > 15 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-01-230000-00-00NoNoCurrent