All Day Pain Relief

Product NDC
0363-0169
Requested package NDC
0363-0169-24
11-digit product format
003630169
Labeler code
0363
Product ID
0363-0169_44d65894-b7e5-44d2-9238-c0ce93a7f61f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA079096
Marketing category
ANDA
Marketing start
2014-03-31
Marketing end
2022-12-30
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-01690363-0169-24DDiscontinued by firm2026-08-03

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079096-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2008-12-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16cb3db0bc1861…

DailyMed Socrata Ingredients#

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 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a0c910-7dd7-6a42-e063-6394a90a491c2026-01-13WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a00020-173b-a4a1-e063-6294a90ae3992026-01-13WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANY12748345-0d79-d6f8-e063-6394a90ab6c62025-12-11WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANY1274889d-803c-d7fd-e063-6394a90ab9a82025-12-11WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMChain Drug Marketing Associationd9e72c3f-addc-4391-a7a4-2680a3e7f5c42025-12-10WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMChain Drug Marketing Association2ee83008-c012-48d6-9479-65e7d6f50f4c2025-12-10WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHarris Teeter27938b08-ff37-4587-aa81-5ec3ef21a28a2025-12-09WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
CAREALL NaproxenNAPROXEN SODIUMNew World Imports, Inc.d9a0c6e7-a70e-479a-9737-e81a2887c7782025-12-01WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
CAREALL Naproxen SodiumNAPROXEN SODIUMNew World Imports, Inc.3952324e-77f4-4117-a97a-ab56511300582025-12-01WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Medique at Home MediproxenNAPROXEN SODIUMUnifirst First Aid Corporationb591ba4f-d7d3-4c81-e053-2995a90a7c6e2025-09-09WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Medique MediproxenNAPROXEN SODIUMUnifirst First Aid Corporationf6261d45-df1f-483b-b013-3cd6f78d9d432025-09-08WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMAMERIFOODS TRADING COMPANYf6dd2150-1643-18ff-e053-6294a90a422b2025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMMarc Glassman, Inc.684e03b6-74eb-4374-a512-1c01ea216b512025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMMarc Glassman, Inc.eeda0edf-7054-42aa-af8e-4df38b918f812025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION, INC.84b9e9a4-b805-420e-83be-ebe98776d1ee2025-06-20WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
NAPROXEN SODIUMNAPROXEN SODIUMAAA Pharmaceutical, Inc.5ea3217d-845d-4781-b849-6b00babdc2142025-06-17WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMFSA STORE INC.f4326f99-142b-0b70-e053-2995a90ac9512025-06-17WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHarris Teeter38543976-ccbe-4af9-b01d-ae102452d4182025-05-21WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION, INC.04245a78-228e-439f-8ffb-9d9bc56c7bb72025-05-20WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0169-24003630169241 BOTTLE, PLASTIC in 1 BOX (0363-0169-24) > 24 TABLET in 1 BOTTLE, PLASTIC2014-03-312022-12-30NoNoCurrent