Naproxen Sodium

Product NDC
37012-748
11-digit product format
370120748
Labeler code
37012
Product ID
37012-748_55324160-1aea-4366-805f-e6094bc5a891
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC.
Application
ANDA208363
Marketing category
ANDA
Marketing start
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37012-748DDiscontinued by firm2026-08-03
excluded packagepackage37012-74837012-748-40DDiscontinued 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 · 24 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 packagepackage37012-748-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-748-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-748-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-748-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-748-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-748-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-748-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-748-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-748-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-748-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-748-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-748-40557ba5c1ecfa…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
A208363-001NAPROXEN SODIUMNAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15

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 UTC2026-02A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-11-17Drug Facts
2020-09-27Drug Facts
2020-09-25Drug Facts
2020-07-22Drug Facts

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)c28c4fd2-1428-421c-b62f-265e472d833e2026-07-09WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMCVS Pharmacyc194124b-a5f6-423e-bc9a-7b611df990a82026-05-13WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMWalgreensd9806ad8-1cea-4599-97ef-a956ec7f0e212026-03-11WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMSafeway, Inc.deb1be0f-64ae-46b5-b54a-1a58eec6492e2026-01-05WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMP & L Development, LLCfc65fe79-c93b-4247-b9af-e562792a3e642025-08-19WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMAAFES/Your Military Exchangesc387f7cb-7cc4-4989-9f9a-bb00a895fd0d2025-05-08WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMProductos Zapotol Corp.6386f6f6-9bc7-4b85-ac87-03fd147259042024-03-14WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMProductos Zapotol Corp.0a69f39e-5eb6-4a98-85f0-87e7449672d62024-03-14WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMCare One (Retail Business Services, LLC.)5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad2024-02-21WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
All Day ReliefNAPROXEN SODIUMPublix Supermarkets, Inc.4db86c5b-62bb-4638-9f1e-98dc2680d6cc2024-01-23WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMTARGET Corporation36ce5cd9-8c61-4ed9-b840-c29ad98bdfc52023-10-25WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMStrategic Sourcing Services LLC435e55b2-3d75-4a1e-9f00-69b29baf37af2023-10-02WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMCare One (American Sales Company)043f7032-4e83-4642-93a8-6c09de26b43f2022-11-21WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMStrategic Sourcing Services LLCa636037d-127c-478d-9d61-dda6eafd2e812022-11-15WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
Naproxen SodiumNAPROXEN SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de03311d-fb58-43f5-a110-aac9a39c91322022-11-07WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
NAPROXEN SODIUMNAPROXEN SODIUMPuraCap Pharmaceutical LLCfc865e81-164c-48e9-8fb9-6fc27d1c33cf2019-12-10WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363
NAPROXEN SODIUMNAPROXEN SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd1d5981dd-e3f5-48a3-a5f1-ce49689cdfac2019-11-08WarningsExact identifier
application applno (ANDA): 208363
application number: ANDA208363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37012-748-40370120748401 BOTTLE, PLASTIC in 1 BOX (37012-748-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-12-312022-12-30NoNoCurrent