Naproxen Caplets

Product NDC
69168-362
11-digit product format
691680362
Labeler code
69168
Product ID
69168-362_18185cb8-53e0-4d19-ba7f-46d57e6f911a
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium 220 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA090545
Marketing category
ANDA
Marketing start
2014-12-23
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

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 productproduct69168-362DDiscontinued by firm2026-08-07
excluded packagepackage69168-36269168-362-50DDiscontinued by firm2026-08-07

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 packagepackage69168-362-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69168-362-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69168-362-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69168-362-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69168-362-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69168-362-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69168-362-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69168-362-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69168-362-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69168-362-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69168-362-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69168-362-50557ba5c1ecfa…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
A090545-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-03-16

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 UTC2026-02A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163f01610625f2…
2019-09-15 20:21 UTC2019-09A090545-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-03-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A090545-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-03-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Caplets
Brand name suffix
All day relief for pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9TN87S3A3CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849574Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81ab5ec4-23c5-44da-b6c8-62f3d3077d48Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-362-07Naproxen CapletsAll day relief for pain1 in 1 CARTONTABLET16
69168-362-07Naproxen CapletsAll day relief for pain10 in 1 BOTTLETABLET106

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-362NAPROXEN CAPLETS ALL DAY RELIEF FOR PAIN (NAPROXEN SODIUM 220 MG) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 2 package rows20210422_81ab5ec4-23c5-44da-b6c8-62f3d3077d48.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium 220mgNAPROXEN SODIUM 220MGGrocery Outlet1f5b5c55-44df-4872-8c74-b8a812efc32a2026-03-18WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
BACK AND MUSCLE PAINNAPROXENWALGREENS81417810-8a34-c859-e053-2a91aa0a65072026-01-26WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
CALMADOL PAIN RELIEVERNAPROXEN SODIUMGRANDALL DISTRIBUTING, LLC8edec8d1-a323-436b-8329-c327438516e32025-10-28WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Naproxen SodiumNAPROXEN SODIUM 220MGCVS Pharmacy, Inc.1fde52e7-7a7f-40e8-e063-6394a90a922a2025-08-11WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
All Day Pain ReliefNAPROXEN SODIUMWalmart Inc.32df7378-4dd1-4f7e-e063-6394a90ad9482025-05-09WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Belmora FlanaxNAPROXEN SODIUMBelmora LLCa44b8a82-251d-d5e8-e053-2a95a90a72f72024-10-08WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENS8771b84f-47bf-116c-e053-2995a90a0aad2024-03-15WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENS8771300f-e907-3d53-e053-2a95a90ae4022024-03-15WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
All Day Back and Muscle Pain ReliefNAPROXEN SODIUMWalmart Inc.062b9ffe-b4fc-9f5a-e063-6294a90a560e2023-12-04WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INCab7b7b8e-923b-4dc1-812c-78e85de1bee12023-09-13WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Pain ReliefNAPROXEN SODIUMBETTER LIVING BRANDS, LLCeb604ea6-f5c1-156b-e053-2a95a90a76d72023-06-13WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Naproxen SodiumNAPROXEN SODIUMBETTER LIVING BRANDS LLC.f2c06861-0322-93ed-e053-2995a90a59022023-06-13WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Naproxen SodiumNAPROXEN SODIUM, COATED TABLETSMARKSANS PHARMA LIMITED48cb1363-ff12-40ee-a87a-2252dfbf8ff72023-06-09WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Flanax Pain Reliever/Fever ReducerNAPROXEN SODIUMNavajo Manufacturing Company Inc.f706b406-58f2-9b82-e053-6394a90ab5982023-03-16WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INC17ecaee0-c1c6-4360-81c1-d6afe50b9b272021-12-01WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
NAPROXEN SODIUMNAPROXEN SODIUMKroger Companybc185bf2-bc2c-f439-e053-2995a90a93d02021-06-03WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Naproxen Sodium 220mgNAPROXEN SODIUM 220MGAllegiant Health14554f05-14e1-4c52-99ce-94561c42c0da2021-04-21WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Flanax Pain Reliever/Fever reducerNAPROXEN SODIUMBelmora LLC05337e0b-8baf-42d6-a642-3052f77ed3042020-05-29WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Naproxen CapletsNAPROXEN SODIUM 220 MGAllegiant Health07120764-7c33-4c07-9367-40956d970c602019-06-06WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545
Naproxen Sodium 220mgNAPROXEN SODIUM 220MGCommand Brands, LLC002052df-83ac-4efd-926c-b60a8f64cec42018-12-14WarningsExact identifier
application applno (ANDA): 090545
application number: ANDA090545

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN81ab5ec4-23c5-44da-b6c8-62f3d3077d486
849574naproxen sodium 220 MG Oral TabletSCD81ab5ec4-23c5-44da-b6c8-62f3d3077d486
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY81ab5ec4-23c5-44da-b6c8-62f3d3077d486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-362-07691680362071 BOTTLE in 1 CARTON (69168-362-07) / 10 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent
69168-362-50691680362501 BOTTLE in 1 CARTON (69168-362-50) > 50 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent