NAPROXEN SODIUM

Product NDC
67060-000
11-digit product format
670600000
Labeler code
67060
Product ID
67060-000_9e1ecaa5-f25b-497f-a68a-99432beacc7c
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
ADVANCED FIRST AID, INC.
Application
ANDA090545
Marketing category
ANDA
Marketing start
2015-04-09
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
200 1/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67060-000IInactivated by FDA2026-08-07
excluded packagepackage67060-00067060-000-68IInactivated by FDA2026-08-07

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 · 30 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 packagepackage67060-000-68d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67060-000-68f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67060-000-682ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67060-000-68a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67060-000-68cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67060-000-68cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67060-000-68302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67060-000-68ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67060-000-680efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67060-000-68ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67060-000-68367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67060-000-68557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67060-000-688af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67060-000-68834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67060-000-681332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67060-000-682023-01-30C16284748780-1f386c64a-4582-0266-e053-dadaa90a7c1a344f908c-934e-4c98-aeef-68fd09d47c72

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67060-000-68NAPROXEN SODIUM1 in 1 PACKETTABLET11
67060-000-68NAPROXEN SODIUM50 in 1 CARTONTABLET501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67060-000NAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]1Legacy NDC, 2 package rows20150410_344f908c-934e-4c98-aeef-68fd09d47c72.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
1608797naproxen sodium 200 MG Oral TabletPSN344f908c-934e-4c98-aeef-68fd09d47c721
1608797naproxen 200 MG Oral TabletSCD344f908c-934e-4c98-aeef-68fd09d47c721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67060-000-686706000006850 PACKET in 1 CARTON (67060-000-68) > 1 TABLET in 1 PACKET50 packet2015-04-090000-00-00NoNoCurrent