good sense naproxen sodium

Product NDC
0113-8264
11-digit product format
001138264
Labeler code
0113
Product ID
0113-8264_2d70302c-e43d-4422-a002-57505904f605
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride, naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA208499
Marketing category
ANDA
Marketing start
2018-12-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength
25; 220 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-82640113-8264-58DDiscontinued 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
A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2019-05-10

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 UTC2026-02A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103f01610625f2…
2019-09-15 20:21 UTC2019-09A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208499-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2019-05-10cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
good sense naproxen sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
NAPROXEN SODIUM220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
9TN87S3A3CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1550957Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f548aa3d-b35e-458a-9815-3595a451ab78Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-8264-00good sense naproxen sodium160 in 1 BOTTLETABLET, FILM COATED1607
0113-8264-06good sense naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
0113-8264-58good sense naproxen sodium40 in 1 BOTTLETABLET, FILM COATED407
0113-8264-58good sense naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
0113-8264-60good sense naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
0113-8264-60good sense naproxen sodium20 in 1 BOTTLETABLET, FILM COATED207
0113-8264-71good sense naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
0113-8264-71good sense naproxen sodium50 in 1 BOTTLETABLET, FILM COATED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-8264-58EA - Each0113-8264cc3fc1b7-de81-431d-a863-f08e085806fd12022-05-04
0113-8264-60EA - Each0113-8264e8ee7044-c69a-4bec-b685-bf4f779f4ccc12022-05-04
0113-8264-71EA - Each0113-8264a1a7bc1b-803a-444d-9ebc-4ff9d33602b812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-8264GOOD SENSE NAPROXEN SODIUM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 8 package rows20230812_f548aa3d-b35e-458a-9815-3595a451ab78.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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMMeijer Distribution Inc34d635f8-9703-4c29-92a5-85d3b47c4c932026-07-07WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
good sense naproxen sodiumDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUML. Perrigo Companyf548aa3d-b35e-458a-9815-3595a451ab782026-05-11WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
ndc (product): 0113-8264
ALL NIGHT PAIN RELIEF PMDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMWalgreen Company43e4ed28-b1be-4548-86ac-f40f9f83f04e2026-04-27WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMH E B4281faf5-7182-404f-9f53-3d9ea0354a182026-02-12WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
topcare all night pain relief pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMTopco Associates LLCa20f193e-4e64-400a-b605-df08026cb80b2025-12-11WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
up and up naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMTarget Corporationc0769941-bcf2-4237-b70c-a79089ad53352025-11-05WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
dg health naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMDolgencorp Inc6c2c087c-e36d-4971-b977-d3cab6d6edee2025-11-05WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMKroger Companyd5dafdd0-968d-4ee6-9461-1f72d32552402025-07-10WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
NAPROXEN SODIUM PMDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMSafeway60cb7b6e-f2d2-48ca-8db7-7124717735d52025-07-09WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
equaline naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFIed7bfa3f-4972-4ab6-9f0c-0873a11571a92025-06-04WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
basic care naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMAmazon.com Services LLC7beed9e7-816b-494b-93fa-9caf10aa38342024-01-24WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499
careone naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMAmerican Sales Company16547905-59c0-4936-82e1-2d9f5935d8dd2023-12-11WarningsExact identifier
application applno (ANDA): 208499
application number: ANDA208499

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSNf548aa3d-b35e-458a-9815-3595a451ab787
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCDf548aa3d-b35e-458a-9815-3595a451ab787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-8264-0000113826400160 in 1 BOTTLEHistorical
0113-8264-06001138264061 BOTTLE in 1 CARTON (0113-8264-06) / 160 TABLET, FILM COATED in 1 BOTTLE (0113-8264-00) 1 bottle2026-02-26NoNoCurrent
0113-8264-58001138264581 BOTTLE in 1 CARTON (0113-8264-58) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-06-060000-00-00NoNoCurrent
0113-8264-60001138264601 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-280000-00-00NoNoCurrent
0113-8264-71001138264711 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-03-140000-00-00NoNoCurrent