FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, 9TN87S3A3C
Rxcui1550957

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

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