FDA.reportPublic FDA data

dg health naproxen sodium

Product NDC
55910-500
11-digit product format
559100500
Labeler code
55910
Product ID
55910-500_0833bb77-1309-4ed7-ad4a-9b1044fb0799
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA074661
Marketing category
ANDA
Marketing start
2013-11-21
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

Additional Listing Data#

Finished product
Yes
Brand name base
dg health naproxen sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
55910-500-71dg health naproxen sodium50 in 1 BOTTLETABLET, FILM COATED507
55910-500-71dg health naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
55910-500-72dg health naproxen sodium60 in 1 BOTTLETABLET, FILM COATED607
55910-500-72dg health naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
55910-500-76dg health naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
55910-500-76dg health naproxen sodium120 in 1 BOTTLETABLET, FILM COATED1207
55910-500-78dg health naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
55910-500-78dg health naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1007
55910-500-82dg health naproxen sodium200 in 1 BOTTLETABLET, FILM COATED2007
55910-500-82dg health naproxen sodium1 in 1 CARTONTABLET, FILM COATED17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CDG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
NAPROXENACTIVE MOIETY57Y76R9ATQDG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-500DG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP INC]7Current NDC, Legacy NDC, 10 package rows20250119_3ca9ce63-39f4-4ba9-b464-d048fd8e67c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN3ca9ce63-39f4-4ba9-b464-d048fd8e67c07
849574naproxen sodium 220 MG Oral TabletSCD3ca9ce63-39f4-4ba9-b464-d048fd8e67c07
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY3ca9ce63-39f4-4ba9-b464-d048fd8e67c07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-500-71559100500711 BOTTLE in 1 CARTON (55910-500-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-11-210000-00-00NoNoCurrent
55910-500-72559100500721 BOTTLE in 1 CARTON (55910-500-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-11-210000-00-00NoNoCurrent
55910-500-76559100500761 BOTTLE in 1 CARTON (55910-500-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-11-210000-00-00NoNoCurrent
55910-500-78559100500781 BOTTLE in 1 CARTON (55910-500-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-11-210000-00-00NoNoCurrent
55910-500-82559100500821 BOTTLE in 1 CARTON (55910-500-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-09-050000-00-00NoNoCurrent