FDA.reportPublic FDA data

DG Health Naproxen Sodium

Product NDC
55910-490
11-digit product format
559100490
Labeler code
55910
Product ID
55910-490_bec55e78-f320-46a3-88b9-87d61b0c7f7c
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
2016-04-25
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
55910-490-62DG Health Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED16
55910-490-62DG Health Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED246
55910-490-71DG Health Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED506
55910-490-71DG Health Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED16
55910-490-78DG Health Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1006
55910-490-78DG Health Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-490DG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP INC]6Current NDC, Legacy NDC, 6 package rows20250209_534eaf8a-0d2a-4390-af92-af5c98ba56a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN534eaf8a-0d2a-4390-af92-af5c98ba56a56
849574naproxen sodium 220 MG Oral TabletSCD534eaf8a-0d2a-4390-af92-af5c98ba56a56
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY534eaf8a-0d2a-4390-af92-af5c98ba56a56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-490-62559100490621 BOTTLE in 1 CARTON (55910-490-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-250000-00-00NoNoCurrent
55910-490-71559100490711 BOTTLE in 1 CARTON (55910-490-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-250000-00-00NoNoCurrent
55910-490-78559100490781 BOTTLE in 1 CARTON (55910-490-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-180000-00-00NoNoCurrent