FDA.reportPublic FDA data

DG Health Naproxen Sodium

Product NDC
55910-481
11-digit product format
559100481
Labeler code
55910
Product ID
55910-481_249633f2-c546-408c-a8aa-c1ada9b55a56
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
2021-05-26
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
55910-481-62DG Health Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED12
55910-481-62DG Health Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED242
55910-481-71DG Health Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED502
55910-481-71DG Health Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-481DG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP INC]2Current NDC, Legacy NDC, 4 package rows20250109_43926764-f8d1-42b4-b55b-0524d9ff98f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN43926764-f8d1-42b4-b55b-0524d9ff98f32
849574naproxen sodium 220 MG Oral TabletSCD43926764-f8d1-42b4-b55b-0524d9ff98f32
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY43926764-f8d1-42b4-b55b-0524d9ff98f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-481-62559100481621 BOTTLE in 1 CARTON (55910-481-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-260000-00-00NoNoCurrent
55910-481-71559100481711 BOTTLE in 1 CARTON (55910-481-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-260000-00-00NoNoCurrent