FDA.reportPublic FDA data

Naproxen Sodium HEADACHE PAIN

Product NDC
58602-737
11-digit product format
586020737
Labeler code
58602
Product ID
58602-737_277b3d51-eb63-4d99-91e0-aa44d0cc8053
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA205497
Marketing category
ANDA
Marketing start
2021-07-14
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
Naproxen Sodium HEADACHE PAIN
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
58602-737-07Naproxen Sodium HEADACHE PAIN24 in 1 BOTTLETABLET, FILM COATED245
58602-737-07Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-12Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-12Naproxen Sodium HEADACHE PAIN40 in 1 BOTTLETABLET, FILM COATED405
58602-737-19Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-19Naproxen Sodium HEADACHE PAIN90 in 1 BOTTLETABLET, FILM COATED905
58602-737-21Naproxen Sodium HEADACHE PAIN100 in 1 BOTTLETABLET, FILM COATED1005
58602-737-21Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-25Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-25Naproxen Sodium HEADACHE PAIN130 in 1 BOTTLETABLET, FILM COATED1305
58602-737-29Naproxen Sodium HEADACHE PAIN150 in 1 BOTTLETABLET, FILM COATED1505
58602-737-29Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-34Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-34Naproxen Sodium HEADACHE PAIN200 in 1 BOTTLETABLET, FILM COATED2005
58602-737-38Naproxen Sodium HEADACHE PAIN300 in 1 BOTTLETABLET, FILM COATED3005
58602-737-38Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-40Naproxen Sodium HEADACHE PAIN500 in 1 BOTTLETABLET, FILM COATED5005
58602-737-40Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-44Naproxen Sodium HEADACHE PAIN400 in 1 BOTTLETABLET, FILM COATED4005
58602-737-78Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-737-78Naproxen Sodium HEADACHE PAIN50 in 1 BOTTLETABLET, FILM COATED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-737NAPROXEN SODIUM HEADACHE PAIN (NAPROXEN SODIUM) TABLET, FILM COATED [AUROHEALTH LLC]5Current NDC, Legacy NDC, 21 package rows20250528_10464576-0f9a-4a64-a388-3afe33682938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN10464576-0f9a-4a64-a388-3afe336829385
849574naproxen sodium 220 MG Oral TabletSCD10464576-0f9a-4a64-a388-3afe336829385
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY10464576-0f9a-4a64-a388-3afe336829385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-737-07586020737071 BOTTLE in 1 CARTON (58602-737-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-12586020737121 BOTTLE in 1 CARTON (58602-737-12) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-19586020737191 BOTTLE in 1 CARTON (58602-737-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-02NoNoHistorical
58602-737-21586020737211 BOTTLE in 1 CARTON (58602-737-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-25586020737251 BOTTLE in 1 CARTON (58602-737-25) / 130 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-29586020737291 BOTTLE in 1 CARTON (58602-737-29) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-34586020737341 BOTTLE in 1 CARTON (58602-737-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-38586020737381 BOTTLE in 1 CARTON (58602-737-38) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-40586020737401 BOTTLE in 1 CARTON (58602-737-40) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-737-4458602073744400 TABLET, FILM COATED in 1 BOTTLE (58602-737-44) 2021-07-140000-00-00NoNoCurrent
58602-737-78586020737781 BOTTLE in 1 CARTON (58602-737-78) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent