FDA.reportPublic FDA data

Naproxen Sodium HEADACHE PAIN

Product NDC
58602-735
11-digit product format
586020735
Labeler code
58602
Product ID
58602-735_b14dd7e8-b43c-4d9e-9609-13d9f30a74c4
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
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
58602-735-07Naproxen Sodium HEADACHE PAIN24 in 1 BOTTLETABLET, FILM COATED245
58602-735-07Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-735-19Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-735-19Naproxen Sodium HEADACHE PAIN90 in 1 BOTTLETABLET, FILM COATED905
58602-735-21Naproxen Sodium HEADACHE PAIN100 in 1 BOTTLETABLET, FILM COATED1005
58602-735-21Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-735-29Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-735-29Naproxen Sodium HEADACHE PAIN150 in 1 BOTTLETABLET, FILM COATED1505
58602-735-38Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-735-38Naproxen Sodium HEADACHE PAIN300 in 1 BOTTLETABLET, FILM COATED3005
58602-735-40Naproxen Sodium HEADACHE PAIN500 in 1 BOTTLETABLET, FILM COATED5005
58602-735-40Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15
58602-735-78Naproxen Sodium HEADACHE PAIN50 in 1 BOTTLETABLET, FILM COATED505
58602-735-78Naproxen Sodium HEADACHE PAIN1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-735NAPROXEN SODIUM HEADACHE PAIN (NAPROXEN SODIUM) TABLET, FILM COATED [AUROHEALTH LLC]5Current NDC, Legacy NDC, 14 package rows20250524_e4a9ea0e-aec4-493c-b9b4-5e5a91d260d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNe4a9ea0e-aec4-493c-b9b4-5e5a91d260d55
849574naproxen sodium 220 MG Oral TabletSCDe4a9ea0e-aec4-493c-b9b4-5e5a91d260d55
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYe4a9ea0e-aec4-493c-b9b4-5e5a91d260d55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-735-07586020735071 BOTTLE in 1 CARTON (58602-735-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-735-19586020735191 BOTTLE in 1 CARTON (58602-735-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-09-21NoNoHistorical
58602-735-21586020735211 BOTTLE in 1 CARTON (58602-735-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-735-29586020735291 BOTTLE in 1 CARTON (58602-735-29) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-735-38586020735381 BOTTLE in 1 CARTON (58602-735-38) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-735-40586020735401 BOTTLE in 1 CARTON (58602-735-40) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent
58602-735-78586020735781 BOTTLE in 1 CARTON (58602-735-78) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-140000-00-00NoNoCurrent