FDA.reportPublic FDA data

Flanax Pain Reliever/Fever reducer

Product NDC
27854-505
11-digit product format
278540505
Labeler code
27854
Product ID
27854-505_937b99a5-63ed-4f0d-8866-69c60d9743d8
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Belmora LLC
Application
ANDA090545
Marketing category
ANDA
Marketing start
2020-05-15
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
Flanax Pain Reliever/Fever reducer
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
27854-505-01Flanax Pain Reliever/Fever reducer24 in 1 BOTTLETABLET, COATED242
27854-505-01Flanax Pain Reliever/Fever reducer1 in 1 CARTONTABLET, COATED12
27854-505-02Flanax Pain Reliever/Fever reducer1 in 1 CARTONTABLET, COATED12
27854-505-02Flanax Pain Reliever/Fever reducer2 in 1 BOTTLETABLET, COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-505FLANAX PAIN RELIEVER/FEVER REDUCER (NAPROXEN SODIUM) TABLET, COATED [BELMORA LLC]2Current NDC, Legacy NDC, 4 package rows20200531_05337e0b-8baf-42d6-a642-3052f77ed304.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN05337e0b-8baf-42d6-a642-3052f77ed3042
849574naproxen sodium 220 MG Oral TabletSCD05337e0b-8baf-42d6-a642-3052f77ed3042
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY05337e0b-8baf-42d6-a642-3052f77ed3042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27854-505-01278540505011 BOTTLE in 1 CARTON (27854-505-01) / 24 TABLET, COATED in 1 BOTTLE1 bottle2020-05-150000-00-00NoNoCurrent
27854-505-02278540505021 BOTTLE in 1 CARTON (27854-505-02) / 2 TABLET, COATED in 1 BOTTLE1 bottle2020-05-150000-00-00NoNoCurrent