FDA.reportPublic FDA data

Aleve liquid gels

Product NDC
0280-0105
11-digit product format
002800105
Labeler code
0280
Product ID
0280-0105_2766b060-5c1b-41fb-b8ca-cfb1a021b64e
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer Healthcare LLC
Application
ANDA214463
Marketing category
ANDA
Marketing start
2023-12-01
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
Aleve liquid gels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1112231, 1112233

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
0280-0105-01Aleve liquid gels120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1202
0280-0105-02Aleve liquid gels160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1602
0280-0105-03Aleve liquid gels20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED202
0280-0105-04Aleve liquid gels50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED502
0280-0105-05Aleve liquid gels80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED802
0280-0105-06Aleve liquid gels80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0105ALEVE LIQUID GELS (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC]2Current NDC, 6 package rows20240510_a0587c73-d297-462d-a0ef-750cb324486e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112233Aleve 220 MG Oral CapsulePSNa0587c73-d297-462d-a0ef-750cb324486e2
1112231naproxen sodium 220 MG Oral CapsulePSNa0587c73-d297-462d-a0ef-750cb324486e2
1112233naproxen sodium 220 MG Oral Capsule [Aleve]SBDa0587c73-d297-462d-a0ef-750cb324486e2
1112231naproxen sodium 220 MG Oral CapsuleSCDa0587c73-d297-462d-a0ef-750cb324486e2
1112233Aleve 220 MG (naproxen 200 MG) Oral CapsuleSYa0587c73-d297-462d-a0ef-750cb324486e2
1112233Aleve 220 MG Oral CapsuleSYa0587c73-d297-462d-a0ef-750cb324486e2
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSYa0587c73-d297-462d-a0ef-750cb324486e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0280-0105-0100280010501120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-01) 2024-06-28NoNoCurrent
0280-0105-0200280010502160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-02) 2023-12-01NoNoCurrent
0280-0105-030028001050320 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-03) 2024-05-07NoNoCurrent
0280-0105-040028001050450 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-04) 2024-05-14NoNoCurrent
0280-0105-050028001050580 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-05) 2024-05-21NoNoCurrent
0280-0105-060028001050680 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-06) 2024-06-17NoNoCurrent