Aleve Back and Muscle Pain

Product NDC
0280-6092
11-digit product format
002806092
Labeler code
0280
Product ID
0280-6092_4526b594-84b6-b981-e063-6294a90a1aed
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
NDA020204
Marketing category
NDA
Marketing start
2018-01-26
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
Aleve Back and Muscle Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574, 849728

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
0280-6092-02Aleve Back and Muscle Pain130 in 1 BOTTLETABLET13019
0280-6092-02Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-04Aleve Back and Muscle Pain200 in 1 BOTTLETABLET20019
0280-6092-04Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-05Aleve Back and Muscle Pain225 in 1 BOTTLETABLET22519
0280-6092-05Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-06Aleve Back and Muscle Pain36 in 1 BOTTLETABLET3619
0280-6092-06Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-07Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-07Aleve Back and Muscle Pain65 in 1 BOTTLETABLET6519
0280-6092-08Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-08Aleve Back and Muscle Pain250 in 1 BOTTLETABLET25019
0280-6092-09Aleve Back and Muscle Pain90 in 1 BOTTLETABLET9019
0280-6092-09Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-10Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-10Aleve Back and Muscle Pain100 in 1 BOTTLETABLET10019
0280-6092-12Aleve Back and Muscle Pain10 in 1 VIALTABLET1019
0280-6092-24Aleve Back and Muscle Pain24 in 1 BOTTLE, PLASTICTABLET2419
0280-6092-24Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-25Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-25Aleve Back and Muscle Pain250 in 1 BOTTLETABLET25019
0280-6092-50Aleve Back and Muscle Pain1 in 1 CARTONTABLET119
0280-6092-50Aleve Back and Muscle Pain50 in 1 BOTTLE, PLASTICTABLET5019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-6092ALEVE BACK AND MUSCLE PAIN (NAPROXEN SODIUM) TABLET [BAYER HEALTHCARE LLC.]18Current NDC, Legacy NDC, 23 package rows20221007_6376e1b8-52c4-0519-e053-2a91aa0af35f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849728Aleve 220 MG Oral TabletPSN6376e1b8-52c4-0519-e053-2a91aa0af35f19
849574naproxen sodium 220 MG Oral TabletPSN6376e1b8-52c4-0519-e053-2a91aa0af35f19
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD6376e1b8-52c4-0519-e053-2a91aa0af35f19
849574naproxen sodium 220 MG Oral TabletSCD6376e1b8-52c4-0519-e053-2a91aa0af35f19
849728Aleve 220 MG Oral TabletSY6376e1b8-52c4-0519-e053-2a91aa0af35f19
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6376e1b8-52c4-0519-e053-2a91aa0af35f19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-6092-02002806092021 BOTTLE in 1 CARTON (0280-6092-02) / 130 TABLET in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
0280-6092-04002806092041 BOTTLE in 1 CARTON (0280-6092-04) / 200 TABLET in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
0280-6092-05002806092051 BOTTLE in 1 CARTON (0280-6092-05) / 225 TABLET in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
0280-6092-06002806092061 BOTTLE in 1 CARTON (0280-6092-06) > 36 TABLET in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
0280-6092-07002806092071 BOTTLE in 1 CARTON (0280-6092-07) > 65 TABLET in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
0280-6092-08002806092081 BOTTLE in 1 CARTON (0280-6092-08) / 250 TABLET in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent
0280-6092-09002806092091 BOTTLE in 1 CARTON (0280-6092-09) / 90 TABLET in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent
0280-6092-10002806092101 BOTTLE in 1 CARTON (0280-6092-10) > 100 TABLET in 1 BOTTLE1 bottle2018-01-260000-00-00NoNoCurrent
0280-6092-120028060921210 TABLET in 1 VIAL (0280-6092-12) 10 tablet2021-07-010000-00-00NoNoCurrent
0280-6092-24002806092241 BOTTLE, PLASTIC in 1 CARTON (0280-6092-24) / 24 TABLET in 1 BOTTLE, PLASTIC2018-01-260000-00-00NoNoCurrent
0280-6092-25002806092251 BOTTLE in 1 CARTON (0280-6092-25) / 250 TABLET in 1 BOTTLE1 bottle2019-08-060000-00-00NoNoCurrent
0280-6092-50002806092501 BOTTLE, PLASTIC in 1 CARTON (0280-6092-50) / 50 TABLET in 1 BOTTLE, PLASTIC2018-01-260000-00-00NoNoCurrent