FDA.reportPublic FDA data

Aleve Back and Muscle Pain

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
full-release
Hydrated at
2026-06-01 01:19:52

Label at a glance#

ProductAleve Back and Muscle Pain
Active ingredientNAPROXEN SODIUM
Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg)

(NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches
    • minor pain of arthritis
    • menstrual cramps
    • headache
    • toothache
    • the common cold
  • temporarily reduces fever

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
Adults and children 12 years and older
  • take 1 tablets every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8-to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
Children under 12 years
  • ask a doctor

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: sodium 20 mg
  • store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

SPL UNCLASSIFIED SECTION

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Package label display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aleve Back and Muscle Pain - 24 Count CartonAleve Back and Muscle Pain - 24 Count CartonAll Day Strong®

Aleve®

Back & Muscle Pain

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of minor back and muschle aches and pains

ACTUAL SIZE

Strength to Last 12 Hours 24Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849728Aleve 220 MG Oral TabletPSN19
849574naproxen sodium 220 MG Oral TabletPSN19
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD19
849574naproxen sodium 220 MG Oral TabletSCD19
849728Aleve 220 MG Oral TabletSY19
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY19

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130025866592001GTIN-13: 0025866592001
EAN-13: 0025866592001
GTIN-12: 025866592001
UPC-A: 025866592001
GTIN storage (14 digits): 00025866592001		Aleve Back and Muscle Pain - 24 Count Carton.jpg

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-60920280-6092-24, 0280-6092-50, 0280-6092-10, 0280-6092-25, 0280-6092-02, 0280-6092-04, 0280-6092-05, 0280-6092-06, 0280-6092-07, 0280-6092-08, 0280-6092-09, 0280-6092-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POVIDONEFZ989GH94EIACT
NAPROXEN SODIUM9TN87S3A3CACTIB
FD&C BLUE NO. 2L06K8R7DQKIACT
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020204-002ALEVENAPROXEN SODIUM220MGTABLET / ORALRLD, RS1994-01-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1184e616aacf4f…
2026-08-18 06:07:402026-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020204-002ALEVEEQ 200MG BASETABLET / ORALRLD, RS1994-01-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020204-002ALEVEEQ 200MG BASETABLET / ORALRLD, RS1994-01-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve Back and Muscle PainNAPROXEN SODIUMBayer HealthCare LLC.6376e1b8-52c4-0519-e053-2a91aa0af35f2025-12-04Exact identifier
ndc (package): 0280-6092-08
ndc (package): 0280-6092-24
ndc (package): 0280-6092-05
ndc (package): 0280-6092-50
ndc (package): 0280-6092-04
ndc (package): 0280-6092-07
ndc (package): 0280-6092-09
ndc (package): 0280-6092-06
ndc (package): 0280-6092-12
ndc (package): 0280-6092-10
ndc (package): 0280-6092-02
ndc (package): 0280-6092-25
ndc (product): 0280-6092
ndc11 (package): 00280609210
ndc11 (package): 00280609212
ndc11 (package): 00280609224
ndc11 (package): 00280609208
ndc11 (package): 00280609207
ndc11 (package): 00280609225
ndc11 (package): 00280609202
ndc11 (package): 00280609204
ndc11 (package): 00280609250
ndc11 (package): 00280609205
ndc11 (package): 00280609209
ndc11 (package): 00280609206
spl id: 4526b594-84b6-b981-e063-6294a90a1aed
spl set id: 6376e1b8-52c4-0519-e053-2a91aa0af35f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.