Indications and uses
temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold temporarily reduces fever
temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold temporarily reduces fever
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 tablet 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
Naproxen Sodium 220mg
Pain reliever/fever reducer
Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| Adults and children 12 years and older |
|
| Children under 12 years |
|
FD&C BLUE #2 LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, TALC, TITANIUM DIOXIDE
1-800-395-0689 (Mon-Fri 9AM-5PM EST)
Dist. by :
Bayer Healthcare LLC
Whippany, NJ 07981
ALL DAY STRONG®
ALEVE
HEADACHE PAIN
naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
Bayer
For temporary relief of headache pain
ACTUAL SIZE
STRENGTH TO LAST 12 HOURS
TABLETS
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 849728 | Aleve 220 MG Oral Tablet | PSN | 4 |
| 849574 | naproxen sodium 220 MG Oral Tablet | PSN | 4 |
| 849728 | naproxen sodium 220 MG Oral Tablet [Aleve] | SBD | 4 |
| 849574 | naproxen sodium 220 MG Oral Tablet | SCD | 4 |
| 849728 | Aleve 220 MG Oral Tablet | SY | 4 |
| 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0025866593510 | GTIN-13: 0025866593510 EAN-13: 0025866593510 GTIN-12: 025866593510 UPC-A: 025866593510 GTIN storage (14 digits): 00025866593510 | Aleve Headache Pain-24 Count Carton.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0041-01 | Aleve Headache Pain | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 0280-0041-01 | Aleve Headache Pain | 175 in 1 BOTTLE | TABLET | 175 | 4 | |
| 0280-0041-02 | Aleve Headache Pain | 50 in 1 BOTTLE | TABLET | 50 | 4 | |
| 0280-0041-02 | Aleve Headache Pain | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 0280-0041-03 | Aleve Headache Pain | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 0280-0041-03 | Aleve Headache Pain | 90 in 1 BOTTLE | TABLET | 90 | 4 | |
| 0280-0041-04 | Aleve Headache Pain | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 0280-0041-04 | Aleve Headache Pain | 24 in 1 BOTTLE | TABLET | 24 | 4 | |
| 0280-0041-05 | Aleve Headache Pain | 1 in 1 POUCH | TABLET | 1 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0280-0041 | 0280-0041-01, 0280-0041-02, 0280-0041-04, 0280-0041-03, 0280-0041-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| TALC | 7SEV7J4R1U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020204-002 | ALEVE | NAPROXEN SODIUM | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020204-002 | ALEVE | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 1994-01-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020204-002 | ALEVE | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 1994-01-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Aleve Headache Pain | NAPROXEN SODIUM | Bayer HealthCare LLC | c69f4926-c5cd-63a0-e053-2a95a90a2ca6 | 2025-12-04 | Warnings | 0280-0041-05 0280-0041-04 0280-0041-03 0280-0041-01 0280-0041-02 0280-0041 00280004101 00280004104 00280004105 00280004102 00280004103 45261837-3574-4376-e063-6394a90af7a7 c69f4926-c5cd-63a0-e053-2a95a90a2ca6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.