Indications and uses
temporarily relieves minor aches and pain due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever
temporarily relieves minor aches and pain due to: backache muscular aches minor pain of arthritis menstrual cramps headache 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
Store at 20-25 o C (68-77 o F). Avoid high humidity and excessive heat above 40 0 C (104 0 F)
Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
temporarily relieves minor aches and pain due to:
temporarily reduces fever
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.
leg swelling chest pain
slurred speech trouble breathing
weakness in one part or side of body
If pregnant or breast-feeding, ask a health professional
before use. It is especially important not to use naproxen
sodium at 20 weeks 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 (1-800-222-1222) right away.
croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, silicon dioxide, talc, titanium dioxide
Call 1-800-540-3765
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
|---|---|---|---|---|---|---|
| 57896-954-01 | Naproxen | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 57896-954-05 | Naproxen | 50 in 1 BOTTLE | TABLET | 50 | 4 | |
| 57896-954-50 | Naproxen | 500 in 1 BOTTLE | TABLET | 500 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-954-01 | EA - Each | 57896-954 | 3674a1eb-0ece-4426-a2f7-806088afe336 | 1 | 2020-03-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57896-954 | 57896-954-01, 57896-954-05, 57896-954-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A204872-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 |
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 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A204872-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2017-01-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A204872-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2017-01-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 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 |
|---|---|---|---|---|---|---|
| Naproxen | NAPROXEN SODIUM | Geri-Care Pharmaceutical Corp | 9a61d544-e46d-6703-e053-2a95a90a32fd | 2025-02-27 | Warnings | 57896-954-05 57896-954-01 57896-954-50 57896-954 57896095450 57896095405 57896095401 2f2538e8-183f-1d4f-e063-6294a90af917 9a61d544-e46d-6703-e053-2a95a90a32fd |
Adverse event summaries are temporarily unavailable. Other product information remains available.