Indications and uses
temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ menstrual cramps ■ headache ■ toothache ■ the common cold temporarily reduces fever
temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ 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 caplet every 8 to 12 hours while symptoms last ■ for the first dose you may take 2 caplets within the first hour ■ do not exceed 2 caplets in any 8- to 12- hour period ■ do not exceed 3 caplets in a 24- hour period children under 12 years, ■ ask a doctor
(in each caplet)
Naproxen sodium 220 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain Reliever/Fever reducer
■ minor pain of arthritis
■ muscular aches
■ backache
■ menstrual cramps
■ headache
■ toothache
■ the common cold
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
■ feel faint
■ vomit blood
■ have bloody or black stools
■ have stomach pain that does not get better
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children 12 years and older,
■ take 1 caplet every 8 to 12 hours while symptoms last
■ for the first dose you may take 2 caplets within the first hour
■ do not exceed 2 caplets in any 8- to 12- hour period
■ do not exceed 3 caplets in a 24- hour period
children under 12 years,
■ ask a doctor
1-888-287-1915
FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide.
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49035-761-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0636-f424-e053-dadaa90a57ce | Naproxen Tablets |
| 49035-762-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0636-f424-e053-dadaa90a57ce | Naproxen Tablets |
| 49035-762-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0636-f424-e053-dadaa90a57ce | Naproxen Tablets |
| 49035-762-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0636-f424-e053-dadaa90a57ce | Naproxen Tablets |
| 49035-762-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0636-f424-e053-dadaa90a57ce | Naproxen Tablets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-761-21 | Naproxen Sodium | 225 in 1 BOTTLE | TABLET | 225 | 3 | |
| 49035-762-10 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 49035-762-21 | Naproxen Sodium | 225 in 1 BOTTLE | TABLET | 225 | 3 | |
| 49035-762-24 | Naproxen Sodium | 24 in 1 BOTTLE | TABLET | 24 | 3 | |
| 49035-762-30 | Naproxen Sodium | 300 in 1 BOTTLE | TABLET | 300 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-761 | NAPROXEN SODIUM TABLET [WAL-MART STORES, INC.,] | 3 | Legacy NDC, 1 package rows | 20170503_3d963242-a7b5-1ea4-e054-00144ff88e88.zip |
| 49035-762 | NAPROXEN SODIUM TABLET [WAL-MART STORES, INC.,] | 3 | Legacy NDC, 4 package rows | 20170503_3d963242-a7b5-1ea4-e054-00144ff88e88.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49035-762 | 49035-762-24, 49035-762-10, 49035-762-21, 49035-762-30 |
| 49035-761 | 49035-761-21 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A091353-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 |
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 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091353-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-09-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091353-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-09-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 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 |
|---|---|---|---|---|---|---|
| 4a11d025-58f4-070f-e054-00144ff88e88 | 3d963242-a7b5-1ea4-e054-00144ff88e88 | 2017-03-06 | Warnings | 4a11d025-58f4-070f-e054-00144ff88e88 3d963242-a7b5-1ea4-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.