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
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
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
each tablet contains: sodium 20 mg store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Drug Facts
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
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.
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
| Adults and children 12 years and older |
|
| Children under 12 years | ask a doctor |
colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide
1-855-274-4122
Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
AUROHEALTH
NDC 58602-739-07
Naproxen Sodium Tablets, USP
220 mg (NSAID)
BACK AND MUSCLE PAIN
For temporary relief of minor back and
muscle aches and pains
STRENGTH TO LAST 12 HOURS
24 Tablets
AUROHEALTH
NDC 58602-739-07
**Compare to Aleve® Back and Muscle Pain
active ingredient
Naproxen Sodium Tablets, USP
220 mg (NSAID)
BACK AND MUSCLE PAIN
For temporary relief of minor back and muscle aches and pains
STRENGTH TO LAST 12 HOURS
24 Tablets
| 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 |
|---|---|---|---|---|---|---|
| 58602-739-07 | Naproxen Sodium BACK AND MUSCLE PAIN | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 5 | |
| 58602-739-07 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-12 | Naproxen Sodium BACK AND MUSCLE PAIN | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | 5 | |
| 58602-739-12 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-19 | Naproxen Sodium BACK AND MUSCLE PAIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 | |
| 58602-739-19 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-21 | Naproxen Sodium BACK AND MUSCLE PAIN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 | |
| 58602-739-21 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-25 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-25 | Naproxen Sodium BACK AND MUSCLE PAIN | 130 in 1 BOTTLE | TABLET, FILM COATED | 130 | 5 | |
| 58602-739-29 | Naproxen Sodium BACK AND MUSCLE PAIN | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | 5 | |
| 58602-739-29 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-34 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-34 | Naproxen Sodium BACK AND MUSCLE PAIN | 200 in 1 BOTTLE | TABLET, FILM COATED | 200 | 5 | |
| 58602-739-38 | Naproxen Sodium BACK AND MUSCLE PAIN | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 5 | |
| 58602-739-38 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-40 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-40 | Naproxen Sodium BACK AND MUSCLE PAIN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 5 | |
| 58602-739-44 | Naproxen Sodium BACK AND MUSCLE PAIN | 400 in 1 BOTTLE | TABLET, FILM COATED | 400 | 5 | |
| 58602-739-78 | Naproxen Sodium BACK AND MUSCLE PAIN | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 58602-739-78 | Naproxen Sodium BACK AND MUSCLE PAIN | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-739 | 58602-739-07, 58602-739-12, 58602-739-78, 58602-739-21, 58602-739-25, 58602-739-29, 58602-739-34, 58602-739-38, 58602-739-40, 58602-739-44, 58602-739-19 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 2--ALUMINUM LAKE | 4AQJ3LG584 | IACT |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE 200 | 5XDI2TS1EZ | IACT |
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|---|
| A205497-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 |
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 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A205497-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2016-03-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A205497-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2016-03-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 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 Sodium BACK AND MUSCLE PAIN | NAPROXEN SODIUM | Aurohealth LLC | 666e3c6a-e571-4124-84d8-0142db1012dc | 2025-05-26 | Warnings | 58602-739-21 58602-739-78 58602-739-19 58602-739-29 58602-739-07 58602-739-40 58602-739-34 58602-739-12 58602-739-44 58602-739-25 58602-739-38 58602-739 58602073938 58602073907 58602073921 58602073940 58602073978 58602073925 58602073929 58602073934 58602073919 58602073944 58602073912 ff1010cd-0fc3-4e54-8a03-f3dfa1417926 666e3c6a-e571-4124-84d8-0142db1012dc |
Adverse event summaries are temporarily unavailable. Other product information remains available.