Indications and uses
temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis toothache the common cold menstrual cramps headache temporarily reduces fever
temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis toothache the common cold menstrual cramps headache 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°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) use by expiration date on package
Naproxen sodium 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 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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
QUALITY
+PLUS
NDC 50844-714-16
†Compare to
active ingredient in
Aleve® Back & Muscle
Pain Tablets
NAPROXEN
BACK AND MUSCLE PAIN
NAPROXEN SODIUM
TABLETS, 220 mg
PAIN RELIEVER/FEVER
REDUCER (NSAID)
For temporary relief of minor back
and muscle aches and pains
Strength to last
12 hours
1000
Coated Tablets
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Aleve®
Back & Muscle Pain Tablets. 50844 REV1221B41716
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0350844714169 | GTIN-13: 0350844714169 EAN-13: 0350844714169 GTIN-12: 350844714169 UPC-A: 350844714169 GTIN storage (14 digits): 00350844714169 | quality-plus-44-417-back-and-muscle-pain-1.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 |
|---|---|---|---|---|---|---|
| 50844-714-14 | Naproxen Back and Muscle Pain | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | 11 | |
| 50844-714-16 | Naproxen Back and Muscle Pain | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | 11 | |
| 50844-714-19 | Naproxen Back and Muscle Pain | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | 11 | |
| 50844-714-19 | Naproxen Back and Muscle Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 11 | |
| 50844-714-56 | Naproxen Back and Muscle Pain | 25 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 25 | 11 | |
| 50844-714-98 | Naproxen Back and Muscle Pain | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | 11 | |
| 50844-714-99 | Naproxen Back and Muscle Pain | 8 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 8 | 11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50844-714 | 50844-714-99, 50844-714-98, 50844-714-19, 50844-714-56, 50844-714-14, 50844-714-16 |
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 |
|---|---|---|---|---|---|---|---|
| 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 Back and Muscle Pain | NAPROXEN SODIUM | L.N.K. International, Inc. | 68944663-0dc0-4d3a-a36b-019061bdbfa0 | 2026-03-09 | Warnings | 50844-714-19 50844-714-16 50844-714-56 50844-714-14 50844-714-98 50844-714-99 50844-714 50844071414 50844071419 50844071456 50844071498 50844071416 50844071499 bc397444-6e0e-4b4e-8f03-d6372588d8ab 68944663-0dc0-4d3a-a36b-019061bdbfa0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.