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 if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a ...
each capsule contains: sodium 20 mg store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) read all directions and warnings before use. Keep carton.
Drug Facts
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
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 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.
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#1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide, white ink
Call toll free: 1-855-215-8180
Naproxen Sodium 220 mg Bulk
NDC: 53345-042-01
Each softgel contains: Naproxen Sodium 220 mg
CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
Quantity: 5,000 Capsules
MADE IN CHINA
IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).
| 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 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-042-01 | NAPROXEN SODIUM | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 53345-042-01 | NAPROXEN SODIUM | 5000 in 1 BAG | CAPSULE, LIQUID FILLED | 5000 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53345-042 | 53345-042-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIM |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| BUTYL ALCOHOL | 8PJ61P6TS3 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | 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 |
|---|---|---|---|---|---|---|---|
| A208363-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 |
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 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 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 | NAPROXEN SODIUM | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 1d5981dd-e3f5-48a3-a5f1-ce49689cdfac | 2019-11-08 | Warnings | 53345-042-01 53345-042 53345004201 1b92fe6c-7407-40e0-bcb2-27a62f4399a9 1d5981dd-e3f5-48a3-a5f1-ce49689cdfac |
Adverse event summaries are temporarily unavailable. Other product information remains available.