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
naproxen sodium - Bionpharma Inc. | Patheon Softgels Inc.
- Manufacturer
- Bionpharma Inc. | Patheon Softgels Inc.
- Effective date
- 2026-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:56:58
Label at a glance#
Productnaproxen sodium
Active ingredientNAPROXEN SODIUM
Label structure11 sections
Dosage and administration
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 ...
Storage and handling
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) protect from light read all directions and warnings before use.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each capsule)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
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
Warnings
Allergy alert:Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters.
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:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
SPL UNCLASSIFIED SECTION
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.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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: |
|
| children under 12 years: |
|
Other information
- 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)
- protect from light
- read all directions and warnings before use.
Inactive ingredients
FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments?
1-888-235-2466(Mon - Fri 9AM - 5PM EST)
SPL UNCLASSIFIED SECTION
Do not use if printed safety seal under cap is torn or missing.
***This product is not manufactured or distributed by the owners of ALEVE ®Liquid Gels.
Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
L0000707 Lot/Exp
R0223
PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton
*** compare tothe active ingredient in ALEVE ® Liquid Gels
a+health
naproxen sodiumcapsules, 220 mg(NSAID)
pain reliever/fever reducer
180 capsules**
strength to last 12 hours
**liquid-filled capsule
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| 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 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69452-259-21 | naproxen sodium | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 5 | |
| 69452-259-22 | naproxen sodium | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 5 | |
| 69452-259-25 | naproxen sodium | 180 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 180 | 5 | |
| 69452-259-78 | naproxen sodium | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 69452-259-78 | naproxen sodium | 80 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 80 | 5 |
Products#
Every source-derived product name is available through these pages.
- naproxen sodium
- PROPYLENE GLYCOL
- WATER
- SORBITAN
- SORBITOL
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- LACTIC ACID
- MANNITOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- NAPROXEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69452-259 | 69452-259-78, 69452-259-22, 69452-259-25, 69452-259-21 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021920-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 |
| N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 |
| N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 |
| N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 |
| N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 |
| N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 |
| N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | |
| N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 |
Observed Orange Book product history#
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 | 31067a03dcf5… |
openFDA label cross-check#
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 | Bionpharma Inc. | 9343c79f-9994-4599-bcfe-0a93e49d726e | 2026-05-12 | Warnings | 69452-259-21 69452-259-22 69452-259-78 69452-259-25 69452-259 69452025925 69452025921 69452025978 69452025922 51a1be90-a17c-8e7f-e063-6394a90a1cb0 9343c79f-9994-4599-bcfe-0a93e49d726e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.