Indications and uses
temporarily relieves minor aches and pains due to: minor pain or arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Naproxen Sodium
- Manufacturer
- AmerisourceBergen (Good Neighbor Pharmacy) 46122
- Effective date
- 2018-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:42:38
Label at a glance#
ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure10 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). read all warnings and directions before use. Keep carton.
Contacts and useful links#
Label contents#
Full prescribing information#
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 or 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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
Heart attack and stroke warnings: 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
- the 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 have problems or serious side effects from taking pain relievers or fever reducers
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- 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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problem or stroke
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- 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
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. (1-800-222-1222)
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:
- 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 24-hour period
- children under 12 years: ask a doctor
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).
- read all warnings and directions before use. Keep carton.
Inactive ingredients
FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol 600, povidone K30, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to Aleve® active ingredient
Naproxen Sodium
Capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer
Liquid Filled Capsules
†This product is not manufactured or distributed by Bayer HealthCare, LLC., distributor of Aleve®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087
Product Label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-283-58 | EA - Each | 46122-283 | 85e501a0-3d3c-41b4-ab10-f05f22f7e9f8 | 1 | 2022-06-06 |
| 46122-283-60 | EA - Each | 46122-283 | e6966deb-e028-45c9-8c65-406c937137d2 | 1 | 2017-09-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Naproxen Sodium
- NAPROXEN
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- LACTIC ACID
- MANNITOL
- POLYETHYLENE GLYCOL 600
- POVIDONE K30
- PROPYLENE GLYCOL
- WATER
- SORBITAN
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 46122-283 | 46122-283-60, 46122-283-58 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, EXTENDED RELEASE / ORAL | 160 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAVENOUS | 2.5 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / TOPICAL | 4 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / BUCCAL | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, LIQUID FILLED / ORAL | 101 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GEL / OPHTHALMIC | 25 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 178 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | TABLET, EXTENDED RELEASE / ORAL | 2.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / ORAL | 148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | AEROSOL, FOAM / TOPICAL | 11 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE / ORAL | 202 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER / ORAL | 4352 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 15400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| POLYETHYLENE GLYCOL 600 | POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | INJECTION / INTRAVENOUS | 5 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | INJECTION / INTRAMUSCULAR | 0.59 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE / ORAL | 1328 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE / ORAL | 540 mg |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021920-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2006-02-17 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 10022344 | 2026-03-03 | U-1731 | Drug product | 2018-07-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 10022344 | 2026-03-03 | U-1732 | Drug product | 2018-07-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 10028925 | 2026-03-03 | U-1731 | Drug product | 2018-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 10028925 | 2026-03-03 | U-1732 | Drug product | 2018-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 11090280 | 2026-03-03 | U-1731 | Drug product | 2021-08-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 11090280 | 2026-03-03 | U-1732 | Drug product | 2021-08-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 9693978 | 2026-03-03 | Drug product | 2017-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021920-001 | 9693979 | 2026-03-03 | Drug product | 2017-11-13 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| 0b5def13-65a4-4aa5-9d57-b3e6bd33c9ef | 4bc843ff-9d29-4d3d-a7a8-e6e87b9b96bc | 2018-12-13 | Warnings | 0b5def13-65a4-4aa5-9d57-b3e6bd33c9ef 4bc843ff-9d29-4d3d-a7a8-e6e87b9b96bc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.