Aleve

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-06-01 01:19:44

Label at a glance#

ProductAleve Easy Open Arthritis Cap

Active ingredientNAPROXEN SODIUM

Label structure11 sections

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

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 directions and warnings before use. Keep carton.

Contacts and useful links#

PhoneLabel contact1-800-395-0689

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) ¹

1 nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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 SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

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
you have difficulty swallowing
it feels like the pill is stuck in your throat
redness or swelling is present in the painful area
any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

do not take more than directed
the smallest effective doses hould 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Other information

STORAGE AND HANDLING SECTION

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.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

SPL UNCLASSIFIED SECTION

Distributed by:

Whippany

Bayer Healthcare LLC

Whippany, NJ 07981

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EZ OPEN ARHTRITIS CAP

ALL DAY STRONG®

ALEVE ®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

CAPSULES

(LIQUID FILLED CAPSULES)

Carton 80 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1112233	Aleve 220 MG Oral Capsule	PSN	11
1112231	naproxen sodium 220 MG Oral Capsule	PSN	11
1112233	naproxen sodium 220 MG Oral Capsule [Aleve]	SBD	11
1112231	naproxen sodium 220 MG Oral Capsule	SCD	11
1112233	Aleve 220 MG (naproxen 200 MG) Oral Capsule	SY	11
1112233	Aleve 220 MG Oral Capsule	SY	11
1112231	naproxen sodium 220 MG (as naproxen 200 MG) Oral Capsule	SY	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAPROXEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0325866535900	GTIN-13: 0325866535900 EAN-13: 0325866535900 GTIN-12: 325866535900 UPC-A: 325866535900 GTIN storage (14 digits): 00325866535900	86942119_Aleve_80ct_Ctn_R_Page_1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0280-6091-80	AleveEasy Open Arthritis Cap	80 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	80		11
0280-6091-80	AleveEasy Open Arthritis Cap	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0280-6091-80	EA - Each	0280-6091	028e7dae-23b3-4d1d-87b4-5640ba63b411	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
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 400	INACTIVE INGREDIENT	B697894SGQ	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.

DailyMed product names page 1 of 1 · 14 matching rows.

Aleve Easy Open Arthritis Cap
Naproxen Sodium
FD&C BLUE NO. 1
GELATIN
GLYCERIN
LACTIC ACID
MANNITOL
POLYETHYLENE GLYCOL 400
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
NAPROXEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0280-6091	0280-6091-80

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
LACTIC ACID	33X04XA5AT	IACT
MANNITOL	3OWL53L36A	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE K30	U725QWY32X	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 3 · 148 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
gelatin	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL		1086 mg	Exact identifier — unii+route 52 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route 40 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 40 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 36 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / ORAL		7093 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, FOR SUSPENSION / ORAL		7621 mg	Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 36 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	CAPSULE, LIQUID FILLED / ORAL		101 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii+route 52 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, FOR SUSPENSION / ORAL		7621 mg	Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route 52 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 36 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	CAPSULE / ORAL		132 mg	Exact identifier — unii+route 8 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	CAPSULE / ORAL		132 mg	Exact identifier — unii+route 8 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, DELAYED RELEASE / ORAL		2043 mg	Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii+route 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii+route 40 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	TABLET / ORAL	ADJ PH		Exact identifier — unii+route 8 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii+route 52 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii+route 52 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route 40 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route 40 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	CONCENTRATE / ORAL	50 mg/5ml		Exact identifier — unii+route 8 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	LOZENGE / ORAL		20546 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii+route 52 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	SOLUTION / ORAL		192 mg	Exact identifier — unii+route 8 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii+route 36 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, DELAYED RELEASE / ORAL		639 mg	Exact identifier — unii+route 52 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii+route 40 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 36 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii+route 52 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 36 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii+route 40 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / ORAL		7093 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii+route 52 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	GRANULE, FOR SUSPENSION / ORAL		6000 mg	Exact identifier — unii+route 52 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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#

Patent history page 1 of 9 · 337 observed states.

Captured, Edition, Application-product table
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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3b5442c6-c6e1-4df3-8cec-40bbb4ec469f	2025-12-04	Warnings	Exact identifier ndc (package): 0280-6091-80 ndc (product): 0280-6091 ndc11 (package): 00280609180 spl id: 4526c253-b572-1d84-e063-6394a90ae3f9 spl set id: 3b5442c6-c6e1-4df3-8cec-40bbb4ec469f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Aleve

Label at a glance#

Indications and uses

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient (in each capsule)

Purposes

Uses

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DOSAGE & ADMINISTRATION SECTION

Inactive ingredients

Other information

Questions or comments?

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

Orange Book application contexts#

Orange Book products#

Orange Book patents#

Observed Orange Book product history#

Observed Orange Book patent history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#