Aleve

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 01:19:38

Label at a glance#

ProductAleve Gelcaps

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 Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor

Storage and handling

each tablet contains: sodium 20 mg Store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).

Contacts and useful links#

PhoneLabel contact1-800-395-0689

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

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

INDICATIONS & USAGE SECTION

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 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.

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose

Adults and children 12 years and older	take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period
Children under 12 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: sodium 20 mg
Store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by:
Bayer HealthCare LLC
Whippany, NJ 07981

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASY OPEN

ARTHRITIS CAP

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer

PACKAGE NOT CHILD-RESISTANT

STRENGTH TO LAST 12 HOURS

160 GELCAPS

GELATIN COATED CAPSULE-SHAPED TABLETS

Front label

back label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849728	Aleve 220 MG Oral Tablet	PSN	16
849574	naproxen sodium 220 MG Oral Tablet	PSN	16
849728	naproxen sodium 220 MG Oral Tablet [Aleve]	SBD	16
849574	naproxen sodium 220 MG Oral Tablet	SCD	16
849728	Aleve 220 MG Oral Tablet	SY	16
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	16

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0280-6020-02	AleveGelcaps	1 in 1 CARTON	TABLET, COATED	1	16
0280-6020-02	AleveGelcaps	90 in 1 BOTTLE	TABLET, COATED	90	16
0280-6020-16	AleveGelcaps	160 in 1 BOTTLE	TABLET, COATED	160	16
0280-6020-20	AleveGelcaps	20 in 1 BOTTLE	TABLET, COATED	20	16
0280-6020-20	AleveGelcaps	1 in 1 CARTON	TABLET, COATED	1	16
0280-6020-40	AleveGelcaps	40 in 1 BOTTLE	TABLET, COATED	40	16
0280-6020-40	AleveGelcaps	1 in 1 CARTON	TABLET, COATED	1	16
0280-6020-80	AleveGelcaps	80 in 1 BOTTLE	TABLET, COATED	80	16
0280-6020-80	AleveGelcaps	1 in 1 CARTON	TABLET, COATED	1	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	1
naproxen	ACTIVE MOIETY	57Y76R9ATQ	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Aleve Gelcaps
NAPROXEN SODIUM
D&C YELLOW NO. 10
ALUMINUM OXIDE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
TALC
TITANIUM DIOXIDE
NAPROXEN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0280-6020	0280-6020-20, 0280-6020-40, 0280-6020-80, 0280-6020-16, 0280-6020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
D&C YELLOW NO. 10	35SW5USQ3G	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT

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 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route+dosage form 6 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
N020204-002	ALEVE	NAPROXEN SODIUM	220MG	TABLET / ORAL		RLD, RS	1994-01-11

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	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020204-002	ALEVE	EQ 200MG BASE	TABLET / ORAL	RLD, RS	1994-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020204-002	ALEVE	EQ 200MG BASE	TABLET / ORAL	RLD, RS	1994-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020204-002	ALEVE	220MG	TABLET / ORAL	RLD, RS	1994-01-11	`3a93d1ddd44b…`

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 Gelcaps	NAPROXEN SODIUM	Bayer HealthCare LLC.	0ad8bbb9-dd5f-4273-b085-ee3e5ed22613	2025-12-04	Warnings	Exact identifier ndc (package): 0280-6020-80 ndc (package): 0280-6020-16 ndc (package): 0280-6020-20 ndc (package): 0280-6020-02 ndc (package): 0280-6020-40 ndc (product): 0280-6020 ndc11 (package): 00280602040 ndc11 (package): 00280602016 ndc11 (package): 00280602020 ndc11 (package): 00280602002 ndc11 (package): 00280602080 spl id: 4526be49-a72d-1db7-e063-6394a90a1937 spl set id: 0ad8bbb9-dd5f-4273-b085-ee3e5ed22613

Reported adverse events (FAERS/openFDA)#

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