Naproxen Sodium Tablets, USP 220 mg

Manufacturer: Polygen Pharmaceuticals LLC | Marksans Pharma Limited
Effective date: 2013-06-25
Label type: Human OTC Drug Label
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:35:46

Label at a glance#

ProductNaproxen Sodium

Active ingredientNAPROXEN SODIUM

Label structure17 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

store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-291-7337

PhoneFDA MedWatch1-800-FDA-1088

PhoneLabel contact1-800-291-7337

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Use(s)

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

WARNINGS SECTION

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

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, or kidney disease
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have asthma

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor's care for any serious condition
taking any other drug

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask 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
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 pill is stuck in your throat

Pregnancy/Breastfeeding

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 (1-800-222-1222).

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

Storage

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

Other information

OTHER SAFETY INFORMATION

each tablet contains: sodium 20 mg
side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.

Questions or comments

OTC - QUESTIONS SECTION

1-800-291-7337

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAPROXEN SODIUM TABLETS:

Carton PDP:

NDC: 52605-141-01

Compare to the active ingredient in Aleve^®

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

100 TABLETS

Bottle Label PDP:

NDC: 52605-141-01

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

STRENGTH TO LAST 12 HOURS

100 TABLETS

NAPROXEN SODIUM CAPLETS:

Carton PDP:

NDC: 52605-144-01

Compare to the active ingredient in Aleve^®

ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

100 CAPLETS (CAPSULE- SHAPED TABLETS)

Naproxensodium

Bottle Label PDP:

NDC: 52605-144-01

ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

100 CAPLETS (CAPSULE- SHAPED TABLETS)

Naproxensodiumcaplets

NAPROXEN SODIUM CAPLETS:

Carton PDP:

NDC: 52605-144-24

Compare to the active ingredient in Aleve^®

ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

24 CAPLETS (CAPSULE- SHAPED TABLETS)

naproxensodium24

Bottle Label PDP:

NDC: 52605-144-24

ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

24 CAPLETS (CAPSULE- SHAPED TABLETS)

naproxensodium24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	6
849574	naproxen sodium 220 MG Oral Tablet	SCD	6
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	6

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52605-141-01	2021-01-29	C162847	48780-1	9855d018-e3d2-cd31-e053-dbdaa90ab51a	Naproxen Sodium Tablets, USP 220 mg
52605-144-01	2021-01-29	C162847	48780-1	9855d018-e3d2-cd31-e053-dbdaa90ab51a	Naproxen Sodium Tablets, USP 220 mg
52605-144-24	2021-01-29	C162847	48780-1	9855d018-e3d2-cd31-e053-dbdaa90ab51a	Naproxen Sodium Tablets, USP 220 mg
52605-141-01	2019-11-27	C162847	48780-1	9855d018-e3d2-cd31-e053-dbdaa90ab51a	Naproxen Sodium Tablets, USP 220 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52605-141-01	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	6
52605-141-01	Naproxen Sodium	100 in 1 BOTTLE	TABLET, COATED	100	6
52605-144-01	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	6
52605-144-01	Naproxen Sodium	100 in 1 BOTTLE	TABLET, COATED	100	6
52605-144-24	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	6
52605-144-24	Naproxen Sodium	24 in 1 BOTTLE	TABLET, COATED	24	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-141	NAPROXEN SODIUM TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]	6	Legacy NDC, 2 package rows	20130626_e8720904-9ac0-46c0-b220-730e373505a7.zip
52605-144	NAPROXEN SODIUM TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]	6	Legacy NDC, 4 package rows	20130626_e8720904-9ac0-46c0-b220-730e373505a7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	6
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	6

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Naproxen Sodium
NAPROXEN
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52605-144	52605-144-01, 52605-144-24
52605-141	52605-141-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
COLLOIDAL SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
COLLOIDAL SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT

Source Document#

Source XML · Source PDF

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 5 · 246 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FOR SUSPENSION / ORAL		1875 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, COATED PELLETS / ORAL		198 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, ORALLY DISINTEGRATING / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 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 43.

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
A090545-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-03-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090545-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090545-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`f41ea6bd6efb…`

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
b06d4755-1fbf-4fcf-9075-cb1691292aad			e8720904-9ac0-46c0-b220-730e373505a7	2013-06-25	Warnings	Exact identifier spl id: b06d4755-1fbf-4fcf-9075-cb1691292aad spl set id: e8720904-9ac0-46c0-b220-730e373505a7

Reported adverse events (FAERS/openFDA)#

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