NAPROXEN SODIUM- naproxen sodium tablet,coated

Manufacturer: MARKSANS PHARMA LIMITED
Effective date: 2023-06-09
Label type: Human OTC Drug Label
Version: 8
Source: full-release
Hydrated at: 2026-05-31 23:55:14

Label at a glance#

ProductNaproxen Sodium

Active ingredientNAPROXEN SODIUM

Label structure16 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

Dosage and administration

For Tablets: • 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 und...

Storage and handling

For Tablets: • each tablet contains: sodium 20 mg • store at 20-25ºC (68-77ºF). • avoid high humidity and excessive heat above 40°C (104°F). For Caplets: • each caplet 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#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-376-4271

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

For Tablets:
Active ingredient (in each tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

For Caplets:
Active ingredient (in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

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

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

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 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 at 20 weeks or later in 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

For Tablets:

• 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

For Caplets:

• 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 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period
Children under 12 years	• ask a doctor

Other information

STORAGE AND HANDLING SECTION

For Tablets:

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

For Caplets:

• each caplet 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

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

Questions or comments?

SPL UNCLASSIFIED SECTION

call toll free 1-877-376-4271

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue, Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, Goa - 403722, India.

Mfg. Lic. No.: GO/DRUGS/515

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25000-141-43
Naproxen Sodium Tablets, USP 220 mg
10’s count bottle label

NDC 25000-141-43
Naproxen Sodium Tablets, USP 220 mg
10’s count carton label

nap-sod-tablets-ifc-10s

NDC 25000-141-02
Naproxen Sodium Tablets, USP 220 mg
24’s count bottle label

nap-sod-tabs-bottle-24s

NDC 25000-141-02
Naproxen Sodium Tablets, USP 220 mg
24’s count carton label

nap-sod-tablets-ifc-24s

NDC 25000-141-14
Naproxen Sodium Tablets, USP 220 mg
1000’s count bottle label

nap-sod-tabs-bottle-1000s

NDC 25000-144-14
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
1000’s count bottle label

NDC 25000-144-43
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
10’s count bottle label

nap-sod-caps-bottle-10s

NDC 25000-144-43
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
10’s count carton label

NDC 25000-144-02
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
24’s count bottle label

nap-sod-caps-bottle-24s

NDC 25000-144-02
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
24’s count carton label

nap-sod-caplets-ifc-24s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	8
849574	naproxen sodium 220 MG Oral Tablet	SCD	8
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25000-141-02	Naproxen Sodium	1 in 1 CARTON	TABLET	1	8
25000-141-02	Naproxen Sodium	160 in 1 BOX	TABLET	160	8
25000-141-14	Naproxen Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	8
25000-141-26	Naproxen Sodium	2 in 1 BOX	TABLET	2	8
25000-141-26	Naproxen Sodium	1600 in 1 BAG	TABLET	1600	8
25000-141-30	Naproxen Sodium	6500 in 1 BAG	TABLET	6500	8
25000-141-30	Naproxen Sodium	6 in 1 BOX	TABLET	6	8
25000-141-43	Naproxen Sodium	10 in 1 BOTTLE	TABLET	10	8
25000-141-98	Naproxen Sodium	1 in 1 BOX	TABLET	1	8
25000-141-98	Naproxen Sodium	32165 in 1 BAG	TABLET	32165	8
25000-144-02	Naproxen Sodium	1 in 1 CARTON	TABLET	1	8
25000-144-02	Naproxen Sodium	160 in 1 BOX	TABLET	160	8
25000-144-14	Naproxen Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	8
25000-144-20	Naproxen Sodium	4 in 1 BOX	TABLET	4	8
25000-144-20	Naproxen Sodium	6500 in 1 BAG	TABLET	6500	8
25000-144-30	Naproxen Sodium	6 in 1 BOX	TABLET	6	8
25000-144-30	Naproxen Sodium	6500 in 1 BAG	TABLET	6500	8
25000-144-43	Naproxen Sodium	10 in 1 BOTTLE	TABLET	10	8
25000-144-98	Naproxen Sodium	1 in 1 BOX	TABLET	1	8
25000-144-98	Naproxen Sodium	32165 in 1 BAG	TABLET	32165	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25000-141	NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]	8	Current NDC, Legacy NDC, 10 package rows	20230615_48cb1363-ff12-40ee-a87a-2252dfbf8ff7.zip
25000-144	NAPROXEN SODIUM (NAPROXEN SODIUM TABLET, COATED) TABLET NAPROXEN SODIUM (NAPROXEN SODIUM, COATED TABLETS) TABLET [MARKSANS PHARMA LIMITED]	8	Current NDC, Legacy NDC, 10 package rows	20230615_48cb1363-ff12-40ee-a87a-2252dfbf8ff7.zip

DailyMed Socrata Ingredients#

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Naproxen Sodium
Naproxen Sodium Tablet, coated
NAPROXEN
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
TITANIUM DIOXIDE
Naproxen Sodium, Coated Tablets

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
25000-141	25000-141-14, 25000-141-26, 25000-141-30, 25000-141-02, 25000-141-43, 25000-141-98
25000-144	25000-144-14, 25000-144-20, 25000-144-30, 25000-144-02, 25000-144-43, 25000-144-98

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
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
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	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 · 112 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL	25 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 14 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 14 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
Naproxen Sodium	NAPROXEN SODIUM, COATED TABLETS	MARKSANS PHARMA LIMITED	48cb1363-ff12-40ee-a87a-2252dfbf8ff7	2023-06-09	Warnings	Exact identifier ndc (package): 25000-141-30 ndc (package): 25000-141-02 ndc (package): 25000-141-43 ndc (package): 25000-144-20 ndc (package): 25000-144-43 ndc (package): 25000-141-14 ndc (package): 25000-144-14 ndc (package): 25000-144-02 ndc (package): 25000-141-98 ndc (package): 25000-144-98 ndc (package): 25000-141-26 ndc (package): 25000-144-30 ndc (product): 25000-144 ndc (product): 25000-141 ndc11 (package): 25000014430 ndc11 (package): 25000014414 ndc11 (package): 25000014443 ndc11 (package): 25000014420 ndc11 (package): 25000014114 ndc11 (package): 25000014402 ndc11 (package): 25000014130 ndc11 (package): 25000014126 ndc11 (package): 25000014102 ndc11 (package): 25000014198 ndc11 (package): 25000014498 ndc11 (package): 25000014143 spl id: 1e0b6883-f02c-4259-b905-9716dd72bcbf spl set id: 48cb1363-ff12-40ee-a87a-2252dfbf8ff7

Reported adverse events (FAERS/openFDA)#

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