NAPROXEN SODIUM TABLETS USP, 220 mg

Manufacturer
Dr.Reddy's Laboratories Limited
Effective date
2025-06-03
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:02:14

Label at a glance#

ProductNaproxen Sodium
Active ingredientNaproxen Sodium
Label structure15 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

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PAIN RELIEVER / FEVER REDUCER (NSAID)

Drug Facts

Active ingredient (in each tablet/caplet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium USP, 220 mg
(naproxen USP, 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

WARNINGS SECTION

SPL UNCLASSIFIED 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.

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 everyday while using this product
  • take more or for a longer time than directed

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Do not use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 paint
    • 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 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.

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

SPL UNCLASSIFIED SECTION

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

Rev: 03/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Caplets

Container

capletcontainercapletcontainer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Carton

capletcartoncapletcarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tablets

Containertabletcontainertabletcontainer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Cartontabletcartontabletcarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN13
849574naproxen sodium 220 MG Oral TabletSCD13
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-272-01Naproxen Sodium100 in 1 BOTTLETABLET, COATED10013
55111-272-01Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-02Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-02Naproxen Sodium200 in 1 BOTTLETABLET, COATED20013
55111-272-05Naproxen Sodium500 in 1 BOTTLETABLET, COATED50013
55111-272-05Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-24Naproxen Sodium24 in 1 BOTTLETABLET, COATED2413
55111-272-24Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-50Naproxen Sodium50 in 1 BOTTLETABLET, COATED5013
55111-272-50Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-273-01Naproxen Sodium100 in 1 BOTTLETABLET, COATED10013
55111-273-01Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-273-02Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-273-02Naproxen Sodium200 in 1 BOTTLETABLET, COATED20013
55111-273-05Naproxen Sodium500 in 1 BOTTLETABLET, COATED50013
55111-273-05Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-273-24Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-273-24Naproxen Sodium24 in 1 BOTTLETABLET, COATED2413
55111-273-40Naproxen Sodium400 in 1 BOTTLETABLET, COATED40013
55111-273-40Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-273-50Naproxen Sodium50 in 1 BOTTLETABLET, COATED5013
55111-273-50Naproxen Sodium1 in 1 CARTONTABLET, COATED113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Naproxen SodiumACTIVE INGREDIENT9TN87S3A3C3
NaproxenACTIVE MOIETY57Y76R9ATQ3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK3
hypromellosesINACTIVE INGREDIENT3NXW29V3WO3
magnesium stearateINACTIVE INGREDIENT70097M6I303
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1A3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
povidoneINACTIVE INGREDIENTFZ989GH94E3
talcINACTIVE INGREDIENT7SEV7J4R1U3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP3

Products#

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

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

NDC Codes#

Ingredients#

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

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

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 · 104 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
13 equally ranked IID candidates
povidonePOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
13 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075168-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL1998-07-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075168-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1998-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075168-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1998-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMDr.Reddy's Laboratories Limitedaca5d497-fbc6-464d-2dee-25c50e11bc782025-06-03WarningsExact identifier
ndc (package): 55111-272-24
ndc (package): 55111-273-50
ndc (package): 55111-272-50
ndc (package): 55111-272-05
ndc (package): 55111-273-01
ndc (package): 55111-273-24
ndc (package): 55111-272-01
ndc (package): 55111-273-40
ndc (package): 55111-272-02
ndc (package): 55111-273-05
ndc (package): 55111-273-02
ndc (product): 55111-273
ndc (product): 55111-272
ndc11 (package): 55111027205
ndc11 (package): 55111027301
ndc11 (package): 55111027350
ndc11 (package): 55111027324
ndc11 (package): 55111027201
ndc11 (package): 55111027224
ndc11 (package): 55111027340
ndc11 (package): 55111027202
ndc11 (package): 55111027302
ndc11 (package): 55111027305
ndc11 (package): 55111027250
spl id: 45f79372-39c7-ae59-c119-51aece645ae0
spl set id: aca5d497-fbc6-464d-2dee-25c50e11bc78

Reported adverse events (FAERS/openFDA)#

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