Naproxen Sodium Tablets

Manufacturer
Granules India Limited
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:04:01

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 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 each table...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

INDICATIONS AND USAGE

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 DOCTOR

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 DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

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

WHEN USING

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

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

PREGNANCY 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.

DOSAGE AND ADMINISTRATION

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 oldertake 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 yearsask a doctor

Information for Patients

  • each tablet contains: sodium 20 mg
  • store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • do not use if foil seal on bottle opening is missing or broken.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

QUESTIONS

OTC - QUESTIONS SECTION

1-877-770-3183 Mon – Fri 9:00 AM to 4:00 PM EST

M.L. 37/RR/AP/2003/F/R

MADE IN INDIA

Manufactured By:

Granules India Limited

2nd Floor 3rd Block, My Home hub

Madhapur, Hyderabad – 500 081, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C:\Users\Administrator\Desktop\spl sci\spl2\nap-sod capsule-shaped-tablets.jpgC:\Users\Administrator\Desktop\spl sci\spl2\nap-sod capsule-shaped-tablets.jpgC:\Users\Administrator\Desktop\spl sci\spl2\nap-sod tablets.jpgC:\Users\Administrator\Desktop\spl sci\spl2\nap-sod tablets.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN7
849574naproxen sodium 220 MG Oral TabletSCD7
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY7

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62207-750-412025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-422025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-432025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-442025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-452025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-472025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-492025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-512025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-522025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-750-532025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-412025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-422025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-432025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-442025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-452025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-472025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-492025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-512025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-522025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets
62207-753-532025-01-30C16284748780-12cef2736-65a3-d83d-e063-dadaa90ab31fNaproxen Sodium Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-750-41Naproxen Sodium24 in 1 BOTTLETABLET247
62207-750-42Naproxen Sodium50 in 1 BOTTLETABLET507
62207-750-43Naproxen Sodium43 in 1 BOTTLETABLET437
62207-750-44Naproxen Sodium150 in 1 BOTTLETABLET1507
62207-750-45Naproxen Sodium200 in 1 BOTTLETABLET2007
62207-750-47Naproxen Sodium500 in 1 BOTTLETABLET5007
62207-750-49Naproxen Sodium1000 in 1 BOTTLETABLET10007
62207-750-51Naproxen Sodium10 in 1 BOTTLETABLET107
62207-750-52Naproxen Sodium300 in 1 BOTTLETABLET3007
62207-750-53Naproxen Sodium400 in 1 BOTTLETABLET4007
62207-753-41Naproxen Sodium24 in 1 BOTTLETABLET247
62207-753-42Naproxen Sodium50 in 1 BOTTLETABLET507
62207-753-43Naproxen Sodium43 in 1 BOTTLETABLET437
62207-753-44Naproxen Sodium150 in 1 BOTTLETABLET1507
62207-753-45Naproxen Sodium200 in 1 BOTTLETABLET2007
62207-753-47Naproxen Sodium500 in 1 BOTTLETABLET5007
62207-753-49Naproxen Sodium1000 in 1 BOTTLETABLET10007
62207-753-51Naproxen Sodium10 in 1 BOTTLETABLET107
62207-753-52Naproxen Sodium300 in 1 BOTTLETABLET3007
62207-753-53Naproxen Sodium400 in 1 BOTTLETABLET4007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-750NAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]7Legacy NDC, 10 package rows20231213_28d602d3-7f53-4575-848d-0670ea557d2a.zip
62207-753NAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]7Legacy NDC, 10 package rows20231213_28d602d3-7f53-4575-848d-0670ea557d2a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3C2
NAPROXENACTIVE MOIETY57Y76R9ATQ2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
POVIDONE K30INACTIVE INGREDIENTU725QWY32X2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

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 4 · 230 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
36 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGEL / RECTAL348 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, CHEWABLE / ORAL245 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / SUBLINGUAL30 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, DELAYED RELEASE PARTICLES / ORAL70 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XFILM, EXTENDED RELEASE / TRANSDERMAL16 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XINSERT / VAGINAL147 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, COATED / ORAL24.12 mgExact identifier — unii candidate
11 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XLOZENGE / ORAL700 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION/ DROPS / OPHTHALMIC1 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 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
A091353-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-09-20

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 22:38:342026-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2084e616aacf4f…
2026-08-18 06:07:402026-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091353-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091353-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20f41ea6bd6efb…

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
0c3a7f55-1cf1-e6bf-e063-6294a90afccb28d602d3-7f53-4575-848d-0670ea557d2a2023-12-11WarningsExact identifier
spl id: 0c3a7f55-1cf1-e6bf-e063-6294a90afccb
spl set id: 28d602d3-7f53-4575-848d-0670ea557d2a

Reported adverse events (FAERS/openFDA)#

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