What this pack is
NAPROSYN is the brand name in this record; naproxen and naproxen sodium tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
NAPROSYNGeneric namenaproxen and naproxen sodium tablets
How this medicine works
The label states that the mechanism is not fully understood but involves inhibition of cyclooxygenase COX-1 and COX-2 and reduced prostaglandin synthesis in peripheral tissues. Prostaglandins participate in pain and inflammation as well as gastrointestinal, kidney, platelet and pregnancy-related physiology, so analgesic action cannot be separated from risk reading.
Read source: United States ↗Current regulatory record · reviewed 2026-09-04More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- NAPROSYN
- Generic name
- naproxen and naproxen sodium tablets
- Dosage-form class
- Oral tablets: NAPROSYN 500 mg is a conventional naproxen tablet; EC-NAPROSYN 375 mg and 500 mg are delayed-release enteric-coated tablets whose coating must remain intact; ANAPROX DS 550 mg is a naproxen sodium tablet labelled as equivalent to naproxen 500 mg and containing 50 mg sodium. Package numbers do not permit self-interchange, combination or tablet splitting.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
4 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)
naproxen 500 mg per tablet; 100-tablet bottle; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 69437-316-01
- Form and route
- NAPROSYN naproxen conventional oral tablet · oral (exact-product identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- naproxen
- 500 mglabelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- yellow · capsule-shaped with a score on one side; the score is only an exact-product appearance clue · imprint NPR / LE / 500Scored appearance; this is not permission to split it yourself
United States label · Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)
naproxen 375 mg per tablet; 100-tablet bottle; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 69437-415-01
- Form and route
- EC-NAPROSYN naproxen delayed-release oral tablet · oral (exact-product identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- naproxen
- 375 mglabelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- white · oval biconvex coated tablet without a score; do not break, crush or chew · imprint NPR / EC / 375Unscored delayed-release presentation; do not break, crush or chew it
United States label · Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)
naproxen 500 mg per tablet; 100-tablet bottle; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 69437-416-01
- Form and route
- EC-NAPROSYN naproxen delayed-release oral tablet · oral (exact-product identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- naproxen
- 500 mglabelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- white · oblong coated tablet without a score; do not break, crush or chew · imprint NPR / EC / 500Unscored delayed-release presentation; do not break, crush or chew it
United States label · Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)
naproxen sodium 550 mg per tablet, equivalent to naproxen 500 mg; 100-tablet bottle; not an individual's tablet count
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 69437-203-01
- Form and route
- ANAPROX DS naproxen sodium conventional oral tablet · oral (exact-product identity field)
- Container
- plastic bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- naproxen sodium
- 550 mglabelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- dark blue · oblong with scores on both sides; the score is only an exact-product appearance clue · imprint NPS / 550Scored appearance; this is not permission to split it yourself
PACKAGE-VISUAL STATUS
Four package identities have source text, but their image endpoints currently return empty responses
The DailyMed label page lists four 100-tablet identities for NAPROSYN 500 mg, EC-NAPROSYN 375/500 mg and ANAPROX DS 550 mg with corresponding image filenames. On individual checks dated 4 Sep 2026, every image endpoint returned HTTP 200 but a zero-byte text/html body. The site therefore withholds these images and does not substitute screenshots, retail images or look-alike tablets. Brand, dosage form, strength, NDC, imprint and source link remain separated for all four products.
LABEL READING · NOT A PRESCRIPTION
NAPROSYN enlarged label: prevent duplicate NSAIDs, then review gastrointestinal, cardiovascular, kidney and oedema risks
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Black stools, vomiting blood, chest pain, shortness of breath, one-sided weakness or speech difficulty, face or throat swelling, markedly reduced urine, rapid swelling, blistering or skin erosion are not situations for continued self-trial from a webpage and require timely local medical support. Older adults and people with prior ulcer or bleeding, kidney disease, heart failure, dehydration or multiple medicines need priority full-list review.
- NAPROSYN, EC-NAPROSYN, ANAPROX DS, ALEVE and other naproxen products share the naproxen active moiety; the label says naproxen-containing products should not be used together. Other NSAIDs such as ibuprofen, diclofenac, celecoxib, etoricoxib or analgesic-dose aspirin must not be self-combined by brand name.
- EC-NAPROSYN is a delayed-release enteric-coated tablet whose coating must remain intact; do not break, crush or chew it. Scores on NAPROSYN and ANAPROX DS identify the exact product. Any splitting still belongs to the exact prescription and product review, not general permission from this site.
- Warfarin, aspirin, clopidogrel and other medicines affecting haemostasis, SSRI/SNRI antidepressants, ACE inhibitors/ARBs, diuretics, digoxin, lithium, methotrexate, ciclosporin and other NSAIDs require review against the complete medicine list. The site does not generate a separation or stopping plan.
- NAPROSYN 500 mg, EC-NAPROSYN 500 mg and ANAPROX DS 550 mg are all naproxen-related but do not share the same release pattern or chemical form. Different formulations and strengths are not self-interchangeable from milligram numbers.
- Older adults have higher risk of serious NSAID-associated gastrointestinal, cardiovascular and kidney reactions. Prescriptions, OTC pain or cold products, aspirin and supplements should be reviewed together by a pharmacist.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-04
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. public label, Medication Guide and four exact package panels for NAPROSYN / EC-NAPROSYN / ANAPROX DS (updated 3 Jan 2025; prescribing information revised Nov 2024) ↗Current regulatory record · reviewed 2026-09-04
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about NAPROSYN (naproxen and naproxen sodium tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
NAPROSYN is the brand in this record and naproxen and naproxen sodium tablets is the active-ingredient name. Check both with the dosage form (Oral tablets: NAPROSYN 500 mg is a conventional naproxen tablet; EC-NAPROSYN 375 mg and 500 mg are delayed-release enteric-coated tablets whose coating must remain intact; ANAPROX DS 550 mg is a naproxen sodium tablet labelled as equivalent to naproxen 500 mg and containing 50 mg sodium. Package numbers do not permit self-interchange, combination or tablet splitting.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): FDA-approved NSAID Medication Guide for NAPROSYN / EC-NAPROSYN / ANAPROX DS ↗Current regulatory record · reviewed 2026-09-04
- DailyMed (NLM): current U.S. public label, Medication Guide and four exact package panels for NAPROSYN / EC-NAPROSYN / ANAPROX DS (updated 3 Jan 2025; prescribing information revised Nov 2024) ↗Current regulatory record · reviewed 2026-09-04
HOW IT WORKS · NOT A TREATMENT PLAN
How naproxen works: inhibition of COX-1/COX-2 and prostaglandin synthesis
- The sodium-salt design of ANAPROX DS is absorbed more rapidly, while the enteric design of EC-NAPROSYN delays absorption. Different absorption patterns are one reason similar milligram numbers do not permit self-substitution.
- The COX/prostaglandin mechanism cannot determine which NSAID an individual should use, a tablet count, or whether aspirin can be co-used.
- Membership in the NSAID class does not permit rotation or combination. The shared mechanism instead signals the need to check duplication and gastrointestinal, cardiovascular and kidney risks first.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): FDA-approved NSAID Medication Guide for NAPROSYN / EC-NAPROSYN / ANAPROX DS ↗Current regulatory record · reviewed 2026-09-04
- DailyMed (NLM): current U.S. public label, Medication Guide and four exact package panels for NAPROSYN / EC-NAPROSYN / ANAPROX DS (updated 3 Jan 2025; prescribing information revised Nov 2024) ↗Current regulatory record · reviewed 2026-09-04
- FDA: 2024 supplemental approval letter for NAPROSYN NDA 017581, ANAPROX DS NDA 018164 and EC-NAPROSYN NDA 020067 ↗reviewed 2026-09-04
SOURCE-TRACEABLE ARCHIVE
NAPROSYNnaproxen and naproxen sodium tablets
This page links to public primary-source material for NAPROSYN. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year listed in the label
The current DailyMed label lists Initial U.S. Approval: 1976. This only locates U.S. brand history and is not extrapolated to another market.
DailyMed (NLM): current U.S. public label, Medication Guide and four exact package panels for NAPROSYN / EC-NAPROSYN / ANAPROX DS (updated 3 Jan 2025; prescribing information revised Nov 2024) ↗FDA approved safety-labelling supplements for three NDAs
The approval letter identifies NDA 017581/S-117, 018164/S-067 and 020067/S-026 and encloses revised prescribing information and Medication Guide.
FDA: 2024 supplemental approval letter for NAPROSYN NDA 017581, ANAPROX DS NDA 018164 and EC-NAPROSYN NDA 020067 ↗Current DailyMed public-label page updated
The page lists four exact NDCs, labelled amounts per tablet, appearance, package panels and the Nov 2024 revised label.
DailyMed (NLM): current U.S. public label, Medication Guide and four exact package panels for NAPROSYN / EC-NAPROSYN / ANAPROX DS (updated 3 Jan 2025; prescribing information revised Nov 2024) ↗
MARKET SCOPE
Market-record boundary
United States
Current public label and four exact NDC/package panels linkedA public regulatory record does not establish current stock, purchase channel, authenticity or individual suitability.
Mainland China, EU, Japan and other markets
Current local market record not yet establishedNo local approval, brand, supply, originator/generic relationship or interchangeability is inferred from a U.S. NDA, NDC, English brand or package image.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Are NAPROSYN 500 mg and ANAPROX DS 550 mg the same product?
They are not the same exact product. The first contains naproxen 500 mg per tablet; the second contains naproxen sodium 550 mg, labelled as equivalent to naproxen 500 mg and containing 50 mg sodium. A shared active moiety does not permit self-conversion, substitution, combination or tablet-count selection.
Can EC-NAPROSYN be split or crushed?
No. The current label requires the enteric coating to remain intact and says not to break, crush or chew the tablet. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber rather than altering the dosage form.
Can NAPROSYN be added if ALEVE, ibuprofen or aspirin is already being used?
Do not self-combine them. ALEVE may already contain naproxen sodium; ibuprofen and aspirin are also priority NSAID/haemostasis review medicines. Give all prescriptions, OTC products, cold/pain combinations and supplements to a pharmacist for exact-product review.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.