What this pack is
VOLTAREN-XR is the brand name in this record; diclofenac sodium extended-release tablets is the generic name. Read both together with the dosage form (ophthalmic product).
PACK CHECK · MARKET FIRST
VOLTAREN-XRGeneric namediclofenac sodium extended-release tablets
How this medicine works
The label explains that diclofenac inhibits COX-1 and COX-2 and reduces prostaglandin synthesis, producing analgesic, anti-inflammatory and antipyretic effects. The shared mechanism also explains why gastrointestinal, cardiovascular, renal, bleeding, oedema and duplicate-NSAID risks require review, but it cannot determine an individual dose or switch.
Read source: United States ↗reviewed 2026-09-02More 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
- VOLTAREN-XR
- Source-scoped market brand names
- VOLTAREN-XR · United StatesHistorical regulator record ↗NDA 020254, 100 mg extended-release tablet, historical RLD and currently DISCN; this does not establish current brand supply.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- diclofenac sodium extended-release tablets
- Dosage-form class
- Diclofenac sodium 100 mg extended-release oral tablets. VOLTAREN diclofenac sodium delayed-release tablets, CATAFLAM diclofenac potassium immediate-release tablets, topical gel and ophthalmic solution are separate exact products. The label states that different oral formulations are not necessarily bioequivalent even at the same milligram strength.
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
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 · Dated Apr 2021 FDA VOLTAREN-XR brand label (historical archive)
Diclofenac sodium 100 mg per tablet; 100-tablet bottle; historical RLD, currently DISCN
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 0078-0446-05
- Form and route
- VOLTAREN-XR diclofenac sodium 100 mg extended-release oral tablet (historical brand) · oral
- Container
- historical 100-tablet bottle
- Listing review
- Cited product evidence reviewed 2026-09-02; actual marketing, stock and availability are not established.
- diclofenac sodium
- 100 mgper-tablet amount in the historical brand label; not current supply or an individual tablet count
- Package
- 100 tablets per bottle
- Labelled appearance
- light pink · round, biconvex, bevel-edged film-coated tablet; text-only appearance from the 2021 historical label · imprint Voltaren-XR / 100Historical source text describes an unscored presentation
United States label · Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)
Diclofenac sodium 100 mg per tablet; 30-tablet bottle
- Product code
- NDC 80425-0414-01
- Form and route
- diclofenac sodium 100 mg extended-release oral tablet (generic comparator) · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- diclofenac sodium
- 100 mglabelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products
- Package
- 30 tablets per bottle
- Labelled appearance
- pink · round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split · imprint ING / 278Unscored; do not infer splitting permission
United States label · Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)
Diclofenac sodium 100 mg per tablet; 60-tablet bottle
- Product code
- NDC 80425-0414-02
- Form and route
- diclofenac sodium 100 mg extended-release oral tablet (generic comparator) · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- diclofenac sodium
- 100 mglabelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products
- Package
- 60 tablets per bottle
- Labelled appearance
- pink · round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split · imprint ING / 278Unscored; do not infer splitting permission
United States label · Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)
Diclofenac sodium 100 mg per tablet; 90-tablet bottle
- Product code
- NDC 80425-0414-03
- Form and route
- diclofenac sodium 100 mg extended-release oral tablet (generic comparator) · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- diclofenac sodium
- 100 mglabelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products
- Package
- 90 tablets per bottle
- Labelled appearance
- pink · round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split · imprint ING / 278Unscored; do not infer splitting permission
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
VOLTAREN-XR enlarged label: separate salt, release design, mg per tablet and duplicate NSAIDs
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.
The 100 mg figure is labelled diclofenac sodium per tablet, while 30/60/90/100 Tablets are different bottle counts—not an individual tablet count. Brand extended-release, sodium delayed-release and potassium immediate-release tablets are not automatically equivalent at the same milligram number.
- The current generic comparator is a pink, round, unscored extended-release tablet. Neither the unscored appearance nor the extended-release wording is web permission to cut, crush, powder or replace another strength with half a tablet; check the exact product, prescription and current label in hand.
- Do not self-combine it with NAPROSYN, ALEVE, ADVIL, MOBIC, CELEBREX, ARCOXIA, analgesic-dose aspirin or another NSAID. Different brand names may still share class risks; the site does not generate separation or substitution plans.
- Older adults; people with prior ulcer or bleeding, cardiovascular disease, heart failure, oedema, hepatic or renal impairment; and those co-using anticoagulant/antiplatelet medicines, corticosteroids, an SSRI/SNRI, ACE inhibitor/ARB, diuretic, lithium, methotrexate or ciclosporin require priority pharmacist or clinical review.
- Chest pain, one-sided weakness or slurred speech, breathing difficulty, face/throat swelling, vomiting blood, black stool, severe rash with fever or another severe acute feature requires immediate local emergency care; take every medicine pack.
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 · 2026-09-02
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 · 3
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. generic label, Medication Guide and three exact bottle panels for diclofenac sodium 100 mg extended-release tablets (published 16 Jul 2024) ↗Current regulatory record · reviewed 2026-09-02
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-09-02FDA: dated VOLTAREN-XR diclofenac sodium 100 mg extended-release tablet brand label (revised Apr 2021; historical label, not evidence of current brand supply) ↗reviewed 2026-09-02
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book: historical RLD product records for VOLTAREN, VOLTAREN-XR and CATAFLAM (data retrieved 26 Aug 2026) ↗reviewed 2026-08-29
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 VOLTAREN-XR (diclofenac sodium extended-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
VOLTAREN-XR is the brand in this record and diclofenac sodium extended-release tablets is the active-ingredient name. Check both with the dosage form (Diclofenac sodium 100 mg extended-release oral tablets. VOLTAREN diclofenac sodium delayed-release tablets, CATAFLAM diclofenac potassium immediate-release tablets, topical gel and ophthalmic solution are separate exact products. The label states that different oral formulations are not necessarily bioequivalent even at the same milligram strength.) 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): current U.S. generic label, Medication Guide and three exact bottle panels for diclofenac sodium 100 mg extended-release tablets (published 16 Jul 2024) ↗Current regulatory record · reviewed 2026-09-02
- FDA: dated VOLTAREN-XR diclofenac sodium 100 mg extended-release tablet brand label (revised Apr 2021; historical label, not evidence of current brand supply) ↗reviewed 2026-09-02
- FDA Orange Book: historical RLD product records for VOLTAREN, VOLTAREN-XR and CATAFLAM (data retrieved 26 Aug 2026) ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How diclofenac works: COX-1/COX-2 inhibition reduces prostaglandin formation
- VOLTAREN-XR, VOLTAREN delayed-release tablets and CATAFLAM immediate-release diclofenac potassium share diclofenac-related ingredients but differ in salt or release design; the label says they are not necessarily bioequivalent even at the same milligram strength.
- Topical VOLTAREN Arthritis Pain gel and ophthalmic VOLTAREN are different-route products; topical percentage, oral milligrams and ophthalmic concentration do not belong in one conversion table.
- Mechanism cannot answer how many tablets an individual should take. If several pain or anti-inflammatory products appear across packs, prescriptions or the medicine list, do not self-add another product; have a pharmacist review exact ingredients, dosage forms and brands.
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.
- FDA: dated VOLTAREN-XR diclofenac sodium 100 mg extended-release tablet brand label (revised Apr 2021; historical label, not evidence of current brand supply) ↗reviewed 2026-09-02
- FDA: VOLTAREN-XR NDA 020254/S-030 supplemental safety-labelling approval letter (2021) ↗reviewed 2026-09-02
- FDA Orange Book: historical RLD product records for VOLTAREN, VOLTAREN-XR and CATAFLAM (data retrieved 26 Aug 2026) ↗reviewed 2026-08-29
- DailyMed (NLM): current U.S. generic label, Medication Guide and three exact bottle panels for diclofenac sodium 100 mg extended-release tablets (published 16 Jul 2024) ↗Current regulatory record · reviewed 2026-09-02
SOURCE-TRACEABLE ARCHIVE
VOLTAREN-XRdiclofenac sodium extended-release tablets
This page includes an exact current U.S. public-label package panel for VOLTAREN-XR, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approved VOLTAREN-XR 100 mg extended-release tablets
Current Orange Book data connect NDA 020254, 100 mg, historical RLD status and this date; the current product status is DISCN.
FDA Orange Book: historical RLD product records for VOLTAREN, VOLTAREN-XR and CATAFLAM (data retrieved 26 Aug 2026) ↗FDA approved a supplemental safety-labelling revision
The revision addressed NSAID safety information including fetal renal dysfunction, oligohydramnios, neonatal renal impairment and DRESS.
FDA: VOLTAREN-XR NDA 020254/S-030 supplemental safety-labelling approval letter (2021) ↗Current generic DailyMed label published
The label lists 100 mg extended-release tablets, the ING/278 appearance and exact 30/60/90-tablet bottle panels.
DailyMed (NLM): current U.S. generic label, Medication Guide and three exact bottle panels for diclofenac sodium 100 mg extended-release tablets (published 16 Jul 2024) ↗
MARKET SCOPE
Market-record boundary
United States
Historical VOLTAREN-XR RLD currently DISCN; current generic label listed separatelyHistorical brand record, current generic listing and live pharmacy stock are separate evidence layers.
Markets outside the United States
Local approval, brand, dosage form, package and supply are not established by this dossierCheck the local regulator and current local label market by market. Historical U.S. brand and current U.S. generic evidence must not be projected as worldwide status.
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 VOLTAREN-XR 100 mg and 100 mg diclofenac sodium delayed-release tablets the same?
No such conclusion follows. Extended-release, delayed-release and immediate-release tablets have different release designs, and the label states that different oral diclofenac formulations are not necessarily bioequivalent even at the same milligram strength. Do not self-convert, assemble tablets or substitute.
Is the pink ING/278 tablet on this page originator VOLTAREN-XR?
No. The image comes from the current ANDA 216275 generic label. Historical VOLTAREN-XR retains only the FDA label's text identity; the site does not reuse a generic image as the originator brand.
Can diclofenac be added if ibuprofen, naproxen, celecoxib or aspirin is already being used?
Do not self-combine them. These medicines may share NSAID, bleeding, gastrointestinal, cardiovascular or renal risks. Give all prescriptions, OTC pain medicines, cold 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.