What this pack is
Bactrim is the brand name in this record; sulfamethoxazole and trimethoprim is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
BactrimGeneric namesulfamethoxazole and trimethoprim
How this medicine works
The BACTRIM DailyMed label explains that sulfamethoxazole competes with para-aminobenzoic acid to inhibit bacterial dihydrofolic-acid synthesis, while trimethoprim reversibly inhibits dihydrofolate reductase and blocks tetrahydrofolic-acid formation. They act at consecutive steps in nucleic-acid and protein biosynthesis in many bacteria. This overview does not diagnose an infection or decide whether an individual needs an antibacterial, which product to use, strength, tablet count or course.
Read source: United States ↗reviewed 2026-08-20More 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
- Bactrim
- Generic name
- sulfamethoxazole and trimethoprim
- Dosage-form class
- Oral tablets: BACTRIM 400 mg/80 mg; BACTRIM DS 800 mg/160 mg(as listed in the 2024-12 DailyMed public label)
- 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.
1 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 · DailyMed public label, updated 30 Dec 2024; cited label panel only, not availability
Sulfamethoxazole 800 mg / trimethoprim 160 mg per tablet; 100-tablet bottle
- Product code
- NDC 49708-146-01
- Form and route
- BACTRIM DS sulfamethoxazole/trimethoprim oral tablet · oral
- Container
- bottle
- Listing review
- Cited public label display reviewed 2026-08-21; actual marketing, stock and availability are not established.
- sulfamethoxazole
- 800 mglabelled amount per tablet; check together with trimethoprim, not an individual tablet count, course or self-conversion
- trimethoprim
- 160 mglabelled amount per tablet; check together with sulfamethoxazole, not an individual tablet count, course or self-conversion
- Package
- 100 tablets per bottle
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
BACTRIM label reading: 400/80 and DS 800/160 require joint checks of two ingredients, strength and pack
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.
This module uses Sun Pharmaceutical Industries, Inc.'s Dec 2024 U.S. DailyMed public label as a reading entry point. It distinguishes BACTRIM 400 mg sulfamethoxazole/80 mg trimethoprim tablets from BACTRIM DS 800 mg/160 mg tablets. The visual is limited to the DS 800 mg/160 mg, 100-tablet bottle (NDC 49708-146-01); it does not provide an individual's tablet count, course, make-up, switching or combination plan with another anti-infective.
- “400 mg/80 mg” and “800 mg/160 mg” each label two active ingredients, not one number to self-add, split or convert. DS (double strength) is an identity term for the exact pack; the shared name or doubled numbers do not permit self-substitution, combining or make-up use between regular and DS tablets.
- The pictured NDC 49708-146-01, 100-tablet count and “BACTRIM DS 800 mg/160 mg” are combined clues for one U.S. bottle. Pack count is not a course length, and appearance cannot authenticate a medicine or establish that another pack, market or dosage form is the same.
- This page covers oral tablets; it does not cover BACTRIM's historical intravenous label or another sulfamethoxazole/trimethoprim product. Even with the same generic names, an oral-tablet page cannot derive infusion, conversion, division or another route of administration.
- The label includes warnings related to serious skin reactions, blood, kidney, potassium and multiple co-medications. With an anticoagulant, glucose-lowering medicine, diuretic/blood-pressure medicine, methotrexate, supplement or multiple medicines, or with widespread rash, mouth/eye mucosal problems, fever, marked weakness or another severe concern, use timely local medical support and have professionals review the complete list; do not self-repeat, combine, stop/switch or share an antibacterial.
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 · 2026-08-20
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 · 2
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): BACTRIM / BACTRIM DS public label (Sun Pharmaceutical Industries, Inc., 2024-12 updated) ↗reviewed 2026-08-20
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 · 2026-08-20FDA: BACTRIM 2020 U.S.intravenous injectionhistoricallabel (NDA 018374; not equivalent tothis pageoral package) ↗Historical public record · reviewed 2026-08-20
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA FAERS record: labelling-update information for sulfamethoxazole/trimethoprim2023-09-30 · FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Bactrim, Bactrim DS and related sulfamethoxazole/trimethoprim products and states that Warnings and Precautions and Adverse Reactions were updated in February 2025 with hemophagocytic lymphohistiocytosis (HLH) information. It is a regulatory safety-signal and labelling-update record, not a way to determine an individual event or self-stop/switch treatment.Primary-source record (open linked document) ↗reviewed 2026-08-22
- FDA-hosted company recall announcement: specific Amneal sulfamethoxazole/trimethoprim tablets2025-06-04 · FDA explicitly says this is a company announcement it posts as a public service and does not endorse the company or product. The announcement concerns only U.S. Amneal sulfamethoxazole/trimethoprim 400 mg/80 mg tablets, three named lots (AM241019, AM241019A, AM241020), and the listed NDCs/packs. It does not apply to Bactrim brand, Bactrim DS, 800 mg/160 mg, another manufacturer, another lot, another market, or any current-product-status conclusion.Primary-source record (open linked document) ↗reviewed 2026-08-22
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 Bactrim (sulfamethoxazole and trimethoprim). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Bactrim is the brand in this record and sulfamethoxazole and trimethoprim is the active-ingredient name. Check both with the dosage form (Oral tablets: BACTRIM 400 mg/80 mg; BACTRIM DS 800 mg/160 mg(as listed in the 2024-12 DailyMed public label)) 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): BACTRIM / BACTRIM DS public label (Sun Pharmaceutical Industries, Inc., 2024-12 updated) ↗reviewed 2026-08-20
- FDA: BACTRIM 2020 U.S.intravenous injectionhistoricallabel (NDA 018374; not equivalent tothis pageoral package) ↗Historical public record · reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How sulfamethoxazole/trimethoprim works: two ingredients block consecutive steps in bacterial folate synthesis
- “Two-step folate-pathway blockade” is a pharmacology concept explaining why two ingredients appear on one label. It does not mean every fever, cough, diarrhoea, urinary symptom, rash or other symptom is bacterial or suitable for this product. Cause, testing when relevant, market label and professional assessment must be checked separately.
- A related or different pathway with another antibacterial, or a name containing “sulfa” or “trimethoprim,” does not permit self-combination, alternation, milligram conversion or use of leftovers. The exact product, infection assessment, kidney-related context, complete medicine list and current label need item-by-item professional review.
- Mechanism does not remove the possibility of serious skin reactions, blood, kidney, potassium or interaction risks, and it cannot decide abrupt self-stopping. With widespread rash, mucosal abnormality, breathing difficulty, fainting, marked weakness or another acute serious concern, prioritise local medical support.
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): BACTRIM / BACTRIM DS public label (Sun Pharmaceutical Industries, Inc., 2024-12 updated) ↗reviewed 2026-08-20
- FDA: BACTRIM 2020 U.S.intravenous injectionhistoricallabel (NDA 018374; not equivalent tothis pageoral package) ↗Historical public record · reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Bactrimsulfamethoxazole and trimethoprim
This page links to public primary-source material for Bactrim. 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
FDA label archive version
This page links the 2024-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document.
DailyMed: BACTRIM / BACTRIM DS public label archive ↗
MARKET SCOPE
Market-record boundary
United States
Public label archive linkedOnly the FDA document listed on this page is linked.
Mainland China, EU, Japan
Market record not establishedNo local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive.
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
Does a label archive represent current product information?
Not automatically. The archive locates a source; each point needs verification against the target market’s current official label.
Why are price and originator/generic conclusions not shown?
Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient.
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.