What this pack is
Aldactone is the brand name in this record; spironolactone is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
AldactoneGeneric namespironolactone
How this medicine works
The U.S. ALDACTONE label describes spironolactone as an aldosterone antagonist acting at the distal renal tubule. This mechanism helps read the drug class and label warnings; it does not predict an individual's fluid change, blood pressure, potassium, suitability, tablet count or any combination plan.
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
- Aldactone
- Generic name
- spironolactone
- Dosage-form class
- Oral film-coated tablets: 25 mg, 50 mg and 100 mg (as listed in the current U.S. 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.
3 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 SPL v25, published 1 Dec 2025
25 mg per tablet; 100-tablet bottle
- Product code
- NDC 0025-1001-31
- Form and route
- ALDACTONE spironolactone film-coated oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- spironolactone
- 25 mglabelled amount per tablet; not an individual's tablet count, diuretic or potassium plan
- Package
- 100 tablets per bottle
United States label · DailyMed SPL v25, published 1 Dec 2025
50 mg per tablet; 100-tablet bottle
- Product code
- NDC 0025-1041-31
- Form and route
- ALDACTONE spironolactone film-coated oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- spironolactone
- 50 mglabelled amount per tablet; not an individual's tablet count, diuretic or potassium plan
- Package
- 100 tablets per bottle
United States label · DailyMed SPL v25, published 1 Dec 2025
100 mg per tablet; 100-tablet bottle
- Product code
- NDC 0025-1031-31
- Form and route
- ALDACTONE spironolactone film-coated oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-04; actual marketing, stock and availability are not established.
- spironolactone
- 100 mglabelled amount per tablet; not an individual's tablet count, diuretic or potassium plan
- Package
- 100 tablets per bottle
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
ALDACTONE label reading: 25, 50 and 100 mg identify each tablet; they are not a diuretic or potassium plan
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 the current U.S. DailyMed public label to check ALDACTONE, spironolactone, 25/50/100 mg per tablet, film-coated oral tablets and the exact bottle. It does not decide an individual's tablet count, potassium monitoring, diet, supplements, diuretic plan or combination with another cardiovascular product.
- Check ALDACTONE, spironolactone, 25, 50 or 100 mg per tablet, oral-tablet form, actual NDC and target market together. Milligrams are the labelled amount in an exact tablet, not a web rule for personal tablet count, alternate-day use or replacing one pack with another.
- The label includes warnings about hyperkalaemia, worsening renal function, hypotension and electrolyte abnormalities, and flags potassium supplements, high-potassium foods and salt substitutes for review. These do not let a website decide whether an individual should use or avoid a product; take the packs, supplements, OTC products and complete medicine list to a pharmacist or clinician.
- “Diuretic”, “aldosterone antagonist” and “potassium-sparing” are class clues; they do not permit self-combining, alternating or replacing ALDACTONE with another diuretic, blood-pressure medicine, heart-failure medicine, potassium product or herb. Strength, dosage form, target-market label, prior reactions and test results all need review together.
- The label identifies other potassium-raising products, NSAIDs (common in pain or fever medicines) and lithium as co-medication clues requiring professional review. NSAIDs may reduce diuretic, natriuretic or antihypertensive effects, while diuretics may reduce lithium clearance and increase lithium-toxicity risk. When these names appear, the complete medicine list, kidney function and relevant tests need review rather than self-separating timing, stopping or changing an amount.
- The current U.S. label lists inactive ingredients including calcium sulfate, corn starch, flavour, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. This excipient list applies only to the exact U.S. label and can frame allergy or tolerability questions for a pharmacist; it does not prove another manufacturer is inferior, has different efficacy or can be self-substituted.
- With fainting, marked palpitations or weakness, breathing difficulty, severe vomiting or diarrhoea, altered consciousness or another acute severe problem, prioritise local emergency medical support; do not wait for a website search or self-counteract or adjust with another 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 · 2026-08-20
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): current U.S. ALDACTONE spironolactone public label (Pfizer; SPL v25, published 1 Dec 2025) ↗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.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-04DailyMed (NLM): current U.S. ALDACTONE electronic label PDF (enlargeable) ↗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 Aldactone (spironolactone). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Aldactone is the brand in this record and spironolactone is the active-ingredient name. Check both with the dosage form (Oral film-coated tablets: 25 mg, 50 mg and 100 mg (as listed in the current U.S. 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): current U.S. ALDACTONE spironolactone public label (Pfizer; SPL v25, published 1 Dec 2025) ↗reviewed 2026-08-20
- DailyMed (NLM): current U.S. ALDACTONE electronic label PDF (enlargeable) ↗Current regulatory record · reviewed 2026-09-04
CO-MEDICATION REVIEW · NOT A TREATMENT DECISION
When KLOR-CON / potassium chloride is on the same list: review potassium, kidney function and the complete medicine list first
The U.S. public ALDACTONE label says co-use with potassium supplementation or other medicines that can increase potassium may lead to hyperkalaemia, with greater risk in renal impairment. This card only signals that ALDACTONE, KLOR-CON, other prescription medicines, OTC products, supplements, salt substitutes and relevant tests need review by a pharmacist or prescribing team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine.
Open the KLOR-CON / potassium chloride extended-release tablets record →
Add both records to this device's family medicine list →
Open the primary source for this co-medication review cue ↗reviewed 2026-08-20HOW IT WORKS · NOT A TREATMENT PLAN
How spironolactone works: it blocks an aldosterone pathway
- “Blocking aldosterone” explains one physiologic pathway; it is not a website tool for determining the cause of oedema, blood pressure, fatigue, palpitations or an abnormal test. Need for treatment or adjustment requires a professional with the exact diagnosis, tests and complete medicine list.
- Neither the mechanism nor the phrase “potassium-sparing” replaces individual review of kidney function, electrolytes, other cardiovascular medicines, pain medicines, supplements or salt substitutes. Do not self-add, remove or make up any medicine or supplement from a mechanism word.
- When another product affects fluid balance, blood pressure or kidney-related pathways, neither a different class nor a different mechanism proves it can be combined. Bringing the complete medicine list and actual packs to a pharmacist or clinician is the next step.
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): current U.S. ALDACTONE spironolactone public label (Pfizer; SPL v25, published 1 Dec 2025) ↗reviewed 2026-08-20
- DailyMed (NLM): current U.S. ALDACTONE electronic label PDF (enlargeable) ↗Current regulatory record · reviewed 2026-09-04
- FDA: ALDACTONE (spironolactone) tablets NDA 012151/S-080 supplemental approval letter (19 Nov 2025) ↗reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Aldactonespironolactone
This page includes an exact current U.S. public-label package panel for Aldactone, 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
Initial U.S. approval year listed in the current label
The current ALDACTONE label lists Initial U.S. Approval: 1960; it does not establish product status in another market.
DailyMed (NLM): current U.S. ALDACTONE spironolactone public label (Pfizer; SPL v25, published 1 Dec 2025) ↗NDA 012151 S-080 supplemental approval
The FDA public approval letter records approval of NDA 012151/S-080 for ALDACTONE (spironolactone) tablets on 19 Nov 2025. This regulatory node does not establish individual suitability, combination, adjustment or another-market status.
FDA: ALDACTONE (spironolactone) tablets NDA 012151/S-080 supplemental approval letter (19 Nov 2025) ↗Current SPL v25 published on DailyMed
DailyMed lists 1 Dec 2025 as the Published Date for the current ALDACTONE SPL v25. The public date, label image and NDC record identity only; they do not establish individual use, stock, availability or interchangeability.
DailyMed (NLM): current U.S. ALDACTONE spironolactone public label (Pfizer; SPL v25, published 1 Dec 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Current label and three exact bottle panels linkedThis page records the specified NDC and 100-tablet bottle panel separately for 25 mg, 50 mg and 100 mg; it does not establish actual marketing, stock, individual use, potassium management, combination, switching or another-presentation status.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, packaging, supply, originator relationship or interchangeability is inferred from the U.S. label.
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
Can 25, 50 and 100 mg be self-converted into tablet counts or another bottle?
No. They are distinct tablet identities listed in the current label. This page does not turn package numbers into an individual's tablet count, alternate-day use, potassium plan, combination, substitution or adjustment rule; take the actual pack and complete medicine list to a pharmacist or clinician.
Does “potassium-sparing” mean a person can self-add or remove potassium products, salt substitutes or another medicine?
No. It is a mechanism and class clue, not an individual combination conclusion. Kidney function, electrolytes, prior reactions, other medicines and the exact label all require joint professional 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.