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Podocon 25 Podophyllum resin 1 mg/4mL Tincture — NDC 00574-0601-15 package photo

Podocon 25 Podophyllum resin 1 mg/4mL Tincture

by Padagis US LLC · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0574-0601-15) / 15 mL in 1 BOTTLE, WITH APPLICATOR
NDC 00574-0601-15
🏷️ FDA NDC (as labeled) 0574-0601-15 billing pads the labeler segment with a zero
Rx only On market Non-controlled ⚠ On shortage
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Active FDA shortage. Podophyllum Resin Topical Tincture is currently reported in shortage by the FDA. Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 0574-0601-15
Product NDC 0574-0601
11-digit billing NDC 00574060115
NCPDP billing unit ML — per mL (volume)
UNII 16902YVY2B
SPL Set ID de96dc6e-e6d1-4383-9ce1-4d06bac08e00
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-01
Route TOPICAL
Dosage form TINCTURE
Substance PODOPHYLLUM RESIN
GPI-14 90750020002025
GPI class Podocon-25
GCN Seq No 005795
GCN 22850
HICL code 002466
Ingredient (HICL) Podophyllum Resin
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name PODOCON-25 LIQUID
FDB brand name Podocon-25
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0574-0601-15 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00574-0601-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerPadagis US LLC
Labeler code00574
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio63 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PODOCON-25 LIQUID Ingredient Podophyllum Resin
🧪 What is this product?

Podocon 25 is a topical tincture containing podophyllum resin, a plant-derived substance. Podophyllum resin is typically used in dermatology as a topical agent for removal of certain skin growths, particularly warts and similar lesions. This product is an unapproved drug and is not marketed under an FDA-approved application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII FE663Z8IRO
    A resinous gum extracted from the styrax tree, used as a preservative and binder in medicines. It helps prevent spoilage and holds ingredients together in solid formulations.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Podocon 25 1 mg/4mL 63629-8699-01 Bryant 1 bottle — — FDA listed —
Podocon 25 1 mg/4mL 72162-1117-02 Bryant 1 bottle — — FDA listed —
Podocon 25 1 mg/4mLthis 00574-0601-15 Padagis 1 bottle — — FDA listed —
Podocon 25 1 mg/4mL 71335-2925-01 Bryant 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Podocon 25 (this brand).

Top reported reactions

Haemolysis5
Methaemoglobinaemia5
Overdose3
Self-medication2
Chemical Burn Of Genitalia1
Hepatitis1
Hypophosphataemia1

Reporter sex

7 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 5 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00574-0601-15 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0574-0601-15) / 15 mL in 1 BOTTLE, WITH APPLICATOR 1990-09-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0574-0601-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00574-0601-15, written without dashes as 00574060115. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00574-0601-15, the first segment (00574) is the labeler code FDA assigned to Padagis US LLC; the middle segment (0601) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Padagis US LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Padagis US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 22 words ▾

INDICATIONS: Podocon-25 ® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata) (4) .

⏱️ Dosage and Administration 152 words ▾

DOSAGE AND ADMINISTRATION: PODOCON-25 ® IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT. SHAKE WELL.

Thoroughly cleanse affected area. Use supplied applicator to apply Podocon-25 ® sparingly to lesion. Avoid contact with healthy tissue.

Allow to dry thoroughly. Only intact (no bleeding) lesions should be treated. As podophyllin is a powerful caustic and severe irritant, it is recommended the first application of Podocon-25 ® be left in contact for only a short time (30-40 minutes) to determine patient’s sensitivity.

To avoid systemic absorption, time of contact should be minimum time necessary to produce the desired result (1 to 4 hours, depending on condition of lesion and of patient), the physician developing his/her own experience and technique. Large areas or numerous warts should not be treated at once. After treatment time has elapsed, remove dried Podocon-25 ® thoroughly with alcohol or soap and water.

⛔ Contraindications 49 words ▾

CONTRAINDICATIONS: Podocon-25 ® is contraindicated in diabetics, patients using steroids or with poor blood circulation. Podocon-25 ® should not be used on bleeding warts, moles, birthmarks or unusual warts with hair growing from them. It is recommended that Podocon-25 ® not be used during pregnancy (see Pregnancy warning below).

⚠️ Warnings 35 words ▾

WARNINGS: Podophyllin is a powerful caustic and severe irritant. Keep away from the eyes; if eye contact occurs, flush with copious amounts of warm water and consult physician or poison control center immediately for advice.

🤒 Adverse Reactions 99 words ▾

ADVERSE REACTIONS: The use of topical podophyllin has been known to result in paresthesia, polyneuritis, paralytic ileus, pyrexia, leukopenia, thrombocytopenia, coma and death (5) . Pregnancy: There have been reports of complications associated with the topical use of podophyllin on condylomata of pregnant patients including birth defects, fetal death and stillbirth (6) . In the absence of controlled safety studies, podophyllin remains contraindicated for use on pregnant patients.

Nursing Mothers: It is not known whether podophyllin is excreted in human milk following topical application. In the absence of controlled safety studies, podophyllin remains contraindicated for use on nursing patients.

🤰 Pregnancy 43 words ▾

Pregnancy: There have been reports of complications associated with the topical use of podophyllin on condylomata of pregnant patients including birth defects, fetal death and stillbirth (6) . In the absence of controlled safety studies, podophyllin remains contraindicated for use on pregnant patients.

🧬 Clinical Pharmacology 88 words ▾

CLINICAL PHARMACOLOGY: Podophyllin is a cytotoxic agent that has been used topically in the treatment of genital warts. It arrests mitosis in metaphase, an effect it shares with other cytotoxic agents such as the vinca alkaloids (2) . The active agent is podophyllotoxin, whose concentration varies with the type of podophyllin used; the American source normally containing one-fourth the amount of podophyllotoxin as the Indian source (3) .

NOTE: PODOCON-25 ® IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT.

📦 How Supplied / Storage and Handling 137 words ▾

HOW SUPPLIED: Podocon-25 ® is available in 15-mL bottles with tapered tip applicator attached inside cap. NDC 0574- 0601 -15 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Rx Only 1) Blumgarten, A.F.: Text Book of Materia Medica, Pharmacology and Therapeutics; Ed.

7, New York, The Macmillan Company, 1937, pp. 220 and 223. 2) Green, L.K., Klima, M., Burns, T.; Arch Dermatol.

Vol 124, Nov 1988, p. 1718. 3) Martindale, 28th Ed.

London, 1982, pp. 1366, 1367. 4) Medical Letter; Vol 26, New Rochelle, N.Y., 1984, p 10.

5) Fisher: Severe Systemic and Local Reactions to Topical Podophyllum Resins; Cutis, Volume 28, 1981. 6) Zackheim: Hazards of Topical Mitotic-Blocking Agents; Arch. Dermat.

Volume 113, 1977. Manufactured By Padagis Minneapolis, MN 55427 www.padagis.com 2204600 1J100 RC J1 Rev 06-22

📋 Description 73 words ▾

DESCRIPTION: Podocon-25 ® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake ( Podophyllum peltatum Linne’ ), a perennial plant of northern and middle United States (1) . The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin).

American podophyllin typically has a reduced level of podophyllotoxin (see below).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00574-0521-04 · Padagis 00574-0611-05 · Padagis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.