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Podofilox 5 mg/g Gel, 3.5 g — NDC 0574-0621-05 (Billing 00574-0621-05)

by Padagis US LLC · 3.5 g in 1 TUBE, WITH APPLICATOR

This is a package of 3.5 g of Podofilox 5 mg/g Gel from Padagis US LLC, marketed since Dec 2023 and currently FDA-listed; retail pharmacies pay about $129.99 per g (NADAC). It is this product's only package size.

NDC 00574-0621-05
🏷️ FDA NDC (as labeled) 0574-0621-05 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 0574-0621-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0574 labeler · 0621 product · 05 package
Package marketed since
Dec 13, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
4 g per package
Barcode (UPC-A, from the NDC)
3 0574062105 9
Medicaid fills, this package
2,403 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0574-0621-05
Product NDC 0574-0621
11-digit billing NDC 00574062105
NCPDP billing unit GM — per gram (weight)
RxCUI 312466
UNII L36H50F353
Application # ANDA211871
SPL Set ID d2e70c5e-d4a9-4295-9eff-517ffb974e61
Physiologic effect Decreased Mitosis
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-13
Route TOPICAL
Dosage form GEL
Substance PODOFILOX

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90750015004020
GCN Seq No 030857
GCN 23450
HICL code 006081
Ingredient (HICL) Podofilox
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 PODOFILOX 0.5% GEL
FDB brand name Podofilox
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 030857
  • GCN: 23450
  • GPI-14 (Medi-Span): 90750015004020
  • HICL (First Databank): 006081
  • AHFS class code: 84:28.00.00
  • RxCUI (RxNorm): 312466
Why two NDCs? The FDA registers this code as 0574-0621-05 — 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 → 00574-0621-05. 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.

RxNorm drug class

This medicine belongs to the Antivirals class.

Drug family (ATC) Antivirals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PODOFILOX 0.5% GEL Ingredient Podofilox
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.

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 gPer package
Retail pharmacies payNADAC · weekly $129.986 $454.95 / 3.5 g
Medicaid paysCMS SDUD · 12 mo $127.37 $445.80 / 3.5 g
Medicare drug plans payPart D · Q2 2026 $123.28 $431.46 / 3.5 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $134.782 $124.089
▼ Down 4% over the last 10 months.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00574-0621-05 You're viewing this Main listing 3.5 g in 1 TUBE, WITH APPLICATOR 2023-12-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Podofilox 5 mg/gthis 00574-0621-05 Padagis 3.5 g $129.986 — Availability likely —
Condylox 5 mg/g 00023-6118-03 Allergan, 3.5 g $172.001 — Availability likely +32%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII U3JF91U133
    Hydroxypropyl cellulose is a plant-derived polymer that acts as a binder, thickener, and film-former in medications. It helps hold tablet ingredients together, control how quickly the drug dissolves, and create protective coatings on pills.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.

6 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.

Manufacturer & labeler

LabelerPadagis US LLC
Application holderPADAGIS US LLC
FDA applicationANDA211871 (ANDA)
Labeler code00574
First marketedDec 2023
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 87 words ▾

INDICATIONS AND USAGE Podofilox gel is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis.

Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with podofilox gel.

⏱️ Dosage and Administration 204 words ▾

DOSAGE AND ADMINISTRATION The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated. Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one-week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles.

If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

Podofilox gel should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm 2 or less of wart tissue and to no more than 0.5 gram of the gel per day.

Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Podofilox gel is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

⚠️ Warnings 64 words ▾

WARNINGS Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Podofilox gel is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice. Drug Product is Flammable. Keep Away from Open Flame.

🤒 Adverse Reactions 142 words ▾

ADVERSE REACTIONS In clinical trials with podofilox gel, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment.

Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters. The most common systemic adverse event reported during the clinical studies was headache (7%).

To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 115 words ▾

Pregnancy 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m 2 , approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5 mg/kg (29.5 mg/m 2 , approximately 19 times the recommended maximum human dose.) 9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. Many antimitotic drug products are known to be embryotoxic.

There are no adequate and well-controlled studies in pregnant women. Podofilox gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 112 words ▾

OVERDOSAGE Topically applied podofilox may be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible.

10 Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure and seizures. 11 Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.

🧬 Clinical Pharmacology 98 words ▾

CLINICAL PHARMACOLOGY Mechanism of Action Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown. Pharmacokinetics In systemic absorption studies in 52 patients, topical application of 0.05 mL of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels.

Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1.0 to 4.5 hours. The drug was not found to accumulate after multiple treatments 1 .

📦 How Supplied / Storage and Handling 45 words ▾

HOW SUPPLIED Podofilox Gel 0.5% is supplied as 3.5 grams of clear gel in aluminum tubes with an applicator tip. NDC 0574-0621-05. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Avoid excessive heat. Do not freeze. Keep out of reach of children. Rx only

📋 Description 97 words ▾

DESCRIPTION Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum ). Podofilox gel is formulated for topical administration. Each gram of gel contains 5 mg of podofilox in a buffered alcoholic gel containing alcohol (81% v/v), butylated hydroxytoluene, glycerin, hydroxypropyl cellulose, lactic acid, and sodium lactate.

Podofilox has a molecular weight of 414.4 daltons, and is soluble in alcohol and sparingly soluble in water. Its chemical name is [5R,-(5α, 5aβ, 8aα, 9α]-5,8,8a,9-tetrahydro-9-hydroxy- 5-(3,4,5-trimethoxyphenyl) furo[3',4':6,7]naphtho-[2,3,-d]-1,3-dioxol-6(5aH)-one. Podofilox has the following structural formula: podofilox-structure-07-19

💬 Information for Patients 134 words ▾

Information for Patients Patients using podofilox gel should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not intended to disclose all possible adverse or intended effects.

1) This medication should be used only as directed by the health care provider. Patients should be instructed to wash their hands thoroughly before and after each application. It is for external use only.

Avoid contact with the eyes. 2) Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3) Patients should report any signs of adverse reactions to the health care provider.

4) If no improvement is observed after 4 weeks of treatment, discontinue the medication and consult the health care provider.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Data are not available on the safe and effective use of this product for treatment of warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina). The recommended method of application, frequency of application, and duration of usage should not be exceeded (see DOSAGE AND ADMINISTRATION ). Information for Patients Patients using podofilox gel should receive the following information and instructions.

This information is intended to aid in the safe and effective use of this medication. It is not intended to disclose all possible adverse or intended effects. 1) This medication should be used only as directed by the health care provider.

Patients should be instructed to wash their hands thoroughly before and after each application. It is for external use only. Avoid contact with the eyes.

2) Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3) Patients should report any signs of adverse reactions to the health care provider. 4) If no improvement is observed after 4 weeks of treatment, discontinue the medication and consult the health care provider.

Carcinogenesis, Mutagenesis and Impairment of Fertility An 80-week carcinogenicity study in the mouse was performed using a 0.5% podofilox solution applied dermally at 0.04, 0.2 and 1.0 mg/kg/day. There were no differences between the podofilox treated mice at any dose level and vehicle control in the incidence of neoplasia. Published animal studies, in general, have not shown the drug substance, podofilox, to be carcinogenic.

2,3,4,5,6 There are published reports that, in mouse studies, crude podophyllin resin (containing podofilox) applied topically to the cervix produced changes resembling carcinoma in situ . 7 These changes were reversible at five weeks after cessation of treatment. In one reported experiment, epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin 8 (the drug was applied twice weekly over a 15-month period).

Podofilox was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate, with and without metabolic activation. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to podofilox at concentrations up to 0.008 mcg/mL, without metabolic activation and 12 mcg/mL podofilox with metabolic activation. Results from the mouse micronucleus in vivo assay using podofilox 0.5% solution at doses up to 25 mg/kg (75 mg/m 2 ), indicate that podofilox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).

Daily topical application of 0.5% podofilox solution at doses up to the equivalent of 0.2 mg/kg (1.18 mg/m 2 , approximately equivalent to the human daily dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility. Pregnancy 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m 2 , approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5 mg/kg (29.5 mg/m 2 , approximately 19 times the recommended maximum human dose.) 9 Teratogenicity and embryotoxicity have not been studied with intravaginal application.

Many antimitotic drug products are known to be embryotoxic. There are no adequate and well-controlled studies in pregnant women. Podofilox gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from podofilox, a decision should be made whether to discontinue nursing or to dis… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 52 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from podofilox, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🔬 Clinical Studies 154 words ▾

CLINICAL STUDIES In the first multicenter clinical study in 326 patients with anogenital warts, podofilox gel and its vehicle were applied in a double-blind fashion to comparable patient groups. Of the 260 patients with efficacy data, 176 were treated with podofilox gel. Patients applied podofilox gel twice daily for three consecutive days followed by a 4 day “rest” period.

At the end of 4 weeks, 38.4% of the patients had complete clearing of the wart tissue when treated with podofilox gel. In the second multicenter clinical trial in 108 evaluable patients with anogenital warts, podofilox topical solution was compared with podofilox gel for efficacy. As in the first clinical trial, patients applied podofilox gel twice daily for three consecutive days followed by a four day “rest” period.

Similar clearance rates were observed. At the end of 4 weeks, 25.6% of the patients had complete clearing of the wart tissue when treated with podofilox gel.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis and Impairment of Fertility An 80-week carcinogenicity study in the mouse was performed using a 0.5% podofilox solution applied dermally at 0.04, 0.2 and 1.0 mg/kg/day. There were no differences between the podofilox treated mice at any dose level and vehicle control in the incidence of neoplasia. Published animal studies, in general, have not shown the drug substance, podofilox, to be carcinogenic.

2,3,4,5,6 There are published reports that, in mouse studies, crude podophyllin resin (containing podofilox) applied topically to the cervix produced changes resembling carcinoma in situ . 7 These changes were reversible at five weeks after cessation of treatment. In one reported experiment, epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin 8 (the drug was applied twice weekly over a 15-month period).

Podofilox was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate, with and without metabolic activation. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to podofilox at concentrations up to 0.008 mcg/mL, without metabolic activation and 12 mcg/mL podofilox with metabolic activation. Results from the mouse micronucleus in vivo assay using podofilox 0.5% solution at doses up to 25 mg/kg (75 mg/m 2 ), indicate that podofilox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).

Daily topical application of 0.5% podofilox solution at doses up to the equivalent of 0.2 mg/kg (1.18 mg/m 2 , approximately equivalent to the human daily dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility.

📚 References ~1 min read ▾

REFERENCES 1. Von Krogh G. Podophyllotoxin in serum: Absorption subsequent to three day repeated applications of a 0.5% ethanolic preparation on condylomata acuminata.

Sex Trans Disease 1982: 9: 26-33. 2. Berenblum I.

The effect of podophyllotoxin on the skin of the mouse, with reference to carcinogenic, cocarcinogenic, and anticarcinogenic action. J Cancer Inst 11:839-841, 1951. 3.

Kaminetzky HA, Swerdlow M. Podophyllin and the mouse cervix: assessment of carcinogenic potential. Am J Obst Gyn 95:486-490, 1965.

4. McGrew EA, Kaminetzky HA. The genesis of experimental cervical epithelial dysplasia.

Am J Clin Path 35:538-545, 1961. 5. Roe FJC, Salaman MH.

Further studies on incomplete carcinogenesis: triethylene melamine (T.E.M.) 1,2 benxanthracene and beta-propiolactone as initiators of skin tumor formation in the mouse. Brit J Cancer, 9:177-203, 1955. 6.

Taper HS. Induction of the deficient acid DNAase activity in mouse interfollicular epidermis by croton oil as a possible tumor promoting mechanism. Zeitschrift fur Krebsforschung and Klinisch Onkologie (Cancer Research and Clinical Oncology, Berlin) 90:197-210, 1977.

7. Kaminetzky HA, McGrew EA, Phillips RL. Experimental cervical epithelial dysplasia.

J Obst Gyn 14:1-10, 1959. 8. Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix: Effect of long term application.

Arch Path 73:481-485, 1962. 9. Thiersch JB.

Effect of podophyllin (P) and podophylotoxine (PT.) on the rat litter in utero. Soc Exptl Biol Med Proc. 113:124-127, 1963.

10. Savel H.: Clinical experience with intravenous podophyllotoxin. Proc Amer Assoc Cancer Res, 1964; 5: 56.

11. Cassidy DE, Dewry J and Fanning JP: Podophyllum toxicity: A report of a fatal case and a review of the literature. J Toxicol Clinic Toxicol 1982: 19: 35-44.

For all medical inquiries contact: Padagis Minneapolis, MN 55427 1-866-634-9120 Manufactured by: Padagis Minneapolis, MN 55427

📄 Patient Package Insert ~3 min read ▾

Patient Information Podofilox (poe dof′ il ox) Gel 0.5% Rx only Podofilox Gel and Anogenital Warts 1. APPLY PODOFILOX GEL ONLY ON THE WARTS POINTED OUT BY YOUR DOCTOR. 2.

YOU MAY FEEL SOME MILD TO MODERATE DISCOMFORT DURING TREATMENT. 3. STOP TREATMENT AND CALL YOUR DOCTOR IF YOU HAVE BLEEDING, SWELLING, OR EXCESSIVE PAIN, BURNING, OR ITCHING.

4. DO NOT USE MORE THAN TWO TIMES A DAY. 5.

DO NOT USE FOR MORE THAN THREE DAYS IN A ROW. 6. DO NOT HAVE SEXUAL INTERCOURSE ON THE DAYS YOU ARE APPLYING PODOFILOX GEL.

7. WASH HANDS AFTER EVERY USE. INTRODUCTION Podofilox gel slowly kills external anogenital warts.

The warts will change from a fleshy skin color to a dry, crusted, dead look, then disappear. Three out of four patients feel some burning or pain after they apply podofilox gel. Other side effects may include redness, soreness, tenderness, and small sores.

These usually go away within a week after podofilox gel is stopped. If pain or other side effects bother you too much, stop applying podofilox gel and contact your doctor. HOW TO USE PODOFILOX GEL Follow these and your doctor’s instructions carefully.

Apply podofilox gel only on the warts pointed out by your doctor. Do not use it on any other warts on or inside your body, or for any other skin growth. 1.

Unscrew the entire applicator cap. Invert the cap and puncture the tube seal. Replace the applicator cap.

To apply podofilox gel, remove the protective cap on the applicator tip and apply to the warts using the applicator tip or finger. Make sure to replace the applicator cap tightly after use. APPLY PODOFILOX GEL ONLY WHERE YOUR DOCTOR HAS INSTRUCTED YOU.

2. Apply a small amount of podofilox gel to the wart(s). Do not get it on normal skin.

If a wart is in a skin fold, spread the skin apart so you can reach the wart. A hand mirror can help sometimes. Let podofilox gel dry before letting the skin folds return to their normal position.

Wash your hands well with soap and water after you use podofilox gel. 3. Apply podofilox gel once in the morning and once in the evening for three days in a row.

Then stop applying podofilox gel and wait four days. Using podofilox gel like this is called a treatment week. You should not wash podofilox gel off the wart area unless you experience excessive pain, burning, or itching.

DO NOT APPLY PODOFILOX GEL MORE THAN TWICE EACH DAY OR FOR MORE THAN THREE DAYS IN A ROW. USING PODOFILOX GEL MORE OFTEN WILL NOT MAKE IT WORK BETTER BUT MAY INCREASE SIDE EFFECTS. 4.

If the warts do not go away, repeat the podofilox gel treatment for another week. You can use podofilox gel up to four treatment weeks (REMEMBER: a treatment week is twice a day for three days, then four days with no treatment). Your doctor may ask you to come back for a check-up visit during treatment.

If the warts have not gone away after four treatment weeks, stop applying podofilox gel and contact your doctor. IF THE AREA YOU ARE PUTTING PODOFILOX GEL ON IS BLEEDING OR SWOLLEN, OR IF THERE IS EXCESSIVE PAIN, BURNING OR ITCHING, STOP APPLYING PODOFILOX GEL AND CONTACT YOUR DOCTOR. 5.

Anogenital warts can come back. If your warts come back, contact your doctor. SPECIAL CAUTIONS • Anogenital warts are contagious.

You can give them to or get them from your sexual partner. Make sure your sexual partner has been checked for anogenital warts. Condoms may help prevent giving anogenital warts to your sexual partner.

Do not have sexual intercourse for the three days you are applying podofilox gel. • Women should make sure to use birth control so they will not get pregnant while on podofilox gel. The effects on the unborn baby are not known. Women can use podofilox gel during their menstrual period. • Podofilox gel is prescribed only for your external anogenital warts.

Do not let anyone else use it. • Drug Product is Flammable. Keep Away from Open Flame. REMEMBER • Always wash your hands after using podofilox gel. • Do not get it in your eyes.

If you do, immediately flush your eyes with water a… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 18 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Rx Only NDC 0574-0621-05 Podofilox Gel 0.5% FOR TOPICAL USE ONLY 3.5 g carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.4K
Units reimbursed last 4 qtrs
8.7K
Gross reimbursed last 4 qtrs
$1.1M
Avg / prescription
$459.82
Avg / unit
$127.37
Latest quarter Q1 2026
238Rx
Medicaid pays / g
$127.37
gross reimbursed
vs
NADAC / g
$129.99
acquisition cost
=
Spread
−$2.6187
-2% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
74% FFS 26% MCO
Fee-for-service · 1,767 Rx Managed care · 636 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,577 units · 8.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 686 units · 5.5 per 100k residents IL Indiana: 56 units · 0.8 per 100k residents IN Ohio: 945 units · 8.0 per 100k residents OH Pennsylvania: 74 units · 0.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,085 units · 10.5 per 100k residents CA Utah: no data reported UT Colorado: 364 units · 6.2 per 100k residents CO Nebraska: no data reported NE Missouri: 284 units · 4.6 per 100k residents MO Kentucky: 284 units · 6.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 53 units · 1.5 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 70 units · 1.0 per 100k residents TN North Carolina: 91 units · 0.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 46 units · 1.1 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 63 units · 0.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.210.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 10.5 /100k
2 New York 8.1 /100k
3 Ohio 8.0 /100k
4 Kentucky 6.3 /100k
5 Colorado 6.2 /100k
6 Illinois 5.5 /100k
7 Missouri 4.6 /100k
8 Connecticut 1.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Podofilox — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Podofilox. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$49.1K
Claims incl. refills
404
Beneficiaries
370
Spend / beneficiary
$132.64
Spend / claim
$121.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 PODOFILOX — the ingredient across all brands.

Top reported reactions

Pain17
Anxiety13
Emotional Distress11
Anhedonia10
Application Site Pain9
Renal Failure9
Chronic Kidney Disease8

Age at onset

Adult16
Elderly4

Reporter sex

109 reports
Male · 66%
Female · 34%

Serious outcomes

Hospitalization24
Life-threatening2
Death2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8 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.
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.