Vtama tapinarof 10 mg/g Cream — NDC 81672-5051-1 (Billing 81672-5051-01)
This is a package of Vtama tapinarof 10 mg/g Cream from Organon LLC, marketed since May 2025 and currently FDA-listed; retail pharmacies pay about $25.23 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 81672-5051-1 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 81672 labeler · 5051 product · 1 package
- Package marketed since
- May 28, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 8167250511 7
- Medicaid fills, this package
- 32,647 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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 083417
- GCN: 52374
- GPI-14 (Medi-Span): 90250075003720
- HICL (First Databank): 048031
- AHFS class code: 84:24.12.00
- RxCUI (RxNorm): 2602301
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Aryl Hydrocarbon Receptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Vtama cream treats plaque psoriasis in adults. It also treats atopic dermatitis, or eczema, in adults and children 2 and older.
- Put a thin layer on the affected skin once a day. Wash your hands afterward unless you are treating your hands. Keep it out of your mouth, eyes and vagina.
- The most common is folliculitis, which is irritated hair follicles. Some people get skin rash, itching, headache or cold-like symptoms. Let your doctor know if a rash or skin react...
- For atopic dermatitis, yes, in children 2 and older. It has not been shown to be safe and effective for psoriasis in children, or for eczema under age 2.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tapinarof — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $25.231 | $1,513.83 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $24.27 | $1,456.48 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $25.56 | $1,533.54 / 60 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 81672-5051-01 You're viewing this Main listing | 1 TUBE in 1 PACKAGE / 60 g in 1 TUBE | 2022-05-26 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vtama 10 mg/gthis 81672-5051-01 | Organon | 1 tube | $25.231 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11590088 ↗ | Method of use | U-2625 | Nov 13, 2039 |
| US 10426743 ↗ | Method of use | U-4048 | May 19, 2036 |
| US 11612573 ↗ | Method of use | U-4048 | May 19, 2036 |
| US 11612573 ↗ | Method of use | U-2625 | May 19, 2036 |
| US 11497718 ↗ | Method of use | U-4048 | Nov 13, 2039 |
| US 11938099 ↗ | Method of use | U-4048 | Nov 13, 2039 |
| US 10426743 ↗ | Method of use | U-2625 | May 19, 2036 |
| US 12569453 ↗ | Method of use | U-4048 | Dec 18, 2039 |
| US 10647649 ↗ | Drug substance | — | Nov 13, 2038 |
| US 11617724 ↗ | Drug product | — | May 19, 2036 |
| US 11597692 ↗ | Drug substance | — | Nov 13, 2038 |
| US 10195160 ↗ | Drug product | — | May 23, 2036 |
| US 11622945 ↗ | Drug product | — | May 19, 2036 |
| US 11458108 ↗ | Drug product | — | May 19, 2036 |
| Code | What it grants | Expires |
|---|---|---|
| I-956 | New indication (3-year) | Dec 12, 2027 |
| NCE | New Chemical Entity (5-year) | May 23, 2027 |
Is there a generic version of VTAMA 1% CREAM?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Tapinarof Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
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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.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII A1A1I8X02B
A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII Q504PL8E0V
A waxy emulsifier blend derived from sorbitan and polyethylene glycol. It helps mix oil and water-based ingredients together and is commonly used in creams and ointments to create a smooth, uniform texture.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII V56DFE46J5
Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
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UNII L0Q8IK9E08
A synthetic compound made from stearic acid and polyethylene glycol. It acts as an emulsifier and solubilizer, helping mix oil and water-based ingredients and keeping them blended throughout the medicine's shelf life.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. ( 1.2 )
1.1Plaque Psoriasis VTAMA ® cream is indicated for the topical treatment of plaque psoriasis in adults.
1.2Atopic Dermatitis VTAMA cream is indicated for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer of VTAMA cream to affected areas once daily. Wash hands after application, unless VTAMA cream is for treatment of the hands. VTAMA cream is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of VTAMA cream to affected areas once daily. ( 2 ) VTAMA cream is not for oral, ophthalmic, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cream, 1% Each gram of VTAMA cream contains 10 mg of tapinarof in a white to off-white cream. Cream, 1% ( 3 ) Each gram of VTAMA cream contains 10 mg of tapinarof. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS In plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. ( 6.1 ) In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (PSOARING 1 and PSOARING 2), 1025 adults with plaque psoriasis were treated with VTAMA cream or received vehicle cream once daily for up to 12 weeks.
Subjects ranged in age from 18 to 75 years, with an overall median age of 51 years. The majority of subjects were White (85%) and male (57%); and 85% identified as non-Hispanic or Latino. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle.
Table 1: Adverse Reactions Occurring in ≥1% of Adult Subjects with Plaque Psoriasis (and More Frequently than Vehicle) in the 12-week PSOARING 1 and PSOARING 2 Clinical Trials Adverse Reaction VTAMA cream N=683 n (%) Vehicle cream N=342 n (%) Folliculitis Folliculitis includes application site folliculitis and folliculitis 140 (20) 3 (1) Nasopharyngitis Nasopharyngitis includes nasopharyngitis, nasal congestion, pharyngitis, respiratory tract infection (RTI) viral, rhinorrhea, sinus congestion, upper RTI, and viral upper RTI 73 (11) 31 (9) Contact dermatitis Contact dermatitis includes dermatitis, contact dermatitis, hand dermatitis, and rash 45 (7) 2 (1) Headache Headache includes headache, migraine, and tension headache 26 (4) 5 (1) Pruritus Pruritus includes application site pruritus, pruritus, generalized pruritus, and genital pruritus 20 (3) 2 (1) Influenza Influenza includes influenza and influenza-like illness 14 (2) 2 (1) Two (0.3%) subjects using VTAMA cream developed urticaria.
Adverse reactions leading to treatment discontinuation in >1% of subjects who received VTAMA cream were contact dermatitis (2.9%) and folliculitis (2.8%). In an open label safety trial (PSOARING 3), 763 subjects were treated for up to an additional 40 weeks after completing PSOARING 1 or PSOARING 2. In addition to the adverse reactions reported in the 12-week PSOARING 1 and PSOARING 2 clinical trials, the following adverse reactions were reported: urticaria (1.0%) and drug eruption (0.7%).
Atopic Dermatitis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (ADORING 1 and ADORING 2), 811 adult and pediatric subjects 2 years of age and older with atopic dermatitis were treated with VTAMA cream or received vehicle cream once daily for up to 8 weeks. Subjects ranged in age from 2 to 81 years, with an overall median age of 11 years. The majority (51%) of subjects were White, 31% were Black, 12% were Asian; 54% were female; and 78% of subjects identified as non-Hispanic or Latino.
Table 2 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle. Table 2: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 2 Years and Older with Atopic Dermatitis (and More Frequently than Vehicle) in the 8 week ADORING 1 and ADORING 2 Clinical Trials Adverse Reaction VTAMA cream N=541 n (%) Vehicle cream N=270 n (%) Upper respiratory tract i… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary The available data on VTAMA cream use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of tapinarof to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 264 and 16 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, tapinarof was administered by subcutaneous injection to pregnant animals at doses of 1.2, 6.9 and 34 mg/kg/day during the period of organogenesis.
Tapinarof was not associated with embryofetal lethality or fetal malformations. Tapinarof increased the incidence of skeletal variations (incomplete ossification of nasal bones) at the dose of 34 mg/kg/day (264 times the MRHD based on AUC comparisons). In an embryofetal development study in rabbits, tapinarof was administered by subcutaneous injection to pregnant animals twice daily at doses of 0.3, 1, and 3 mg/kg/day during the period of organogenesis.
Maternal toxicity as evidenced by decreased maternal body weight gain and associated increased post-implantation loss (embryolethality) was observed at 3 mg/kg/day. In addition, fetal skeletal variations were observed at 3 mg/kg/day. Tapinarof was not associated with embryofetal lethality or fetal malformations at doses up to 1 mg/kg/day (16 times the MRHD based on AUC comparison) or fetal malformations at doses up to 3 mg/kg/day (30 times the MRHD based on AUC comparison).
In a second embryofetal development study in rabbits, tapinarof was administered by continuous subcutaneous infusion to pregnant animals at doses of 1, 2 and 3 mg/kg/day during the period of organogenesis. Tapinarof was not associated with embryofetal lethality or fetal malformations at doses up to 3 mg/kg/day (20 times the MRHD based on AUC comparison). In a prenatal and postnatal development study, tapinarof was administered by subcutaneous injection to pregnant rats at doses of 1, 6 and 30 mg/kg/day beginning on gestation day 6 through lactation day 20.
Maternal toxicity associated with decreases in body weight gain and food consumption was noted at 30 mg/kg/day (264 times the MRHD based on AUC comparisons). Tapinarof decreased fetal survival and viability that resulted in reduced litter sizes and decreased fetal weights at doses greater than or equal to 6 mg/kg/day (44 times the MRHD based on AUC comparisons). No tapinarof-related effects on fetal survival and viability were noted at a dose of 1 mg/kg/day (6 times the MRHD based on AUC comparisons).
No tapinarof-related effects on postnatal development, neurobehavioral or reproductive performance of offspring were noted at doses up to 30 mg/kg/day (264 times the MRHD based on AUC comparison).
8.2Lactation Risk Summary No data are available regarding the presence of tapinarof in human milk or the effects of tapinarof on the breastfed infant, or on milk production. Tapinarof was detected in rat offspring following subcutaneous administration to pregnant female rats which suggests that tapinarof was transferred into the milk of lactating rats (see Data ) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VTAMA cream and any potential adverse effects on the breastfed infant from VTAMA cream or from t… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data on VTAMA cream use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of tapinarof to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 264 and 16 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, tapinarof was administered by subcutaneous injection to pregnant animals at doses of 1.2, 6.9 and 34 mg/kg/day during the period of organogenesis.
Tapinarof was not associated with embryofetal lethality or fetal malformations. Tapinarof increased the incidence of skeletal variations (incomplete ossification of nasal bones) at the dose of 34 mg/kg/day (264 times the MRHD based on AUC comparisons). In an embryofetal development study in rabbits, tapinarof was administered by subcutaneous injection to pregnant animals twice daily at doses of 0.3, 1, and 3 mg/kg/day during the period of organogenesis.
Maternal toxicity as evidenced by decreased maternal body weight gain and associated increased post-implantation loss (embryolethality) was observed at 3 mg/kg/day. In addition, fetal skeletal variations were observed at 3 mg/kg/day. Tapinarof was not associated with embryofetal lethality or fetal malformations at doses up to 1 mg/kg/day (16 times the MRHD based on AUC comparison) or fetal malformations at doses up to 3 mg/kg/day (30 times the MRHD based on AUC comparison).
In a second embryofetal development study in rabbits, tapinarof was administered by continuous subcutaneous infusion to pregnant animals at doses of 1, 2 and 3 mg/kg/day during the period of organogenesis. Tapinarof was not associated with embryofetal lethality or fetal malformations at doses up to 3 mg/kg/day (20 times the MRHD based on AUC comparison). In a prenatal and postnatal development study, tapinarof was administered by subcutaneous injection to pregnant rats at doses of 1, 6 and 30 mg/kg/day beginning on gestation day 6 through lactation day 20.
Maternal toxicity associated with decreases in body weight gain and food consumption was noted at 30 mg/kg/day (264 times the MRHD based on AUC comparisons). Tapinarof decreased fetal survival and viability that resulted in reduced litter sizes and decreased fetal weights at doses greater than or equal to 6 mg/kg/day (44 times the MRHD based on AUC comparisons). No tapinarof-related effects on fetal survival and viability were noted at a dose of 1 mg/kg/day (6 times the MRHD based on AUC comparisons).
No tapinarof-related effects on postnatal development, neurobehavioral or reproductive performance of offspring were noted at doses up to 30 mg/kg/day (264 times the MRHD based on AUC comparison).
🧒 Pediatric Use ▾
8.4Pediatric Use Plaque Psoriasis The safety and efficacy of VTAMA cream for the topical treatment of plaque psoriasis have not been established in pediatric patients. Atopic Dermatitis The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of VTAMA cream for this indication is supported by evidence from two adequate and well-controlled trials (ADORING 1 and ADORING 2), which included 654 pediatric subjects 2 years of age and older (436 of whom received VTAMA cream) with moderate to severe atopic dermatitis.
Adverse reactions occurring more frequently in pediatric subjects compared to adults were upper respiratory tract infection and ear infection [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.2) ]. The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have not been established in pediatric patients younger than 2 years of age. Juvenile Animal Toxicity Data In a juvenile animal toxicity study, tapinarof was administered by subcutaneous injection to juvenile rats at doses of 1, 10 and 20 mg/kg/day from postnatal day (PND) 7 to 21 and at doses of 1.5, 15, and 30 mg/kg/day from PND 22 to 77.
The dose escalation conducted at PND 22 was implemented to maintain consistent systemic exposure across the duration of the dosing period. Renal pelvic dilatation was observed at doses greater than or equal to 15 mg/kg/day (165 times the MRHD based on AUC comparisons). No adverse effects in juvenile animals were noted at 1.5 mg/kg/day (11 times the MRHD based on AUC comparisons).
🧓 Geriatric Use ▾
8.5Geriatric Use Plaque Psoriasis Of the 683 subjects exposed to VTAMA cream in the PSOARING 1 or PSOARING 2 clinical trials, 99 (14.5%) were 65 years of age and older, including 8 (1.2%) subjects who were 75 years of age and older. No overall differences in efficacy, safety, or tolerability of VTAMA cream were observed between subjects 65 years of age and older and younger adult subjects. Atopic Dermatitis Of the 541 subjects exposed to VTAMA cream in the ADORING 1 or ADORING 2 clinical trials, 20 (3.7%) were 65 years of age and older, including 4 (0.7%) subjects who were 75 years of age and older.
No overall differences in efficacy, safety, or tolerability were observed between subjects 65 years of age and older and younger adult subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic actions are unknown.
12.2Pharmacodynamics Pharmacodynamics of VTAMA cream are unknown. Cardiac Electrophysiology At the approved recommended dosage, VTAMA cream does not prolong the QTc interval to any clinically relevant extent.
12.3Pharmacokinetics The plasma concentrations of tapinarof were higher in pediatric subjects 2 years of age and older with atopic dermatitis when compared to adult subjects with plaque psoriasis. Absorption Adults with Plaque Psoriasis No accumulation was observed with repeat topical application. Plasma concentration of tapinarof was below the quantifiable limits (BQL) of the assay (lower limit of quantification was 50 pg/mL) in 68% of the PK samples.
On Day 1, mean ± SD values of C max and AUC 0-last were 0.90 ± 1.4 ng/mL and 4.1 ± 6.3 ng.h/mL, respectively, following a mean daily dose of 5.23 g applied to a mean body surface area (BSA) involvement of 27.2% (range 21 to 46%) in 21 subjects with moderate to severe plaque psoriasis. On Day 29, the mean ± SD C max and AUC 0-last were 0.12 ± 0.15 ng/mL and 0.61 ± 0.65 ng.h/mL, respectively. Pediatric Subjects with Atopic Dermatitis The PK of VTAMA cream were investigated in 36 pediatric subjects 2 years of age and older with moderate to severe atopic dermatitis and a mean ± SD BSA involvement of 43% ± 15% (range 26% to 90%).
In this study, subjects applied approximately 3.2 g/day for 27 days. Plasma concentrations were BQL in 25% of PK samples on Day 1 and 76% of PK samples on Day 28. On Day 1, the mean ± SD C max and AUC 0-last were 2.4 ± 3.9 ng/mL and 4.7 ± 5.6 ng.h/mL, respectively in the overall pediatric population with atopic dermatitis.
The mean ± SD C max and AUC 0-last on Day 1 in pediatric subjects with atopic dermatitis stratified by age is shown in Table 3. Table 3: Pharmacokinetic Parameters of Tapinarof by Age Group in Pediatric Subjects with Atopic Dermatitis PK Parameter (Mean ± SD) 2 – 6 Years 7 – 11 Years 12 – 17 Years C ꚍ : concentration at the end of 24 h dosing interval on Day 28. Day 1 C max (ng/mL) 3.8 ± 5.87 2.2 ± 2.5 1.3 ±
1.8AUC 0-t (ng.h/mL) 5.5 ± 6.2 5.2 ± 5.9 3.3 ±
4.8Day 28 C ꚍ (ng/mL) 0.046 ± 0.107 0.089 ± 0.130 0.125 ± 0.413 Distribution Human plasma protein binding of tapinarof is approximately 99% in vitro . Elimination Metabolism Tapinarof is metabolized in the liver by multiple pathways including oxidation, glucuronidation, and sulfation in vitro . Drug Interaction Studies In Vitro Studies Cytochrome P450 (CYP) Enzymes: Tapinarof is not an inhibitor of CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4/5.
Tapinarof is not an inducer of CYP1A2, CYP2B6 or CYP3A4. Transporter Systems: Tapinarof is not an inhibitor of BCRP, MATE1, MATE-2K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or P-gp. Tapinarof is not a substrate for BCRP, OATP1B1, OATP1B3, or P-gp.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic actions are unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING VTAMA (tapinarof) cream, 1% is a white to off-white cream. Each gram of VTAMA cream contains 10 mg of tapinarof. It is supplied in the following size: 60 g laminated tubes: NDC 81672-5051-1 Storage and Handling: - Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. - Do not freeze. - Protect from exposure to excessive heat.
📋 Description ▾
11 DESCRIPTION VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder.
Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl- trans -stilbene, also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C 17 H 18 O 2 , a molecular weight of 254.32, and the following structural formula. Each gram of VTAMA cream for topical use contains 10 mg of tapinarof in a white to off-white cream. VTAMA cream also contains the following inactive ingredients: benzoic acid, butylated hydroxytoluene, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate. figure1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Administration Instructions [see Dosage and Administration (2) ] Instruct patients to apply VTAMA cream once daily to affected skin lesions only and avoid unaffected areas of skin. Advise patients to wash hands after application unless VTAMA cream is for treatment of the hands.
Advise patients that VTAMA cream is for external use only. Dist. by: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA For patent information: www.organon.com/our-solutions/patent/ vIGA-AD is the trademark of Eli Lilly and Co. © 2025 Organon group of companies. All rights reserved. uspi-og0505-cr-2505r000
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The plasma concentrations of tapinarof were higher in pediatric subjects 2 years of age and older with atopic dermatitis when compared to adult subjects with plaque psoriasis. Absorption Adults with Plaque Psoriasis No accumulation was observed with repeat topical application. Plasma concentration of tapinarof was below the quantifiable limits (BQL) of the assay (lower limit of quantification was 50 pg/mL) in 68% of the PK samples.
On Day 1, mean ± SD values of C max and AUC 0-last were 0.90 ± 1.4 ng/mL and 4.1 ± 6.3 ng.h/mL, respectively, following a mean daily dose of 5.23 g applied to a mean body surface area (BSA) involvement of 27.2% (range 21 to 46%) in 21 subjects with moderate to severe plaque psoriasis. On Day 29, the mean ± SD C max and AUC 0-last were 0.12 ± 0.15 ng/mL and 0.61 ± 0.65 ng.h/mL, respectively. Pediatric Subjects with Atopic Dermatitis The PK of VTAMA cream were investigated in 36 pediatric subjects 2 years of age and older with moderate to severe atopic dermatitis and a mean ± SD BSA involvement of 43% ± 15% (range 26% to 90%).
In this study, subjects applied approximately 3.2 g/day for 27 days. Plasma concentrations were BQL in 25% of PK samples on Day 1 and 76% of PK samples on Day 28. On Day 1, the mean ± SD C max and AUC 0-last were 2.4 ± 3.9 ng/mL and 4.7 ± 5.6 ng.h/mL, respectively in the overall pediatric population with atopic dermatitis.
The mean ± SD C max and AUC 0-last on Day 1 in pediatric subjects with atopic dermatitis stratified by age is shown in Table 3. Table 3: Pharmacokinetic Parameters of Tapinarof by Age Group in Pediatric Subjects with Atopic Dermatitis PK Parameter (Mean ± SD) 2 – 6 Years 7 – 11 Years 12 – 17 Years C ꚍ : concentration at the end of 24 h dosing interval on Day 28. Day 1 C max (ng/mL) 3.8 ± 5.87 2.2 ± 2.5 1.3 ±
1.8AUC 0-t (ng.h/mL) 5.5 ± 6.2 5.2 ± 5.9 3.3 ±
4.8Day 28 C ꚍ (ng/mL) 0.046 ± 0.107 0.089 ± 0.130 0.125 ± 0.413 Distribution Human plasma protein binding of tapinarof is approximately 99% in vitro . Elimination Metabolism Tapinarof is metabolized in the liver by multiple pathways including oxidation, glucuronidation, and sulfation in vitro . Drug Interaction Studies In Vitro Studies Cytochrome P450 (CYP) Enzymes: Tapinarof is not an inhibitor of CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4/5.
Tapinarof is not an inducer of CYP1A2, CYP2B6 or CYP3A4. Transporter Systems: Tapinarof is not an inhibitor of BCRP, MATE1, MATE-2K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or P-gp. Tapinarof is not a substrate for BCRP, OATP1B1, OATP1B3, or P-gp.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Pharmacodynamics of VTAMA cream are unknown. Cardiac Electrophysiology At the approved recommended dosage, VTAMA cream does not prolong the QTc interval to any clinically relevant extent.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Plaque Psoriasis Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted to evaluate the safety and efficacy of VTAMA cream for the treatment of adults with plaque psoriasis (PSOARING 1 [NCT03956355] and PSOARING 2 [NCT03983980]). These trials were conducted in a total of 1025 subjects randomized 2:1 to VTAMA cream or vehicle cream applied once daily for 12 weeks to any lesion regardless of anatomic location. Baseline disease severity was graded using the 5-point Physician’s Global Assessment (PGA).
The majority of subjects had “Moderate” disease (82%), while 10% had “Mild” disease, and 8% had “Severe” disease at baseline. The extent of disease involvement assessed by mean body surface area (BSA), excluding the scalp, palms, and soles, was 8% (range 3 to 20%). Subjects ranged in age from 18 to 75 years, with a median age of 51 years.
Overall, 57% of the subjects were male and 85% were White. The primary efficacy endpoint in both studies was the proportion of subjects who achieved treatment success, defined as a PGA score of “Clear” (0) or “Almost Clear” (1) and at least a 2-grade improvement from baseline. Efficacy results from the two trials are summarized in Table 4.
Table 4: Clinical Response at Week 12 in PSOARING 1 and PSOARING 2 in Adults with Plaque Psoriasis (Intent-to-Treat; Multiple Imputation) Clinical Response PSOARING 1 PSOARING 2 VTAMA cream N=340 Vehicle cream N=170 VTAMA cream N=343 Vehicle cream N=172 PGA Treatment Success Treatment success was defined as a PGA score of “Clear” or “Almost Clear” and at least a 2-grade improvement from baseline. 36% 6% 40% 6% Difference (95% CI) 29% (22%, 36%) 34% (27%, 41%) Following 12 weeks of treatment, 73 subjects randomized to VTAMA achieved complete disease clearance (PGA 0) and had VTAMA withdrawn.
These subjects were followed for up to 40 additional weeks with a median time to first worsening (PGA ≥ 2 [“Mild”]) of 114 days (95% CI: 85, 142).
14.2Atopic Dermatitis Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted to evaluate the safety and efficacy of VTAMA cream for the treatment of adult and pediatric subjects 2 years of age and older with atopic dermatitis (ADORING 1 [NCT05014568] and ADORING 2 [NCT05032859]). These trials were conducted in a total of 813 subjects (80% of subjects were 2 to 17 years of age) randomized 2:1 to VTAMA cream or vehicle cream applied once daily for 8 weeks to any lesion regardless of anatomic location.
Baseline disease severity was graded using the 5-point validated Investigator’s Global Assessment (vIGA-AD™). The majority of subjects had “Moderate” disease (87%), while 13% had “Severe” disease at baseline. The extent of disease involvement assessed by mean affected BSA, excluding the scalp, was 16.8% (range 5 to 44%).
The mean baseline Eczema Area and Severity Index (EASI) score was 12.9 (range 4.4 to 36.0). The mean baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score for subjects 12 years of age and older was 6.4 on a scale of 0-10. Subjects ranged in age from 2 to 81 years, with a median age of 11 years.
Overall, 54% of the subjects were female, 51% were White, 31% were Black, and 12% were Asian. For ethnicity, 78% of subjects identified as non-Hispanic or Latino. The primary efficacy endpoint in both trials was the proportion of subjects who achieved treatment success, defined as a vIGA-AD score of “Clear” (0) or “Almost Clear” (1) and at least a 2-grade improvement from baseline.
Efficacy was also assessed using a ≥ 4-point improvement in PP-NRS score in subjects 12 years of age and older. Efficacy results from the two trials are summarized in Table 5. Table 5: Clinical Response at Week 8 in ADORING 1 and ADORING 2 in Adult and Pediatric Subjects with Atopic Dermatitis (Intent-to-Treat; Multiple Imputation) ADORING 1 ADORING 2 VTAMA cream Vehicle cream VTAMA cream Vehicle cream Number of subjects randomized 270 137 271 135 vIGA-AD Treatment… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies were conducted in mice (daily topical administration at doses of 0.5, 1.5 and 3% tapinarof cream) and in rats (subcutaneous administration at doses of 0.1, 0.3, and 1 mg/kg/day tapinarof). No drug-related neoplasms were noted in mice after 98 (females) to 102 (males) weeks of daily topical administration at doses up to 3% tapinarof cream (44 times the MRHD based on AUC comparisons). No drug-related neoplasms were noted in female rats after 83 weeks of daily subcutaneous administration at doses up to 1 mg/kg/day tapinarof (9 times the MRHD based on AUC comparisons).
Tapinarof revealed no evidence of mutagenicity or clastogenicity in an Ames assay, an in vitro mammalian chromosomal aberration assay, an in vitro mouse lymphoma assay and two in vivo micronucleus-assays in mice and rats. Tapinarof did not impair female fertility at subcutaneous doses up to 30 mg/kg/day (264 times the MRHD based on AUC comparisons).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies were conducted in mice (daily topical administration at doses of 0.5, 1.5 and 3% tapinarof cream) and in rats (subcutaneous administration at doses of 0.1, 0.3, and 1 mg/kg/day tapinarof). No drug-related neoplasms were noted in mice after 98 (females) to 102 (males) weeks of daily topical administration at doses up to 3% tapinarof cream (44 times the MRHD based on AUC comparisons). No drug-related neoplasms were noted in female rats after 83 weeks of daily subcutaneous administration at doses up to 1 mg/kg/day tapinarof (9 times the MRHD based on AUC comparisons).
Tapinarof revealed no evidence of mutagenicity or clastogenicity in an Ames assay, an in vitro mammalian chromosomal aberration assay, an in vitro mouse lymphoma assay and two in vivo micronucleus-assays in mice and rats. Tapinarof did not impair female fertility at subcutaneous doses up to 30 mg/kg/day (264 times the MRHD based on AUC comparisons).
📄 Patient Package Insert ▾
PATIENT INFORMATION VTAMA ® (Vee-TAM-uh) (tapinarof) cream, for topical use This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 5/2025 Important information: VTAMA cream is for use on the skin (topical use) only.
Do not use VTAMA cream in your eyes, mouth, or vagina. What is VTAMA cream? VTAMA cream is a prescription medicine used on the skin (topical) to treat: plaque psoriasis in adults. atopic dermatitis in adults and children 2 years of age and older.
It is not known if VTAMA cream is safe and effective for the topical treatment of plaque psoriasis in children. It is not known if VTAMA cream is safe and effective for the topical treatment of atopic dermatitis in children under 2 years of age. Before using VTAMA cream, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.
It is not known if VTAMA cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if VTAMA cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VTAMA cream.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use VTAMA cream? Use VTAMA cream exactly as your healthcare provider tells you to use it.
Apply a thin layer of VTAMA cream only to the affected skin areas 1 time a day. Avoid applying VTAMA cream to unaffected areas of your skin. Wash your hands after applying VTAMA cream unless you are using it to treat your hands.
If someone else applies VTAMA cream for you, they should wash their hands after application. What are the possible side effects of VTAMA cream? The most common side effects of VTAMA cream in people treated for plaque psoriasis include : red raised bumps around the hair pores (folliculitis) pain or swelling in the nose and throat (nasopharyngitis) skin rash or irritation including itching and redness, peeling, burning, or stinging headache flu The most common side effects of VTAMA cream in people treated for atopic dermatitis include : upper and lower respiratory tract infections red raised bumps around the hair pores (folliculitis) headache asthma vomiting ear infection pain in extremity stomach-area (abdominal) pain VTAMA cream can also cause skin reactions at the treatment site.
Tell your healthcare provider if you have itching, irritation, pain, redness, burning or changes in skin color at the treatment site. These are not all the possible side effects of VTAMA cream. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. How should I store VTAMA cream? Store VTAMA cream at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze VTAMA cream. Protect VTAMA cream from exposure to excessive heat. Keep VTAMA cream and all medicines out of the reach of children.
General information about the safe and effective use of VTAMA cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VTAMA cream for a condition for which it was not prescribed.
Do not give VTAMA cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VTAMA cream that is written for health professionals.
What are the ingredients in VTAMA cream? Active ingredient: tapinarof Inactive ingredients: benzoic acid, butylated hydroxytoluene, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate. Dist. by: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA For patent information: www.organon.com/our-sol… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1.2 ) 12/2024
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 81672-5051-1 Rx only VTAMA ® (tapinarof) cream 1% For topical use only. 60g PRINCIPAL DISPLAY PANEL - 60g Carton
PRINCIPAL DISPLAY PANEL NDC 81672-5051-1 Rx only VTAMA ® (tapinarof) cream 1% For topical use only. 60g PRINCIPAL DISPLAY PANEL -