Prescription medicine
Penciclovir Brand names: Denavir
Penciclovir (Denavir) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $52.15 per gram (Penciclovir 1% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the penciclovir FDA label on DailyMed (effective September 4, 2019, Mylan Pharmaceuticals Inc.); the NDA 20629 record on Drugs@FDA; every penciclovir label on DailyMed.
Highlights of the record
FDA label of September 4, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePenciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.
Forms and strengths
- 10 mg/g
Cream.
On the market
- Earliest approval on file
- September 24, 1996 Denavir, Mylan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first November 9, 2022; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $52.15 per gram Penciclovir 1% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 359 through July 30, 2026
What is penciclovir used for?
From the label: indications and usagePenciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older.
Conditions named in the indications of penciclovir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor.
Source: FDA drug label (Penciclovir), Mylan Pharmaceuticals Inc., effective September 4, 2019 (SPL set 9cb88c28-d9c9-45e3-b4fe-083327f122de), via openFDA; the full label on DailyMed
Is there a generic for penciclovir (Denavir)?
The FDA approved the first generic penciclovir on November 9, 2022. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists penciclovir from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2022 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for penciclovir (Denavir)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $52.15 per gram (Penciclovir 1% cream), up 7% from $48.95 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Penciclovir 1% cream (generic)
- Denavir 1% cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Penciclovir 1% cream | Generic | $52.15 per gram | n/a | +7% |
| Denavir 1% cream | Brand | $155.08 per gram | n/a | -0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the penciclovir label say about other medicines?
The penciclovir label names no other medicine on this site. The labels of 1 other medicine name penciclovir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name penciclovir
Source: FDA drug label (Penciclovir), Mylan Pharmaceuticals Inc., effective September 4, 2019 (SPL set 9cb88c28-d9c9-45e3-b4fe-083327f122de), via openFDA; the full label on DailyMed
What do FAERS reports show for penciclovir?
The FDA Adverse Event Reporting System holds 359 reports that list penciclovir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 92 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as penciclovir?
3 other medicines are given the same way (topical) and in the same FDA class as penciclovir or labeled mainly for the same use (herpes and shingles), the same class first. Herpes and shingles lists all 15 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acyclovir | Herpes and shingles | 19 labelers | $0.346 per gram 5% ointment | No current entry |
| Acyclovir and hydrocortisone | Herpes and shingles | none listed | n/a | No current entry |
| Allantoin | Herpes and shingles | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as penciclovir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to penciclovir
- 3 medicines for the same use
- Other herpesvirus nucleoside analog dna polymerase inhibitors
- the pharmacologic class, with prices and generics
- Penciclovir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other