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Acyclovir 50 mg/g Cream — NDC 72578-0101-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acyclovir 50 mg/g Cream — NDC 72578-101-04 (Billing 72578-0101-04)

by Viona Pharmaceuticals Inc · 1 TUBE in 1 CARTON / 2 g in 1 TUBE

This is a package of Acyclovir 50 mg/g Cream from Viona Pharmaceuticals Inc, marketed since Mar 2023 and currently FDA-listed.

NDC 72578-0101-04
🏷️ FDA NDC (as labeled) 72578-101-04 billing pads the product segment with a zero
This package
Contains2 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $13.26/unit — full pricing hub ↓
Product page 72578-0101-05 Also comes in: 5 g 72578-101-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 72578-101-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72578 labeler · 101 product · 04 package
Package marketed since
Mar 3, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7257810104 6
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72578-101-04
Product NDC 72578-101
11-digit billing NDC 72578010104
RxCUI 141859
UNII X4HES1O11F
Application # ANDA206770
SPL Set ID a2966b6d-c6c0-4afd-8eda-045df497cb9d
Established class (EPC) Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of action DNA Polymerase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-03
Route TOPICAL
Dosage form CREAM
Substance ACYCLOVIR
TE code (Orange Book) BX · RLD · RS

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

GPI-14 90350010003720
GCN Seq No 018315
GCN 62420
HICL code 004183
Ingredient (HICL) Acyclovir
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5V
Therapeutic class — specific (HIC3) Topical Antivirals
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name ACYCLOVIR 5% CREAM
FDB brand name Acyclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 018315
  • GCN: 62420
  • GPI-14 (Medi-Span): 90350010003720
  • HICL (First Databank): 004183
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 141859
Why two NDCs? The FDA registers this code as 72578-101-04 — a 5-3-2 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 product segment → 72578-0101-04. 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 Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Antivirals
How it works DNA Polymerase Inhibitors
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 ACYCLOVIR 5% CREAM Ingredient Acyclovir
📖 What it is MedlinePlus · NLM

Acyclovir cream is used to treat cold sores (fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. Acyclovir ointment is used to treat first outbreaks of genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time) and to treat certain types of sores caused by the herpes simplex virus in people with weak immune systems. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body. Acyclovir does not cure col...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Acyclovir treats infections caused by herpes-family viruses. Oral forms treat shingles, genital herpes and chickenpox. Creams, ointments, the eye ointment, the buccal tablet and th...
  • As early as possible. For cold sores, that means at the first tingling, itching or burning. For genital herpes recurrences, start at the first sign of an outbreak. Early treatment...
  • The most common ones are headache, nausea and belly pain. Some people also get vomiting, dizziness or fatigue. These are usually manageable, but tell me if they bother you.
  • Call right away for confusion, hallucinations, seizures or unusual drowsiness. Also call if you urinate much less than usual, which can signal kidney trouble. Any allergic reaction...
📖 Read our full Acyclovir guide →
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 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 · Q2 2026 $13.26 $26.53 / 2 g
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 Per unit Per pack Marketing startMarketing endStatus
72578-0101-04 You're viewing this 1 TUBE in 1 CARTON / 2 g in 1 TUBE — — 2023-03-03 — Active
72578-0101-05 72578-101-05 Main listing 1 TUBE in 1 CARTON / 5 g in 1 TUBE $8.99 / g $44.96 2023-03-03 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 2 g in 1 tube.
What NDC number is used to bill for this package of Acyclovir 50 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acyclovir 50 mg/g 00591-1159-30 ACTAVIS 1 tube $0.315 AB Availability likely —
acyclovir 50 mg/g 72578-0082-01 Viona 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/g 70700-0107-15 Xiromed, 1 tube $0.522 AB Availability likely —
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.522 AB Availability likely —
acyclovir 50 mg/g 16714-0885-01 Northstar 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/g 65162-0835-94 Amneal 1 tube $0.522 AB Availability likely —
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.522 AB Availability likely —
acyclovir 50 mg/g 13668-0515-01 Torrent 15 g $0.522 AB Availability likely —
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed —
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $8.992 AB Availability likely —
Acyclovir 50 mg/g 45802-0044-75 Padagis 1 tube $8.992 AB Availability likely —
Acyclovir 50 mg/g 51672-1361-05 Sun 1 tube $8.992 AB Availability likely —
Acyclovir 50 mg/g 62332-0423-05 Alembic 1 tube $8.992 AB Availability likely —
Acyclovir 50 mg/g 65162-0836-14 Amneal 1 tube $8.992 AB Availability likely —
Zovirax 50 mg/g 00187-0994-45 Bausch 1 tube $38.247 AB FDA listed —
Acyclovir 50 mg/g 70771-1808-02 Zydus 1 tube — BX FDA listed —
Acyclovir 50 mg/g 72162-2327-02 Bryant 1 tube — AB FDA listed —
Acyclovir 50 mg/gthis 72578-0101-04 Viona 1 tube — BX FDA listed —
Zovirax 50 mg/g 00187-0993-95 Bausch 1 tube — AB FDA listed —
Acyclovir 50 mg/g 43547-0499-41 Solco 1 tube — — FDA listed —
acyclovir 50 mg/g 50090-6561-00 A-S 1 tube — AB FDA listed —
Acyclovir 50 mg/g 63629-2327-01 Bryant 30 g — AB FDA listed —
Acyclovir 50 mg/g 63629-2328-01 Bryant 15 g — AB FDA listed —
acyclovir 50 mg/g 70771-1371-01 Zydus 1 tube — AB FDA listed —
Acyclovir 50 mg/g 72162-1960-02 Bryant 15 g — AB FDA listed —
Acyclovir 50 mg/g 85957-0036-01 Aryeh 2 tubes — AB FDA listed —
acyclovir 50 mg/g 85766-0115-15 Sportpharm 1 tube — AB FDA listed —
acyclovir 50 mg/g 68071-3909-05 NuCare 1 tube — AB FDA listed —
acyclovir 50 mg/g 68788-8247-01 Preferred 1 tube — AB FDA listed —
acyclovir 50 mg/g 68788-4142-01 c 15 g — AB FDA listed —
acyclovir 50 mg/g 50090-8074-00 A-S 1 tube — AB FDA listed —
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
Mar 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.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • 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.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

7 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

LabelerViona Pharmaceuticals Inc
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA206770 (ANDA)
Labeler code72578
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio94 products on file

More NDCs from Viona Pharmaceuticals Inc labeler code 72578

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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE Acyclovir cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. ( 1 ) Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

⏱️ Dosage and Administration 81 words ▾

2 DOSAGE AND ADMINISTRATION Apply 5 times a day for 4 days. ( 2 ) Administer immediately following the onset of cold sore lesions. ( 2 ) Acyclovir cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis i.e., during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults.

💊 Dosage Forms and Strengths 30 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 50 mg (equivalent to 5% w/w) acyclovir ( 3 ) Each gram of acyclovir cream contains 50 mg (equivalent to 5% w/w) of acyclovir.

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir or any component of the formulation. ( 4 ) Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.

⚠️ Warnings and Cautions 146 words ▾

5 WARNINGS AND PRECAUTIONS Only for topical use of recurrent HSV lesions on the external aspect of lips and the face. Acyclovir cream should not be applied on mucous membranes including in the eye or inside the mouth or nose. ( 5.1 ) There is a potential for irritation and contact sensitization. ( 5.2 )

5.1General Acyclovir cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. Acyclovir cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose.

5.2Contact Sensitization Acyclovir cream has a potential for irritation and contact sensitization [ see Adverse Reactions ( 6.1 ) ]. The effect of acyclovir cream has not been established in immunocompromised patients.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions reported were local skin reactions at the application site. ( 6.1 ) Angioedema, anaphylaxis, contact dermatitis and eczema have been reported. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 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 clinical practice. In five double-blind, placebo-controlled trials, 1,124 patients were treated with acyclovir cream and 1,161 with placebo (vehicle) cream. Local application site reactions were reported by 5% of patients receiving acyclovir cream and 4% of patients receiving placebo.

The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving acyclovir cream and placebo. Three patients on acyclovir cream and one patient on placebo discontinued treatment due to an adverse event. An additional study, enrolling 22 healthy adults, was conducted to evaluate the dermal tolerance of acyclovir cream compared with vehicle using single occluded and semi-occluded patch testing methodology.

Both acyclovir cream and placebo showed a high and cumulative irritation potential. Another study, enrolling 251 healthy adults, was conducted to evaluate the contact sensitization potential of acyclovir cream using repeat insult patch testing methodology. Of 202 evaluable subjects, possible cutaneous sensitization reactions were observed in the same 4 (2%) subjects with both acyclovir cream and placebo, and these reactions to both acyclovir cream and placebo were confirmed in 3 subjects upon rechallenge.

The sensitizing ingredient(s) has not been identified. The safety profile in patients 12 to 17 years of age was similar to that observed in adults.

6.2Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of acyclovir cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to acyclovir cream.

General : Angioedema, anaphylaxis. Skin : Contact dermatitis, eczema.

🔄 Drug Interactions 70 words ▾

7 DRUG INTERACTIONS Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir cream. Due to minimal systemic absorption of acyclovir cream, systemic drug interactions are unlikely. ( 7 ) Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir cream.

Due to minimal systemic absorption of acyclovir cream, systemic drug interactions are unlikely.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the acyclovir cream [see Clinical Pharmacology ( 12.3 )]. Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes . Animal reproduction studies with systemic exposure of acyclovir have been conducted.

Refer to acyclovir prescribing information for additional details. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or 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% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and breastfeeding is not expected to result in exposure of the child to acyclovir cream [see Clinical Pharmacology ( 12.3 )]. There are no data on the effects of acyclovir on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for acyclovir cream and any potential adverse effects on the breastfed child from acyclovir cream or from the underlying maternal condition.

8.4Pediatric Use An open-label, uncontrolled trial with acyclovir cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.

8.5Geriatric Use Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal [ see Clinical Pharmacology ( 12.3 ) ].

🤰 Pregnancy 148 words ▾

8.1Pregnancy Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the acyclovir cream [see Clinical Pharmacology ( 12.3 )]. Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes . Animal reproduction studies with systemic exposure of acyclovir have been conducted.

Refer to acyclovir prescribing information for additional details. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or 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% to 4% and 15% to 20%, respectively.

🧒 Pediatric Use 71 words ▾

8.4Pediatric Use An open-label, uncontrolled trial with acyclovir cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.

🧓 Geriatric Use 61 words ▾

8.5Geriatric Use Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal [ see Clinical Pharmacology ( 12.3 ) ].

🆘 Overdosage 31 words ▾

10 OVERDOSAGE Overdosage by topical application of acyclovir cream is unlikely because of minimal systemic exposure [ see Clinical Pharmacology ( 12.3 ) ]. There is no information available for overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Acyclovir is an antiviral drug active against α-herpesviruses [ see Microbiology ( 12.4 ) ].

12.3Pharmacokinetics A clinical pharmacology study was performed with acyclovir cream in adult volunteers to evaluate the percutaneous absorption of acyclovir. In this study, which included 6 male volunteers, the cream was applied to an area of 710 cm 2 on the backs of the volunteers 5 times daily at intervals of 2 hours for a total of 4 days. The weight of cream applied and urinary excretion of acyclovir were measured daily.

Plasma concentration of acyclovir was assayed 1 hour after the final application. The average daily urinary excretion of acyclovir was approximately 0.04% of the daily applied dose. Plasma acyclovir concentrations were below the limit of detection (0.01 μM) in 5 subjects and barely detectable (0.014 μM) in 1 subject.

Systemic absorption of acyclovir from acyclovir cream is minimal in adults. The systemic absorption of acyclovir following topical application of cream has not been evaluated in patients <18 years of age.

12.4Microbiology Mechanism of Action: Acyclovir is a synthetic purine deoxynucleoside analogue with cell culture and in vivo inhibitory activity against HSV types 1 (HSV-1) and 2 (HSV-2) DNA polymerases. It inhibits HSV-1 and HSV-2 replication in cell culture and in vivo . The inhibitory activity of acyclovir is selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV.

This viral enzyme converts acyclovir into acyclovir monophosphate, a deoxynucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In biochemical assays, acyclovir triphosphate inhibits replication of α-herpes viral DNA.

This inhibition is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. Antiviral Activity The quantitative relationship between the susceptibility of herpes viruses to antivirals in cell culture and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (EC 50 ), vary greatly depending upon a number of factors.

Using plaque-reduction assays on Vero cells, the EC 50 values of acyclovir against herpes simplex virus isolates range from 0.09 to 59.9 μM (0.02 to 13.5 mcg/mL) for HSV-1 and from 0.04 to 44 μM (0.01 to 9.9 mcg/mL) for HSV-2. Resistance In Cell Culture Acyclovir-resistant HSV-1 and HSV-2 strains were isolated in cell culture. Acyclovir-resistant HSV resulted from mutations in the viral thymidine kinase (TK; pUL23) and DNA polymerase (POL; pUL30) genes.

Frameshifts were commonly isolated and result in premature truncation of the HSV TK product with consequent decreased susceptibility to acyclovir. Mutations in the viral TK gene may lead to complete loss of TK activity (TK negative), reduced levels of TK activity (TK partial), or alteration in the ability of viral TK to phosphorylate the drug without an equivalent loss in the ability to phosphorylate thymidine (TK altered). In cell culture the following resistance-associated substitutions in TK of HSV-1 and HSV-2 were observed (Table 1).

Table 1 Summary of Acyclovir (ACV) Resistance-associated Amino Acid Substitutions in Cell Culture HSV-1 TK P5A, H7Q, L50V, G56V, G59A, G61A, K62N, T63A, E83K, P84S, D116N, P131S, R163H, A167V, P173L, Q185R, R216S, R220H, T245M, R281stop, T287M, M322K HSV-2 TK L69P, C172R, T288M HSV-1 POL D368A, Y557S, E597D, V621S, L702H, N815S, V817M, G841C HSV-2 POL - In HSV-Infected Patients Clinical HSV-1 and HSV-2 isolates obtained from patients who failed treatment for their α-herpesvirus infections were evaluated for genotyp… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Acyclovir is an antiviral drug active against α-herpesviruses [ see Microbiology ( 12.4 ) ].

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Acyclovir cream, 5% is white to off white homogenous cream which contains 50 mg (equivalent to 5% w/w) acyclovir in an aqueous cream base. Acyclovir cream is supplied as follows: 2-g tubes (NDC 72578-101-04). 5-g tubes (NDC 72578-101-05). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature].

📋 Description 133 words ▾

11 DESCRIPTION Acyclovir is a synthetic deoxynucleoside analogue active against herpes viruses. Acyclovir cream 5% is a formulation for topical administration. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula: Acyclovir, USP is a white to off-white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.20.

The maximum solubility in water at 37°C is 2.5 mg/mL. It is soluble in diluted hydrochloric acid; slightly soluble in water; and insoluble in alcohol. The pKa's of acyclovir are 2.27 and 9.25.

Each gram of acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir, USP and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum. Acyclovir Cream

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). G eneral Patients should be informed that acyclovir cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. Acyclovir cream is not a cure for cold sores.

Patients should be instructed that acyclovir cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that acyclovir cream should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should be instructed to avoid applying other topical products to the affected area while using acyclovir cream.

Do not use if you are allergic to acyclovir cream or any of the ingredients in acyclovir cream. Before you use acyclovir cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. I nstructions for Use Treatment should be initiated at the earliest sign or symptom of recurrence.

Instruct patients to wash hands prior to application and ensure the face and/or lips are clean and dry. Advise patients to apply acyclovir cream topically 5 times per day for 4 days. Instruct patients to topically apply a quantity of acyclovir cream sufficient to cover the affected area, including the outer margin.

Advise patients to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Instruct patients to wash their hands with soap and water after using acyclovir cream. Keep out of reach of children.

Po ss ible Side Effects Common skin-related side effects that occurred when acyclovir cream was applied include application site reactions. Acyclovir cream has the potential for irritation and contact sensitization.

🍼 Nursing Mothers 89 words ▾

8.2Lactation Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and breastfeeding is not expected to result in exposure of the child to acyclovir cream [see Clinical Pharmacology ( 12.3 )]. There are no data on the effects of acyclovir on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for acyclovir cream and any potential adverse effects on the breastfed child from acyclovir cream or from the underlying maternal condition.

🧬 Pharmacokinetics 153 words ▾

12.3Pharmacokinetics A clinical pharmacology study was performed with acyclovir cream in adult volunteers to evaluate the percutaneous absorption of acyclovir. In this study, which included 6 male volunteers, the cream was applied to an area of 710 cm 2 on the backs of the volunteers 5 times daily at intervals of 2 hours for a total of 4 days. The weight of cream applied and urinary excretion of acyclovir were measured daily.

Plasma concentration of acyclovir was assayed 1 hour after the final application. The average daily urinary excretion of acyclovir was approximately 0.04% of the daily applied dose. Plasma acyclovir concentrations were below the limit of detection (0.01 μM) in 5 subjects and barely detectable (0.014 μM) in 1 subject.

Systemic absorption of acyclovir from acyclovir cream is minimal in adults. The systemic absorption of acyclovir following topical application of cream has not been evaluated in patients <18 years of age.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES

14.1Adult Subjects Acyclovir cream was evaluated in two double-blind, randomized, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis. The average patient had five episodes of herpes labialis in the previous 12 months. In the first trial, the median age of subjects was 37 years (range 18 to 81 years), 74% were female, and 94% were Caucasian.

In the second trial, median age of subjects was 38 years (range 18 to 87 years), 73% were female, and 94% were Caucasian. Subjects were instructed to initiate treatment within 1 hour of noticing signs or symptoms and continue treatment for 4 days, with application of study medication 5 times per day. In both studies, the mean duration of the recurrent herpes labialis episode was approximately one-half day shorter in the subjects treated with acyclovir cream (n = 682) compared with subjects treated with placebo (n = 703) for approximately 4.5 days versus 5 days, respectively.

No significant difference was observed between subjects receiving acyclovir cream or placebo in the prevention of progression of cold sore lesions.

14.2Pediatric Subjects An open-label, uncontrolled trial with acyclovir cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults.

🧪 Nonclinical Toxicology 77 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Systemic exposure following topical administration of acyclovir is minimal. Dermal carcinogenicity studies were not conducted. Results from the studies of carcinogenesis, mutagenesis and fertility are not included in the full prescribing information for acyclovir cream due to the minimal exposures of acyclovir that result from dermal application.

Information on these studies is available in the full prescribing information for acyclovir capsules, tablets, and suspension and acyclovir for injection.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Acyclovir ( ay sye' kloe vir) Cream Important information: Acyclovir cream is for use on cold sores on the lips and around the mouth only. Acyclovir cream should not be used in your eyes, mouth, nose, or on your genitals. What is acyclovir cream?

Acyclovir cream is a prescription medicine used to treat cold sores (herpes labialis) that are recurring in adults and children 12 years of age and older, and who have normal immune systems. Acyclovir cream is not a cure for cold sores. It is not known if acyclovir cream is safe and effective in children less than 12 years of age.

Do not use acyclovir cream if you are allergic to acyclovir, valacyclovir, or any of the ingredients in acyclovir cream. See the end of this leaflet for a complete list of ingredients in acyclovir cream. What should I tell my healthcare provider before using acyclovir cream?

Before using acyclovir cream, tell your healthcare provider about all of your medical conditions, including if you: become sick very easily (have a weak immune system). are pregnant or plan to become pregnant. It is not known if acyclovir cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if acyclovir passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby if you use acyclovir 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 acyclovir cream?

Use acyclovir cream exactly as your healthcare provider tells you to use it. Use acyclovir cream as soon as you have the first symptoms of a cold sore such as itching, redness, burning or tingling, or when the cold sore appears. Wash your hands with soap and water before and after applying acyclovir cream.

The affected area should be clean and dry before applying acyclovir cream. Apply acyclovir cream to the affected area 5 times each day for 4 days, including the outer edge. You should not apply other skin products to the affected area during treatment with acyclovir cream.

Avoid unnecessary rubbing of the cold sore because this may cause the cold sore to spread to other areas around your mouth or make your cold sore worse. What are the possible side effects of acyclovir cream? The most common side effects of acyclovir cream are skin reactions at the treatment site and may include: dry or cracked lips, peeling, flaking or dryness of the skin, a burning or stinging feeling, and itching.

These are not all the possible side effects of acyclovir 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 acyclovir cream? Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature]. Keep acyclovir cream and all medicines out of reach of children.

General information about the safe and effective use of acyclovir cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use acyclovir cream for a condition for which it was not prescribed.

Do not give acyclovir cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about acyclovir cream that is written for health professionals.

What are the ingredients in acyclovir cream? Active ingredient: acyclovir, USP Inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum. Manufactured by: Zydus Lifesciences Ltd.

Changodar, Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 For more information, call 1-888-304-5011.

Rev.:04/23 This Patient Information has been approved by the U.S. Food and Drug Administration.

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72578-101-04 in tube of 2 g Acyclovir Cream, 5% Rx only 2 g Acyclovir Cream Acyclovir Cream

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube72578-0101-05 3,233 Rx · $262,392
1 tube this page72578-0101-04 No Medicaid data
Drug total (last 4 qtrs): 3,233 Rx · 18,605 units · $262,392 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Acyclovir — the program that covers self-administered drugs. 29 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 Acyclovir. 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
$11.1M
Claims incl. refills
517.4K
Beneficiaries
366.8K
Spend / beneficiary
$30.28
Spend / claim
$21.46
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.

About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Viona Pharmaceuticals Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (72578-0101-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Viona Pharmaceuticals Inc 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.
← 72578-0100-01 · Viona 72578-0102-04 · Viona →
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.