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Acyclovir 50 mg/g Cream — NDC 45802-044-75 (Billing 45802-0044-75) · Product 45802-044

by Padagis Israel Pharmaceuticals Ltd · 1 TUBE in 1 CARTON (45802-044-75) / 5 g in 1 TUBE

NDC 45802-044-75 (billing 45802-0044-75) is a package of Acyclovir 50 mg/g Cream from Padagis Israel Pharmaceuticals Ltd, marketed since Feb 2019 and currently FDA-listed; retail pharmacies pay about $8.99 per g (NADAC). It is the main listing for product NDC 45802-044, its only package size.

NDC 45802-0044-75
🏷️ FDA NDC (as labeled) 45802-044-75 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-044-75
Product NDC 45802-044
11-digit billing NDC 45802004475
NCPDP billing unit GM — per gram (weight)
RxCUI 141859
UNII X4HES1O11F
Application # ANDA208702
SPL Set ID 63fadf54-e8a3-4512-8a05-d64b998f5a08
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 2019-02-11
Route TOPICAL
Dosage form CREAM
Substance ACYCLOVIR
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90350010003720
GPI class Acyclovir
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 for NDC 45802-044-75
  • 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
  • 11-digit billing NDC: 45802004475
Why two NDCs? The FDA registers this code as 45802-044-75 — 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 → 45802-0044-75. 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 $8.992 $44.96 / 5 g
Medicaid paysCMS SDUD · 12 mo $14.27 $71.35 / 5 g
Medicare drug plans payPart D · Q2 2026 $13.26 $66.32 / 5 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $54.925 $8.992
▼ Down 84% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
45802-0044-75 45802-044-75 You're viewing this Main listing 1 TUBE in 1 CARTON (45802-044-75) / 5 g in 1 TUBE 2019-02-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acyclovir 50 mg/g 00591-1159-30 ACTAVIS 1 tube $0.315 AB Availability likely save 96%
acyclovir 50 mg/g 72578-0082-01 Viona 1 tube $0.522 AB Availability likely save 94%
Acyclovir 50 mg/g 70700-0107-15 Xiromed, 1 tube $0.522 AB Availability likely save 94%
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.522 AB Availability likely save 94%
acyclovir 50 mg/g 16714-0885-01 Northstar 1 tube $0.522 AB Availability likely save 94%
Acyclovir 50 mg/g 65162-0835-94 Amneal 1 tube $0.522 AB Availability likely save 94%
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.522 AB Availability likely save 94%
acyclovir 50 mg/g 13668-0515-01 Torrent 15 g $0.522 AB Availability likely save 94%
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed save 92%
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $8.992 AB Availability likely —
Acyclovir 50 mg/gthis 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 +325%
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/g 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

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA208702 (ANDA)
Labeler code45802
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio175 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ 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 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 75 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. 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 )

⏱️ Dosage and Administration 83 words ▾

2 DOSAGE AND ADMINISTRATION 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. • Apply 5 times a day for 4 days. ( 2 ) • Administer immediately following the onset of cold sore lesions. ( 2 )

💊 Dosage Forms and Strengths 31 words ▾

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

⛔ Contraindications 42 words ▾

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

⚠️ Warnings and Cautions 148 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 Padagis ® at 1-866-634-9120 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, 1124 patients were treated with acyclovir cream and 1161 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 71 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. • 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 )

👥 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 149 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 deoxynucleoside 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 value), 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 μg/mL) for HSV-1 and from 0.04 to 44.0 μM (0.01 to 9.9 μg/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 g… [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 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Acyclovir cream is a white, odorless, smooth homogeneous cream. Each gram of acyclovir cream contains 50 mg (equivalent to 5% w/w) of acyclovir in an aqueous cream base. Acyclovir cream, 5% is supplied as follows: • 5 g tubes NDC 45802-044-75 Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 114 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 is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.

The maximum solubility in water at 37°C is 2.5 mg/mL. 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 and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water and white petrolatum.

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). General 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. Instructions 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.

Possible 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. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-24 7G800 RC PH4

🧬 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

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 PATIENT INFORMATION Acyclovir (ay-SYE-kloe-vir) Cream, 5% 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.

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. 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.

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 acyclovir cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep acyclovir cream and all medicines out of the reach of children. General information about the safe and effective use… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 27 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 45802-044-75 Rx Only Acyclovir Cream, 5% Each gram contains 50 mg acyclovir. USE ONLY FOR COLD SORES. 5 g Acyclovir Cream carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 45802-0044-75, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.8K
Units reimbursed last 4 qtrs
22.8K
Gross reimbursed last 4 qtrs
$325.9K
Avg / prescription
$86.69
Avg / unit
$14.2705
Latest quarter Q4 2025
1.2KRx
Medicaid pays / g
$14.2705
gross reimbursed
vs
NADAC / g
$8.9916
acquisition cost
=
Spread
+$5.2789
+59% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
67% FFS 33% MCO
Fee-for-service · 2,524 Rx Managed care · 1,236 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 755 units · 7.5 per 100k residents MI New York: 10,265 units · 52.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 205 units · 3.0 per 100k residents IN Ohio: 1,355 units · 11.5 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 420 units · 6.0 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,690 units · 37.3 per 100k residents KY West Virginia: no data reported WV Virginia: 580 units · 6.7 per 100k residents VA Maryland: no data reported MD Connecticut: 3,790 units · 105 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 635 units · 5.9 per 100k residents NC South Carolina: 1,220 units · 22.7 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 330 units · 6.5 per 100k residents AL Georgia: 595 units · 5.4 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 60 units · 0.2 per 100k residents TX Florida: 940 units · 4.2 per 100k residents FL
Units reimbursed · per 100k residents
0.2105
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 105 /100k
2 New York 52.5 /100k
3 Kentucky 37.3 /100k
4 South Carolina 22.7 /100k
5 Ohio 11.5 /100k
6 Michigan 7.5 /100k
7 Virginia 6.7 /100k
8 Alabama 6.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for 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.
← 45802-0042-01 · Padagis 45802-0045-01 · Padagis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.