HomeNDC LookupIngredientsAcyclovir › 43547-0499-42
ACYCLOVIR 50 mg/g Ointment — NDC 43547-0499-42 package photo

ACYCLOVIR 50 mg/g Ointment

by Solco Healthcare US, LLC · 1 TUBE in 1 CARTON (43547-499-42) / 15 g in 1 TUBE
NDC 43547-0499-42
🏷️ FDA NDC (as labeled) 43547-499-42 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $1.40/unit — full pricing hub ↓
Also comes in: 30 g 43547-0499-41
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 43547-499-42
Product NDC 43547-499
11-digit billing NDC 43547049942
RxCUI 197312
UNII X4HES1O11F
Application # ANDA212202
SPL Set ID a1d7b8ec-309d-447e-ae05-b9e89cc29948
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 2021-11-15
Route TOPICAL
Dosage form OINTMENT
Substance ACYCLOVIR
Why two NDCs? The FDA registers this code as 43547-499-42 — 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 → 43547-0499-42. 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.

🏭 Manufacturer & labeler

LabelerSolco Healthcare US, LLC
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA212202 (ANDA)
Labeler code43547
First marketedNov 2021
Product typeHuman Prescription Drug
Portfolio134 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.

🩺 Clinical

📖 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 doesn't cure herpes — it can't eliminate the virus from your body. What it does is slow down the virus's ability to copy itself, which shortens outbreaks, eases symptoms,...
  • What exactly does acyclovir do — does it cure herpes?
  • Timing really does matter with acyclovir. For cold sores, you want to start at the very first warning sign — that tingling or itching feeling — before a sore even appears. For geni...
  • How soon do I need to start taking it for it to work?
📖 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.

💊 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 OJ4Z5Z32L4
    A synthetic polymer made by linking ethylene glycol units together. It serves as a solvent, humectant to retain moisture, and film-forming agent in tablets and coatings to improve texture and drug delivery.
  • UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.

2 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 DailyMedingredient 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.

💲 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 $1.40 $21.00 / 15 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.

🔁 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 13668-0515-01 Torrent 15 g $0.536 AB Availability likely
acyclovir 50 mg/g 16714-0885-01 Northstar 1 tube $0.536 AB Availability likely
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.536 AB Availability likely
Acyclovir 50 mg/g 65162-0835-94 Amneal 1 tube $0.536 AB Availability likely
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.536 AB Availability likely
Acyclovir 50 mg/g 70700-0107-15 Xiromed, 1 tube $0.536 AB Availability likely
acyclovir 50 mg/g 72578-0082-01 Viona 1 tube $0.536 AB Availability likely
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed
Acyclovir 50 mg/g 51672-1361-05 Sun 1 tube $9.108 AB Availability likely
Acyclovir 50 mg/g 62332-0423-05 Alembic 1 tube $9.108 AB Availability likely
Acyclovir 50 mg/g 65162-0836-14 Amneal 1 tube $9.108 AB Availability likely
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $9.108 AB Availability likely
Acyclovir 50 mg/g 45802-0044-75 Padagis 1 tube $9.108 AB Availability likely
Zovirax 50 mg/g 00187-0994-45 Bausch 1 tube $38.247 AB FDA listed
Zovirax 50 mg/g 00187-0993-95 Bausch 1 tube AB FDA listed
Acyclovir 50 mg/gthis 43547-0499-42 Solco 1 tube FDA listed
acyclovir 50 mg/g 50090-6561-00 A-S 1 tube AB FDA listed
Acyclovir 50 mg/g 62332-0248-05 Alembic 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 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 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 85766-0115-15 Sportpharm 1 tube AB FDA listed
Acyclovir 50 mg/g 85957-0036-01 Aryeh 2 tubes AB FDA listed
Acyclovir 50 mg/g 72162-2327-02 Bryant 1 tube AB FDA listed
Acyclovir 50 mg/g 70771-1808-02 Zydus 1 tube BX FDA listed
Acyclovir 50 mg/g 72578-0101-04 Viona 1 tube BX FDA listed
acyclovir 50 mg/g 68788-4142-01 c 15 g 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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acyclovir — the ingredient across all brands.

Top reported reactions

Fatigue8,029
Diarrhoea7,348
Pneumonia5,700
Nausea5,643
Pyrexia4,989
Death4,896
Rash4,296

Age at onset

Neonate121
Infant157
Child436
Adolescent193
Adult8,482
Elderly12,300

Reporter sex

114,761 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization42,634
Life-threatening6,235
Disabling1,985
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 8,378 3,543
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43547-0499-41 1 TUBE in 1 CARTON (43547-499-41) / 30 g in 1 TUBE 2021-11-15 Active
43547-0499-42 You're viewing this 1 TUBE in 1 CARTON (43547-499-42) / 15 g in 1 TUBE 2021-11-15 Active

Pack size FAQ

What quantity is in NDC 43547-0499-42?
NDC 43547-0499-42 is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of ACYCLOVIR 50 mg/g Ointment?
Bill NDC 43547-0499-42 — the 11-digit billing format is 43547049942. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 43547-499-42, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43547-0499-42, written without dashes as 43547049942. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43547-0499-42, the first segment (43547) is the labeler code FDA assigned to Solco Healthcare US, LLC; the middle segment (0499) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (42) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Solco Healthcare US, LLC. 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 (43547-0499-41). 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?
Solco Healthcare US, LLC 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 26 words

INDICATIONS AND USAGE Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited nonlifethreatening mucocutaneous HSV infections in immune compromised patients.

⏱️ Dosage and Administration 91 words

DOSAGE AND ADMINISTRATION Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying acyclovir ointment to prevent autoinoculation of other body sites and transmission of infection to other persons.

Therapy should be initiated as early as possible following onset of signs and symptoms.

Contraindications 17 words

CONTRAINDICATIONS Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.

⚠️ Warnings 18 words

WARNINGS Acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.

🤒 Adverse Reactions 170 words

ADVERSE REACTIONS In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.

Observed During Clinical Practice: Based on clinical practice experience in patients treated with acyclovir ointment in the U.S., spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process.

Voluntary reports of adverse events that have been received since market introduction include: General: Edema and/or pain at the application site. Skin: Pruritus, rash. To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 Overdosage 20 words

OVERDOSAGE Overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY ).

🧬 Clinical Pharmacology 199 words

CLINICAL PHARMACOLOGY Two clinical pharmacology studies were performed with acyclovir ointment 5% in immune compromised adults at risk of developing mucocutaneous HSV infections or with localized varicella-zoster infections. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. In one of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches.

No local intolerance, systemic toxicity, or contact dermatitis were observed. In addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/mL). The other study included 11 patients with localized varicella zoster infections.

In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. Acyclovir levels in plasma ranged from <0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from <0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir excreted in the urine ranged from <0.02% to 9.4% of the daily dose.

Therefore, systemic absorption of acyclovir after topical application is minimal.

📦 How Supplied / Storage and Handling 98 words

HOW SUPPLIED Each gram of acyclovir ointment, USP 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. Acyclovir ointment, USP 5% is a white to off white ointment, free of foreign matters, free of lumps, translucent, homogeneous, and no phase separation. It is supplied as follows: 15 g tubes NDC 43547-499-42 30 g tubes NDC 43547-499-41 Store at 15° to 25°C (59° to 77°F) in a dry place.

Manufactured by: UBI Pharma Inc. No. 45, Guangfu N.

Rd., Hukou, Hsinchu 30351, Taiwan (TWN) Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2019 L187-01

📋 Description 100 words

DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base.

Acyclovir 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. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25.

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: structural formula

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