Home › NDC Lookup › Ingredients › Acyclovir › 70700-0107-16
Acyclovir 50 mg/g Ointment — NDC 70700-0107-16 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 Ointment — NDC 70700-107-16 (Billing 70700-0107-16)

by Xiromed, LLC · 1 TUBE in 1 CARTON / 30 g in 1 TUBE

This is a package of Acyclovir 50 mg/g Ointment from Xiromed, LLC, marketed since Jan 2020 and currently FDA-listed; retail pharmacies pay about $0.3459 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 70700-0107-16
🏷️ FDA NDC (as labeled) 70700-107-16 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Cost per g$0.3459 NADAC Per package$10.38 / 30 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.9918/unit · Part D plans $1.40/unit — full pricing hub ↓
Main listing for product 70700-107 · Also comes in: 15 g 70700-107-15
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70700-107-16
Product NDC 70700-107
11-digit billing NDC 70700010716
NCPDP billing unit GM — per gram (weight)
RxCUI 197312
UNII X4HES1O11F
UPC 0370700107164
Application # ANDA201501
SPL Set ID 3e222423-3bf2-6584-6d54-447b1b26dc42
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 2020-01-30
Route TOPICAL
Dosage form OINTMENT
Substance ACYCLOVIR
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90350010004205
GPI class Acyclovir
GCN Seq No 007670
GCN 31640
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% OINTMENT
FDB brand name Acyclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007670
  • GCN: 31640
  • GPI-14 (Medi-Span): 90350010004205
  • HICL (First Databank): 004183
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 197312
Why two NDCs? The FDA registers this code as 70700-107-16 — 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 → 70700-0107-16. 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% OINTMENT Ingredient Acyclovir
📗 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 $0.346 $10.38 / 30 g
Medicaid paysCMS SDUD · 12 mo $0.9918 $29.75 / 30 g
Medicare drug plans payPart D · Q2 2026 $1.40 $41.99 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.176 $0.306
▼ Down 60% 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 Per unit Per pack Marketing startMarketing endStatus
70700-0107-15 70700-107-15 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.5221 / g $7.83 2020-01-30 — Active
70700-0107-16 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.3459 / g $10.38 2020-01-30 — Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.3459 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 60% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Acyclovir 50 mg/g Ointment?
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 save 9%
Acyclovir 50 mg/gthis 70700-0107-16 Xiromed, 1 tube $0.346 AB Availability likely —
acyclovir 50 mg/g 13668-0515-01 Torrent 15 g $0.522 AB Availability likely +51%
acyclovir 50 mg/g 16714-0885-01 Northstar 1 tube $0.522 AB Availability likely +51%
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.522 AB Availability likely +51%
Acyclovir 50 mg/g 65162-0835-94 Amneal 1 tube $0.522 AB Availability likely +51%
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.522 AB Availability likely +51%
acyclovir 50 mg/g 72578-0082-01 Viona 1 tube $0.522 AB Availability likely +51%
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed +95%
Acyclovir 50 mg/g 51672-1361-05 Sun 1 tube $8.992 AB Availability likely +2500%
Acyclovir 50 mg/g 62332-0423-05 Alembic 1 tube $8.992 AB Availability likely +2500%
Acyclovir 50 mg/g 65162-0836-14 Amneal 1 tube $8.992 AB Availability likely +2500%
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $8.992 AB Availability likely +2500%
Acyclovir 50 mg/g 45802-0044-75 Padagis 1 tube $8.992 AB Availability likely +2500%
Zovirax 50 mg/g 00187-0994-45 Bausch 1 tube $38.247 AB FDA listed +10959%
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 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 —
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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

1 inactive ingredient 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

LabelerXiromed, LLC
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA201501 (ANDA)
Labeler code70700
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio42 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

INDICATIONS AND USAGE Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV infections in immunocompromised patients.

⏱️ Dosage and Administration 93 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 USP, 5% 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 18 words ▾

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

⚠️ Warnings 19 words ▾

WARNINGS Acyclovir Ointment USP, 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 USP, 5% in the US, 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 Xiromed, LLC. at 844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 23 words ▾

Drug Interactions: Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Ointment USP, 5%.

🤰 Pregnancy 144 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B. Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women.

A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population.

However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 12 words ▾

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 58 words ▾

Geriatric Use: Clinical studies of Acyclovir Ointment USP, 5% 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 ).

🆘 Overdosage 21 words ▾

OVERDOSAGE Overdosage by topical application of Acyclovir Ointment USP, 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY ).

🧬 Clinical Pharmacology 198 words ▾

CLINICAL PHARMACOLOGY Two clinical pharmacology studies were performed with Acyclovir Ointment USP, 5% in immunocompromised 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 44 words ▾

HOW SUPPLIED Each gram of Acyclovir Ointment USP, 5% contains 50 mg acyclovir in a polyethylene glycol base. It is supplied as follows: 15 g tubes (NDC 70700-107-15) 30-g tubes (NDC 70700-107-16) Store at 15° to 25°C (59° to 77°F) in a dry place.

📦 Storage and Handling 12 words ▾

Store at 15° to 25°C (59° to 77°F) in a dry place.

📋 Description 98 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 USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base.

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.

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: Chemical Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General: The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION ). There are no data to support the use of Acyclovir Ointment USP, 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms. Acyclovir Ointment USP, 5% should not be used for the prevention of recurrent HSV infections.

Although clinically significant viral resistance associated with the use of Acyclovir Ointment USP, 5% has not been observed, this possibility exists. Drug Interactions: Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Ointment USP, 5%. Carcinogenesis, 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 Ointment USP, 5% 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.

Pregnancy: Teratogenic Effects: Pregnancy Category B. Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women.

A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population.

However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether topically applied acyclovir is excreted in breast milk.

Systemic exposure following topical administration is minimal. After oral administration of Acyclovir Ointment USP, 5%, acyclovir concentrations have been documented in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day.

Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing. Geriatric Use: Clinical studies of Acyclovir Ointment USP, 5% 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 ). Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

🍼 Nursing Mothers 84 words ▾

Nursing Mothers: It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal. After oral administration of Acyclovir Ointment USP, 5%, acyclovir concentrations have been documented in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding plasma levels.

These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day. Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing.

🔬 Clinical Studies 91 words ▾

CLINICAL TRIALS In clinical trials of initial genital herpes infections, Acyclovir Ointment USP, 5% has shown a decrease in healing time and, in some cases, a decrease in duration of viral shedding and duration of pain. In studies in immunocompromised patients primarily with herpes labialis, there was a decrease in duration of viral shedding and a slight decrease in duration of pain. In studies of recurrent genital herpes and of herpes labialis in nonimmunocompromised patients, there was no evidence of clinical benefit; there was some decrease in duration of viral shedding.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 75 words ▾

Carcinogenesis, 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 Ointment USP, 5% 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.

📄 Package Label / Principal Display Panel 88 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION ACYCLOVIR OINTMENT USP, 5% Manufactured for Xiromed, LLC, Florham Park, NJ 07932 Made in Spain NDC 70700-107-15 Each gram contains acyclovir 50 mg in a polyethylene glycol base. 15 g R x only

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton ACYCLOVIR OINTMENT USP, 5% Manufactured for Xiromed, LLC, Florham Park, NJ 07932 Made in Spain NDC 70700-107-16 Each gram contains acyclovir 50 mg in a polyethylene glycol base. 30 g R x only PRINCIPAL DISPLAY PANEL - 30 g Tube 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 this package alone, 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 – Q1 2026 · 5 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
1.6K
Units reimbursed last 4 qtrs
51.3K
Gross reimbursed last 4 qtrs
$50.9K
Avg / prescription
$31.19
Avg / unit
$0.9918
Latest quarter Q1 2026
63Rx
Medicaid pays / g
$0.9918
gross reimbursed
vs
NADAC / g
$0.3459
acquisition cost
=
Spread
+$0.6459
+187% 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 ⓘ
71% FFS 29% MCO
Fee-for-service · 1,155 Rx Managed care · 478 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: no data reported MI New York: 420 units · 2.1 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: no data reported IN Ohio: no data reported OH Pennsylvania: 330 units · 2.5 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 35,625 units · 91.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 360 units · 8.0 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported 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: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,170 units · 25.6 per 100k residents LA Mississippi: no data reported MS Alabama: 720 units · 14.1 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 510 units · 1.7 per 100k residents TX Florida: 12,210 units · 54.0 per 100k residents FL
Units reimbursed · per 100k residents
1.791.4
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 California 91.4 /100k
2 Florida 54.0 /100k
3 Louisiana 25.6 /100k
4 Alabama 14.1 /100k
5 Kentucky 8.0 /100k
6 Pennsylvania 2.5 /100k
7 New York 2.1 /100k
8 Texas 1.7 /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.

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 tube this page70700-0107-16 1,633 Rx · $50,926
1 tube70700-0107-15 1,074 Rx · $23,923
Drug total (last 4 qtrs): 2,707 Rx · 68,925 units · $74,849 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.
← 70700-0106-15 · Xiromed, 70700-0109-15 · Xiromed, →
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.