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Zilactin Early Relief Cold Sore benzyl alcohol .1 g/g Gel — NDC 42829-0468-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zilactin Early Relief Cold Sore benzyl alcohol .1 g/g Gel — NDC 42829-468-02 (Billing 42829-0468-02)

by ASCENT CONSUMER PRODUCTS, INC · 1 TUBE in 1 CARTON / 7 g in 1 TUBE

This is a package of Zilactin Early Relief Cold Sore benzyl alcohol .1 g/g Gel from ASCENT CONSUMER PRODUCTS, INC, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 42829-0468-02
🏷️ FDA NDC (as labeled) 42829-468-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 42829-468-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
42829 labeler · 468 product · 02 package
Package marketed since
Nov 6, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4282946802 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42829-468-02
Product NDC 42829-468
11-digit billing NDC 42829046802
RxCUI 581456, 866357
UNII LKG8494WBH
Application # M022
SPL Set ID 42ef8bfa-c4d9-01cf-e063-6394a90ac88a
Established class (EPC) Pediculicide
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-06
Route TOPICAL
Dosage form GEL
Substance BENZYL ALCOHOL
Quick answers
  • RxCUI (RxNorm): 581456
Why two NDCs? The FDA registers this code as 42829-468-02 — 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 → 42829-0468-02. 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 Pediculicide class.

Pharmacologic class Pediculicide
Drug family (ATC) Other ectoparasiticides, incl. scabicides
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

📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves pain from cold sores, fever blisters, canker sores, mouth sores and gum irritation. It eases the pain while the sore is there.
  • Dry the sore first. Then dab it on with a cotton swab or clean finger. You can use it up to 4 times a day, and it should dry in about 30 to 60 seconds.
  • Children 2 and older can use it, and children under 12 should have an adult supervise. Do not use it in children under 2 unless a physician or dentist says so.
  • Do not use it for more than 7 days unless a physician or dentist directs you to. If the sore has not improved by then, it is time to get it checked.
📖 Read our full Benzyl Alcohol Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
42829-0468-02 You're viewing this Main listing 1 TUBE in 1 CARTON / 7 g in 1 TUBE 2025-11-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zilactin Early Relief Cold Sore .1 g/gthis 42829-0468-02 ASCENT 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🧪 Avoiding an ingredient? See Benzyl Alcohol Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII U3JF91U133
    Hydroxypropyl cellulose is a plant-derived polymer that acts as a binder, thickener, and film-former in medications. It helps hold tablet ingredients together, control how quickly the drug dissolves, and create protective coatings on pills.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • UNII 28F9E0DJY6
    Tannic acid is a plant-derived compound that acts as an astringent and antioxidant in medications. It's used to help bind ingredients together, preserve the product, and reduce moisture absorption in solid dosage forms.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesboric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, tannic acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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

LabelerASCENT CONSUMER PRODUCTS, INC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code42829
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio8 products on file

More NDCs from ASCENT CONSUMER PRODUCTS, INC labeler code 42829

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use temporarily relieves pain caused by: cold sores/fever blisters canker sores, mouth sores gum irritations

⏱️ Dosage and Administration 55 words ▾

Directions adults and children 2 years and older dry affected area. Apply with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. children under 12 years adult supervision should be given in the use of this product children under 2 years do not use, consult a physician or dentist

⚠️ Warnings 98 words ▾

Warnings Flammable: keep away from fire or flame Stop use and ask a physician if sore mouth symptoms do not improve in 7 days condition worsens or symptoms clear up and occur again within a few days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzyl alcohol 10%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, tannic acid

🎯 Purpose 8 words ▾

Purpose Cold sore/fever blister treatment, Oral pain reliever

📄 Stop Use and Ask a Doctor If 71 words ▾

Stop use and ask a physician if sore mouth symptoms do not improve in 7 days condition worsens or symptoms clear up and occur again within a few days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.

📄 Questions or Comments 2 words ▾

Call 1-888-547-5492

📄 Package Label / Principal Display Panel 1 words ▾

z

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

About this NDC listing & data coverage

Over-the-counter (OTC) 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ASCENT CONSUMER PRODUCTS, INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ASCENT CONSUMER PRODUCTS, INC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 42829-0408-60 · ASCENT 42829-0504-45 · ASCENT →
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.