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KeriCleanz ANTISEPTIC Hydrogen Peroxide 1 mL/100mL Spray, 28 mL — NDC 78280-0401-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

KeriCleanz ANTISEPTIC Hydrogen Peroxide 1 mL/100mL Spray, 28 mL — NDC 78280-401-10 (Billing 78280-0401-10)

by Kericure Inc. · 28 mL in 1 BOTTLE, SPRAY

This is a package of 28 mL of KeriCleanz ANTISEPTIC Hydrogen Peroxide 1 mL/100mL Spray from Kericure Inc., marketed since Oct 2023 and currently FDA-listed.

NDC 78280-0401-10
🏷️ FDA NDC (as labeled) 78280-401-10 billing pads the product segment with a zero
This package
Contains28 mL Pack sizes2 compare ↓
Product page 78280-0401-05 Also comes in: 17 ml 78280-401-05
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 78280-401-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
78280 labeler · 401 product · 10 package
Package marketed since
Oct 11, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7828040110 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 78280-401-10
Product NDC 78280-401
11-digit billing NDC 78280040110
UNII BBX060AN9V
Application # M003
SPL Set ID 79b0d9bb-0fa5-4e45-ab74-9ff0e1215238
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-11
Route TOPICAL
Dosage form SPRAY
Substance HYDROGEN PEROXIDE
Why two NDCs? The FDA registers this code as 78280-401-10 — 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 → 78280-0401-10. 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.

Clinical

🧪 What is this product?

KeriCleanz Antiseptic is a topical spray containing 1% hydrogen peroxide, marketed as an over-the-counter monograph product. Hydrogen peroxide is commonly used as an antiseptic and cleansing agent for minor cuts, scrapes, and wounds. When applied to the skin, it typically fizzes and helps remove debris and dead tissue from the affected area. This product is intended for external use only on the skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Hydrogen Peroxide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Hydrogen Peroxide (3 interactions) — ranked by severity →
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 mLPer 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.
Try another pack size: 17 ml
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
78280-0401-10 You're viewing this 28 mL in 1 BOTTLE, SPRAY 2023-10-11 — Active
78280-0401-05 78280-401-05 Main listing 17 mL in 1 BOTTLE, SPRAY 2025-08-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 28 mL — 28 ml in 1 bottle, spray.
How does this package differ from NDC 78280-0401-05?
Both are KeriCleanz ANTISEPTIC Hydrogen Peroxide 1 mL/100mL Spray — the drug itself is identical. This page's package is the 28 mL one, while NDC 78280-0401-05 is the 17 ml package.
What NDC number is used to bill for this package of KeriCleanz ANTISEPTIC Hydrogen Peroxide 1 mL/100mL Spray?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
KeriCleanz ANTISEPTIC 1 mL/100mLthis 78280-0401-10 Kericure 28 ml — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years 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.

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

  • UNII 3M4G523W1G
    Silver is a metallic element used in some medications as an antimicrobial agent in topical formulations. It helps prevent bacterial growth on wound dressings and certain skin preparations.
  • 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.

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

The official label also statesPurified water, silver hydrosol (10ppm)

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

LabelerKericure Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code78280
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Kericure Inc. labeler code 78280

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses: Antimicrobial skin cleanser helps reduce bacteria that potentially cause infection • For general skin & wound cleaning.

⏱️ Dosage and Administration 54 words ▾

Directions for Use: Gently invert bottle to evenly mix. Apply spray to skin or wound to fully cover area. Bubbling may occur as it cleanses wound. No rinsing required. Reapply as needed or as directed by a physician. Can be applied to gauze or dressings to pack into wounds. Stop use if condition worsens.

⚠️ Warnings 51 words ▾

Warnings: For external use only. Do not use in eyes. Do not ingest. Do not use if allergic to ingredients. Discontinue use if irritation, redness or pain develops. If condition persists, consult a doctor. Keep out of reach of children ; for children 2 and under consult a physician before use.

📦 Storage and Handling 9 words ▾

Other Information: Store at room temperature. Avoid direct sunlight.

🧪 Active Ingredient 6 words ▾

Active Ingredients Hydrogen Peroxide 1% (v/v)

🧪 Inactive Ingredients 7 words ▾

Inactive Ingredients: Purified water, silver hydrosol (10ppm)

🎯 Purpose 3 words ▾

Purpose Topical Antiseptic

📄 Keep Out of Reach of Children 17 words ▾

Keep out of reach of children ; for children 2 and under consult a physician before use.

📄 Questions or Comments 7 words ▾

Questions? [email protected] or visit us at www.KeriCure.com

📄 Package Label / Principal Display Panel 2 words ▾

Packaging KeriCleanz

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

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 KeriCleanz ANTISEPTIC (this brand).

Top reported reactions

Nausea23
Fatigue22
Vomiting17
Headache16
Rash16
Pruritus14
Shock Haemorrhagic14

Age at onset

Neonate1
Child2
Adolescent2
Adult36
Elderly17

Reporter sex

304 reports
Male · 49%
Female · 49%
Unknown · 2%

Serious outcomes

Hospitalization127
Death43
Life-threatening31
Disabling7
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 40 14
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.

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 Kericure Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 17 ml (78280-0401-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kericure 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.
← 78280-0304-02 · Kericure 78280-0703-01 · Kericure →
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.