HomeNDC LookupIngredientsHydrogen Peroxide › 42961-0216-01
Xpect Hydrogen Peroxide 3 mL/100mL Spray, 59.1 mL — NDC 42961-0216-01 package photo

Xpect Hydrogen Peroxide 3 mL/100mL Spray, 59.1 mL

by Cintas Corporation · 59.1 mL in 1 BOTTLE, SPRAY (42961-216-01)
NDC 42961-0216-01
🏷️ FDA NDC (as labeled) 42961-216-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Hydrogen Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 7, 2025 — Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol (Consumer Product Partners, LLC) · FDA recall D-0302-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 42961-216-01
Product NDC 42961-216
11-digit billing NDC 42961021601
RxCUI 283420
UNII BBX060AN9V
Application # M003
SPL Set ID 793afae4-5270-4be7-b41a-269b4e59bcad
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-16
Route TOPICAL
Dosage form SPRAY
Substance HYDROGEN PEROXIDE
Why two NDCs? The FDA registers this code as 42961-216-01 — 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 → 42961-0216-01. 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 Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Other antiseptics and disinfectants, Other dermatologicals
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

LabelerCintas Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code42961
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio30 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 is this product?

This is a topical spray solution containing 3 percent hydrogen peroxide, marketed as an over-the-counter monograph drug. Hydrogen peroxide is commonly used as an antiseptic and cleansing agent for minor wounds, cuts, and scrapes. When applied to affected areas, it typically helps remove debris and may produce a foaming action. 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:

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.

🧪 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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statespurified water

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 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 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.
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
First Aid Only Hydrogen Peroxide 3% 30 mg/mL 00924-0935-01 Acme 59.1 ml FDA listed
Hydrogen Peroxide 30 mg/mL 11344-0871-34 Nice-Pak 237 ml FDA listed
Xpect Hydrogen Peroxide 3 mL/100mLthis 42961-0216-01 Cintas 59.1 ml FDA listed
MediFirst Hydrogen Peroxide 43.275 g/L 47682-0257-02 Unifirst 0591 l FDA listed
Hydrogen Peroxide 30 mL/L 47682-0304-02 Unifirst 0591 l FDA listed
Green Guard Hydrogen Peroxide 30 mL/L 47682-0324-02 Unifirst 0591 l FDA listed
Green Guard Hydrogen Peroxide 30 mL/L 47682-0334-02 Unifirst 0591 l FDA listed
Hydrogen Peroxide 30 mg/mL 50332-0219-02 HART 60 ml FDA listed
Hydrogen Peroxide 30 mg/mL 50332-0229-02 HART 60 ml FDA listed
Hydrogen Peroxide 30 mg/mL 50804-0871-34 Perrigo 236 ml FDA listed
American Red Cross 6oz, 3% Hydrogen Peroxide 5.31 mL/177mL 51628-3775-01 MY 177 ml FDA listed
American Red Cross 3 Hydrogen Peroxide 30 mg/mL 51628-4238-01 MY 177 ml FDA listed
Water Jel Hydrogen Peroxide 3 mL/100mL 59898-0403-10 Water-Jel 59 ml FDA listed
Hydrogen Peroxide 30 mg/mL 61010-5400-02 Safetec 59.1 ml FDA listed
Hydrogen Peroxide 30 mL/L 69396-0108-02 Trifecta 059 l FDA listed
American Safety First Aid Antispetic 30 mL/1000mL 71927-0013-01 Orazen 59.1 ml FDA listed
Hydrogen Peroxide 30 mg/mL 73598-0661-01 JHK 59.1 ml FDA listed
MEDI-FIRST First Aid Antiseptic 30 mL/L 78495-0162-01 Ultra 0591 l FDA listed
Biopure 3 Hydrogen Peroxide 30 mg/mL 78691-0021-50 Quest 177 ml FDA listed
Hydrogen Peroxide 30 mg/mL 84269-3503-01 Wildman 59.1 ml FDA listed
Oopsie 3 Hydrogen Peroxide 30 mg/mL 87251-0006-06 4 177 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.

🔬 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 Hydrogen Peroxide — the ingredient across all brands.

Top reported reactions

Nausea24
Fatigue23
Pruritus17
Vomiting17
Headache16
Rash16
Shock Haemorrhagic14

Age at onset

Neonate1
Child2
Adolescent3
Adult36
Elderly17

Reporter sex

0 reports

Serious outcomes

Hospitalization133
Life-threatening35
Disabling12
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42961-0216-01 You're viewing this 59.1 mL in 1 BOTTLE, SPRAY (42961-216-01) 2022-05-16 Active

🧭 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 FDA registers it as 42961-216-01, 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: 42961-0216-01, written without dashes as 42961021601. 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 42961-0216-01, the first segment (42961) is the labeler code FDA assigned to Cintas Corporation; the middle segment (0216) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Cintas Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cintas Corporation 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.

📄 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 13 words

Uses first aid to help prevent infection in minor cuts, scrapes and burns

⏱️ Dosage and Administration 26 words

Directions clean the affected area spray a small amount 1 to 3 times daily may be covered with a sterile bandage. if bandaged, let dry first

⚠️ Warnings 5 words

Warnings For external use only

📦 Storage and Handling 6 words

Other information store at room temperature

🧪 Active Ingredient 8 words

Active ingredients Hydrogen Peroxide topical solution U.S.P. 3%

🧪 Inactive Ingredients 4 words

Inactive Ingredients purified water

🎯 Purpose 4 words

Purpose First Aid Antiseptic

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.