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Peroxyl Mouth Sore Mild Mint Hydrogen Peroxide 15 mg/mL Rinse, 250 mL — NDC 00126-0083-99 package photo

Peroxyl Mouth Sore Mild Mint Hydrogen Peroxide 15 mg/mL Rinse, 250 mL

by Colgate Oral Pharmaceuticals Inc. · 250 mL in 1 BOTTLE, PLASTIC (0126-0083-99)
NDC 00126-0083-99
🏷️ FDA NDC (as labeled) 0126-0083-99 billing pads the labeler segment with a zero
This package
Contains250 mL Pack sizes5 compare ↓
Also comes in: 50 pouches 00126-0083-70 500 ml 00126-0083-16 946 ml 00126-0083-31 1000 ml 00126-0083-22
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0126-0083-99
Product NDC 0126-0083
11-digit billing NDC 00126008399
RxCUI 358975, 1727009
UNII BBX060AN9V
UPC 0035000320292
Application # M022
SPL Set ID b1e1b7c9-dea7-4d64-b6a8-5343f4176359
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-01-01
Route BUCCAL
Dosage form RINSE
Substance HYDROGEN PEROXIDE
Why two NDCs? The FDA registers this code as 0126-0083-99 — a 4-4-2 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 labeler segment → 00126-0083-99. 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

LabelerColgate Oral Pharmaceuticals Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00126
First marketedJan 2009
Product typeHuman Otc Drug
Portfolio4 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?

Peroxyl Mouth Sore is an over-the-counter rinse containing hydrogen peroxide that is applied to the inside of the mouth. Hydrogen peroxide is commonly used in oral rinses as an antimicrobial and cleansing agent. This product is marketed as an OTC monograph drug, meaning it follows the FDA's established category rules for oral hydrogen peroxide rinses rather than undergoing individual product approval.

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.

💊 What it looks like

Color Blue
FlavorMint
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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII F75JV2T505
    A synthetic polymer made from ethylene oxide and propylene oxide. It acts as a solubilizer and emulsifier to help mix oil and water-based ingredients, ensuring the medicine disperses evenly throughout the formulation.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 stateswater, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, FD&C blue no. 1

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.

💲 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 eachPer 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: 50 pouches 500 ml 946 ml 1000 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Peroxyl Mouth Sore Mild Mint 15 mg/mLthis 00126-0083-99 Colgate 250 ml — — FDA listed —
Sore Mouth Cleanser 15 mg/mL 00363-0085-34 Walgreen 236 ml — — FDA listed —
Sore Mouth Cleanser 15 mg/mL 41250-0750-34 Meijer, 236 ml — — Discontinued —
Medline Peroxi Fresh Mouthwash 15 mg/mL 53329-0086-14 Medline 59 ml — — FDA listed —
Perox-A-Mint Solution 15 mg/mL 53462-0075-30 Sage 44 ml — — FDA listed —
CloSYS 1.5 g/100mL 58578-0613-01 Rowpar 473 ml — — FDA listed —
GuruNanda Oxyfusion 15 mg/mL 70708-0010-16 GURUNANDA, 473 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

🏛️
2009
On the market since
Jan 2009
📍
2026
Currently FDA-listed
17 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00126-0083-16 500 mL in 1 BOTTLE, PLASTIC (0126-0083-16) 2009-01-01 Active
00126-0083-22 1000 mL in 1 BOTTLE (0126-0083-22) 2020-08-31 Active
00126-0083-31 946 mL in 1 BOTTLE (0126-0083-31) 2020-08-29 Discontinued by firm
00126-0083-70 50 POUCH in 1 CARTON (0126-0083-70) / 10 mL in 1 POUCH 2017-03-15 Active
00126-0083-99 You're viewing this 250 mL in 1 BOTTLE, PLASTIC (0126-0083-99) 2015-01-01 Active

Pack size FAQ

What quantity is in NDC 00126-0083-99?
NDC 00126-0083-99 contains 250 mL — 250 ml in 1 bottle, plastic.
What is the difference between NDC 00126-0083-99 and NDC 00126-0083-16?
Both are Peroxyl Mouth Sore Mild Mint Hydrogen Peroxide 15 mg/mL Rinse — the drug itself is identical. NDC 00126-0083-99 is the 250 mL package, while NDC 00126-0083-16 is the 500 ml package.
What NDC number is used to bill for this package of Peroxyl Mouth Sore Mild Mint Hydrogen Peroxide 15 mg/mL Rinse?
Bill NDC 00126-0083-99 — the 11-digit billing format is 00126008399. 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

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 0126-0083-99, 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: 00126-0083-99, written without dashes as 00126008399. 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 00126-0083-99, the first segment (00126) is the labeler code FDA assigned to Colgate Oral Pharmaceuticals Inc.; the middle segment (0083) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) 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 Colgate Oral Pharmaceuticals 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 4 other package presentations of this same product, including 50 pouches (00126-0083-70), 500 ml (00126-0083-16), 946 ml (00126-0083-31). 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?
Colgate Oral Pharmaceuticals 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.

📄 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
🎯 Indications and Usage 33 words ▾

Uses for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums

⏱️ Dosage and Administration 79 words ▾

Directions Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) around in the mouth over affected area for at least 1 minute, then spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children under 12 years of age should be supervised in the use of the product Children under 2 years of age: consult a dentist or physician

⚠️ Warnings 79 words ▾

Warnings Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow. Stop use and ask a doctor if sore mouth symptoms do not improve within 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other Information store at controlled room temperature 68 – 77° F (20 – 25°C)

🧪 Active Ingredient 6 words ▾

Active ingredient Hydrogen peroxide 1.5% (w/v)

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, FD&C blue no. 1

🎯 Purpose 6 words ▾

Purposes Oral debriding agent/oral wound cleanser

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00126-0074-92 · Colgate 00126-0084-01 · Colgate →
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.