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Gly-Oxide Carbamide Peroxide 100 mg/mL Liquid — NDC 63029-0500-01 package photo

Gly-Oxide Carbamide Peroxide 100 mg/mL Liquid

by Medtech Products Inc. · 1 BOTTLE in 1 CARTON (63029-500-01) / 15 mL in 1 BOTTLE
NDC 63029-0500-01
🏷️ FDA NDC (as labeled) 63029-500-01 billing pads the product segment with a zero
This package
Contains15 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 60 mL 63029-0500-02
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

⚠️
Other active recalls for Carbamide Peroxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0680-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0679-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0685-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0683-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0688-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0687-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63029-500-01
Product NDC 63029-500
11-digit billing NDC 63029050001
NCPDP billing unit ML — per mL (volume)
RxCUI 582808, 1048144
UNII 31PZ2VAU81
Application # M022
SPL Set ID 086a0b82-e947-41c9-89e7-ba06483960c9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-01
Route ORAL
Dosage form LIQUID
Substance CARBAMIDE PEROXIDE
GPI-14 88100030002010
GPI class Gly-Oxide
GCN Seq No 009813
GCN 29891
HICL code 004272
Ingredient (HICL) Carbamide Peroxide
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8D
Therapeutic class — specific (HIC3) Oxidizing Agents
AHFS code 52:04.24.00
AHFS class Astringents (52:04)
FDB label name GLY-OXIDE 10% CLEANSER
FDB brand name Gly-Oxide
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 63029-500-01 — 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 → 63029-0500-01. 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.

🏭 Manufacturer & labeler

LabelerMedtech Products Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code63029
First marketedJun 2012
Product typeHuman Otc Drug
Portfolio57 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

Label name GLY-OXIDE 10% CLEANSER Ingredient Carbamide Peroxide
🧪 What is this product?

Gly-Oxide is an over-the-counter oral liquid containing carbamide peroxide, an antimicrobial agent that breaks down into hydrogen peroxide and urea when in contact with oral tissues. This type of product is commonly used to help remove debris, reduce bacteria, and promote cleansing in the mouth and throat. Carbamide peroxide in oral rinses is typically used as an aid for minor mouth irritations and to support oral hygiene routines.

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.

🧪 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • 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.

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

The official label also statescitric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, 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 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 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: 60 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
Gly-Oxide 100 mg/mLthis 63029-0500-01 Medtech 1 bottle — — 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

🏛️
2012
On the market since
Jun 2012
📍
2026
Currently FDA-listed
14 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 Gly-Oxide (this brand).

Top reported reactions

Diarrhoea14
Chronic Kidney Disease9
Fatigue9
Pneumonia9
Pyrexia8
Abdominal Pain7
Acute Kidney Injury7

Reporter sex

0 reports

Serious outcomes

Hospitalization78
Death24
Disabling8
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 0
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
63029-0500-01 You're viewing this 1 BOTTLE in 1 CARTON (63029-500-01) / 15 mL in 1 BOTTLE 2012-06-01 Active
63029-0500-02 1 BOTTLE in 1 CARTON (63029-500-02) / 60 mL in 1 BOTTLE 2012-06-01 Active

Pack size FAQ

What quantity is in NDC 63029-0500-01?
NDC 63029-0500-01 is listed by the FDA — 1 bottle in 1 carton / 15 ml in 1 bottle.
What NDC number is used to bill for this package of Gly-Oxide Carbamide Peroxide 100 mg/mL Liquid?
Bill NDC 63029-0500-01 — the 11-digit billing format is 63029050001. 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 63029-500-01, 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: 63029-0500-01, written without dashes as 63029050001. 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 63029-0500-01, the first segment (63029) is the labeler code FDA assigned to Medtech Products Inc.; the middle segment (0500) 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 Medtech Products 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 1 bottle (63029-0500-02). 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?
Medtech 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.

📄 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
🎯 Indications and Usage 45 words ▾

Uses temporary use in cleansing: canker sores minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

⏱️ Dosage and Administration 114 words ▾

Directions replace tip on bottle when not in use Adults and children 2 years and older: use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor For direct application do not dilute apply several drops directly from the bottle onto affected area spit out after 2 to 3 minutes As a mouthwash (oral rinse) place 10 to 20 drops onto tongue mix with saliva swish around in the mouth over the affected area for at least 1 minute and spit out Children under 12 years : should be supervised in the use of this product Children under 2 years : consult a dentist or doctor

⚠️ Warnings 84 words ▾

Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor. When using this product do not swallow avoid contact with eyes Stop use and ask a doctor if: swelling, rash or fever develops irritation, pain, or redness persists or worsens sore mouth symptoms do not improve in 7 days Keep out of the reach of children. If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 12 words ▾

Active ingredient Carbamide peroxide 10% non USP* *pH differs from USP specifications

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water

🎯 Purpose 7 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 ↗
← 63029-0325-01 · Medtech 63029-0501-01 · Medtech →
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.