Healthy Ears Carbide Peroxide 6.5 mg/mL Solution, 14.7 mL
by Vitamex USA, Corp · 14.7 mL in 1 BOTTLE, DROPPER (69469-650-05)
NDC 69469-0650-05
🏷️ FDA NDC (as labeled)
69469-650-05
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 →
🆔 Identity & classification
FDA NDC (as labeled)
69469-650-05
Product NDC
69469-650
11-digit billing NDC
69469065005
RxCUI
702050
UNII
31PZ2VAU81
Application #
M014
SPL Set ID
25953441-cd8e-5038-e063-6294a90ae401
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-10-28
Route
AURICULAR (OTIC)
Dosage form
SOLUTION
Substance
CARBAMIDE PEROXIDE
Why two NDCs?
The FDA registers this code as 69469-650-05 — 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 → 69469-0650-05. 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
LabelerVitamex USA, Corp
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code69469
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio6 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?
Healthy Ears Carbamide Peroxide is an over-the-counter otic solution (liquid applied in the ear) that functions as a cerumenolytic agent. Carbamide peroxide, the active ingredient, is commonly used to help soften and loosen earwax buildup in the ear canal. This product is marketed under FDA's OTC monograph rules for its category rather than as an individually approved application.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Carbide Peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
yellow
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 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 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 statesInactive ingredients: Water, Glycerin.
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 system | Per mL | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ear Drops Major 6.5 g/100mL 00904-6627-35 | Major | 1 bottle | $0.162 | — | Availability likely | — |
| Major Earwax Removal Drops Earwax Removal Aid 65 mg/mL 00904-7478-35 | Major | 1 bottle | $0.162 | — | Availability likely | — |
| Ear Wax Removal Drops 65 mg/mL 11527-0143-51 | Sheffield | 1 bottle | $0.162 | — | Availability likely | — |
| Good Neighbor Pharmacy Earwax Removal 46122-0556-05 | Amerisource | 1 kit | $0.162 | — | Availability likely | — |
| Good Neighbor Pharmacy Earwax Removal Drops 65 mg/mL 46122-0557-05 | Amerisource | 1 bottle | $0.162 | — | Availability likely | — |
| Leader Earwax Removal Drops Earwax Removal Aid 65 mg/mL 70000-0688-01 | Cardinal | 1 bottle | $0.162 | — | Availability likely | — |
| Foster and Thrive Earwax Removal Kit Ear wax drops 70677-1153-01 | Mckesson | 1 kit | $0.162 | — | Availability likely | — |
| Foster and Thrive Earwax Removal Drops 65 mg/mL 70677-1154-01 | Mckesson | 1 bottle | $0.162 | — | Availability likely | — |
| Deluxe Ear Wash system 00363-2231-10 | Walgreens | 1 kit | — | — | FDA listed | — |
| Ear Wax Removal Drops Up and Up 65 mg/mL 11673-0761-05 | Target | 1 bottle | — | — | FDA listed | — |
| Ear Wax Removal Aid Drops .065 mg/mL 11673-0793-15 | Target | 1 bottle | — | — | FDA listed | — |
| EarWax Removal Kit Rite Aid 11822-1222-07 | Rite | 1 kit | — | — | FDA listed | — |
| EAR WAX RMVL Rite Aid 6.5 g/100mL 11822-1224-01 | Rite | 15 ml | — | — | FDA listed | — |
| Rite Aid Earwax Removal Drops 6.5 g/100mL 11822-6117-00 | Rite | 1 bottle | — | — | FDA listed | — |
| ClearCanal Ear Wax Softerner Drops 65 mg/mL 13709-0230-01 | NeilMed | 1 bottle | — | — | FDA listed | — |
| SuavEar Earwax Removal Aid 65 mg/mL 13709-0312-01 | NEILMED | 1 bottle | — | — | FDA listed | — |
| Wax Out Plus 65 mg/mL 13709-0313-01 | NEILMED | 1 bottle | — | — | FDA listed | — |
| NeilMed Clear Canal Earwax Removal kit 65 mg/mL 13709-0314-01 | NEILMED | 1 bottle | — | — | FDA listed | — |
| Otix Ear wax Removal Drops 65 mg/mL 15579-0838-34 | Bell | 1 bottle | — | — | FDA listed | — |
| Otix Ear wax Removal System Ear wax and Bulb 15579-0839-33 | Bell | 1 kit | — | — | FDA listed | — |
| Ear Wax Removal Aid Drops 65 mg/mL 21130-0793-15 | BETTER | 1 bottle | — | — | FDA listed | — |
| TopCare Earwax Removal Kit 65 mg/mL 36800-0835-33 | TOPCO | 1 bottle | — | — | FDA listed | — |
| Equaline Earwax Removal Drops 65 mg/mL 41163-0835-34 | United | 1 bottle | — | — | FDA listed | — |
| Meijer Earwax Removal Drops 65 mg/mL 41250-0282-34 | Meijer | 1 bottle | — | — | FDA listed | — |
| Meijer Earwax Removal Kit 65 mg/mL 41250-0835-33 | Meijer | 1 bottle | — | — | FDA listed | — |
| Ear Wax Removal Drops Equate 65 mg/mL 49035-0862-01 | WALMART | 1 bottle | — | — | FDA listed | — |
| Debrox 65 mg/mL 50090-4201-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Ear Drops Major 6.5 g/100mL 50090-5273-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Clearcanal Ear Wax Softerner Drops 65 mg/mL 50090-7426-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Foster And Thrive Earwax Removal Drops 65 mg/mL 50090-7510-00 | A-S | 1 bottle | — | — | FDA listed | — |
| GoodSense Ear Wax Removal Kit 6.5 g/100mL 50804-0117-01 | Geiss, | 1 bottle | — | — | FDA listed | — |
| CVS Health Earwax Removal Drops Earwax Removal Aid 65 mg/mL 51316-0822-00 | CVS | 1 bottle | — | — | FDA listed | — |
| CVS Health Earwax Removal Kit 51316-0823-00 | CVS | 1 kit | — | — | FDA listed | — |
| ERO Ear Wax Removal Kit 6.5 g/100mL 52412-0175-01 | Randob | 1 bottle | — | — | FDA listed | — |
| DISCOUNT drug mart FOOD FAIR earwax removal kit 65 mg/mL 53943-0835-33 | Discount | 1 bottle | — | — | FDA listed | — |
| Discount Drug Mart Earwax Removal Drops 65 mg/mL 53943-0838-34 | Discount | 1 bottle | — | — | FDA listed | — |
| Family Wellness Earwax Removal Earwax and Bulb 55319-0835-01 | Family | 1 kit | — | — | FDA listed | — |
| DoloEar 6.5 g/100mL 55758-0506-01 | Pharmadel | 1 bottle | — | — | FDA listed | — |
| Ear Wax Removal Drops 65 mg/mL 57896-0339-05 | GeriCare | 1 bottle | — | — | FDA listed | — |
| Audiologists Choice Earwax Removal System 65 mg/mL 59256-0001-02 | Oaktree | 1 bottle | — | — | FDA listed | — |
| Audiologists Choice Earwax Removal Aid Drops 65 mg/mL 59256-0836-34 | Oaktree | 1 bottle | — | — | FDA listed | — |
| Debrox 65 mg/mL 63029-0321-01 | Medtech | 1 bottle | — | — | FDA listed | — |
| Quality Choice Earwax Removal Kit 65 mg/mL 63868-0026-15 | Chain | 1 bottle | — | — | FDA listed | — |
| Quality Choice Earwax Removal Drops 65 mg/mL 63868-0027-16 | Chain | 1 bottle | — | — | FDA listed | — |
| Best Choice Earwax Removal Kit 65 mg/mL 63941-0835-33 | Valu | 1 bottle | — | — | FDA listed | — |
| Best Choice Earwax Removal Drops 65 mg/mL 63941-0836-34 | Valu | 1 bottle | — | — | FDA listed | — |
| Family Care Earwax Removal .065 mg/mL 65923-0639-15 | United | 1 bottle | — | — | FDA listed | — |
| Wax Away Earwax Removal Aid 65 mg/mL 66354-0005-81 | McKeon | 1 bottle | — | — | FDA listed | — |
| Wax Away Earwax Removal System 65 mg/mL 66354-0006-80 | McKeon | 1 bottle | — | — | FDA listed | — |
| ProRinse Earwax Removal System 65 mg/mL 66354-0007-82 | McKeon | 1 bottle | — | — | FDA listed | — |
| Ear Wax Removal Aid Drops .065 mg/mL 68016-0793-15 | PHARMACY | 1 bottle | — | — | FDA listed | — |
| ENT Essentials Ear Wax Remvoer .065 g/g 68093-4503-01 | Wisconsin | 1 bottle | — | — | FDA listed | — |
| Clinere Ear Wax Remover .065 g/mL 68229-0102-02 | Quest | 1 bottle | — | — | FDA listed | — |
| Good Neighbor Pharmacy Earwax Removal Drops 65 mg/mL 68788-8586-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| GoodSense Ear Wax Removal Kit 6.5 g/100mL 68788-8615-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| Carbamide peroxide 6.5% 65 mg/mL 69168-0488-68 | Allegiant | 1 bottle | — | — | FDA listed | — |
| Harris Teeter Earwax Removal Drops 6.5 g/100mL 69256-0117-01 | Harris | 1 bottle | — | — | FDA listed | — |
| Tech Care Earwax Removal Drops 65 mg/mL 69428-0002-00 | Warner | 1 bottle | — | — | FDA listed | — |
| Tech Care Earwax Removal Kit 69428-0003-00 | Warner | 1 kit | — | — | FDA listed | — |
| ear drops .065 mg/mL 69452-0377-95 | Bionpharma | 2 bottles | — | — | FDA listed | — |
| Healthy Ears 6.5 mg/mLthis 69469-0650-05 | Vitamex | 14.7 ml | — | — | FDA listed | — |
| Ear Drops .065 mg/mL 69842-0097-45 | CVS | 1 bottle | — | — | FDA listed | — |
| Ear Wash Refill CVS 69842-0877-14 | CVS | 1 kit | — | — | FDA listed | — |
| Leader Earwax Removal Kit Earwax Removal Aid and Bulb 70000-0689-01 | Cardinal | 1 kit | — | — | FDA listed | — |
| Good Neighbor Pharmacy Earwax Removal Drops 65 mg/mL 71205-0260-15 | Proficient | 1 bottle | — | — | FDA listed | — |
| CareOne Earwax Removal Drops 65 mg/mL 72476-0838-34 | Retail | 1 bottle | — | — | FDA listed | — |
| WaxRx Ear Wax Removal Aid Drops 6.5 g/100mL 72724-0001-15 | DOCTOR | 15 ml | — | — | FDA listed | — |
| DG Health Earwax Removal kit 65 mg/mL 75712-0301-14 | DOLLAR | 1 bottle | — | — | FDA listed | — |
| TopCare Earwax Removal Drops 65 mg/mL 76162-0836-34 | Topco | 1 bottle | — | — | FDA listed | — |
| Ear Wash Refill Equate 79903-0403-50 | Walmart | 1 kit | — | — | FDA listed | — |
| Wax B Gone Ear Wax Removal Drops 65 mg/mL 82498-0149-15 | SIGMAR, | 1 bottle | — | — | FDA listed | — |
| Freskaro Earwax Removal Aid 6.5 g/100mL 82645-0097-45 | Pharma | 1 bottle | — | — | FDA listed | — |
| Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb 83324-0282-05 | Chain | 1 kit | — | — | FDA listed | — |
| Quality Choice Earwax Removal Drops Earwax Removal Aid 65 mg/mL 83324-0283-05 | Chain | 1 bottle | — | — | FDA listed | — |
| Lucid Hearing Earwax Removal Kit and Bulb 84320-0001-00 | Hearing | 1 kit | — | — | 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
🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69469-0650-05 You're viewing this | 14.7 mL in 1 BOTTLE, DROPPER (69469-650-05) | 2024-10-28 | 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 69469-650-05, 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: 69469-0650-05, written without dashes as 69469065005. 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 69469-0650-05, the first segment (69469) is the labeler code FDA assigned to Vitamex USA, Corp; the middle segment (0650) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Vitamex USA, Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Vitamex USA, Corp 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 ▾
Directions Directions Apply 5-10 drops in each affected ear. Supervise children in the use of this product. Do not use for more than 4 days.
Adults and children over 12 years of age: the tip of the applicator should not enter the ear canal. Keep the drops in the ear for several minutes by keeping the head tilted or placing cotton in the ear. Any wax remaining after treatment may be removed gently flushing the ear with the warm water, using soft rubber bulb ear syringe.
Children 12 years or younger, only use directed by a doctor.
⏱️ Dosage and Administration ▾
Directions Directions Apply 5-10 drops in each affected ear. Supervise children in the use of this product. Do not use for more than 4 days.
Adults and children over 12 years of age: the tip of the applicator should not enter the ear canal. Keep the drops in the ear for several minutes by keeping the head tilted or placing cotton in the ear. Any wax remaining after treatment may be removed gently flushing the ear with the warm water, using soft rubber bulb ear syringe.
Children 12 years or younger, only use directed by a doctor.
⚠️ Warnings ▾
Warnings Warnings: Do not us in the eyes. Ask a doctor before use if you have: ear drainage or discharge, pain, irritation, or rash in th ear, had ear surgery, dizziness.
🧪 Active Ingredient ▾
Active Ingredients Active Ingredients: Purpose Carbamide Peroxide 6.5% Ear wax removal aid
🧪 Inactive Ingredients ▾
Inactive Ingredients Inactive ingredients: Water, Glycerin.
🎯 Purpose ▾
Uses Uses: Ear wax removal aid and dries water in ears and relives water clogged ears.
No label section mentions that — try another word, or open the full label on DailyMed below.
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.