NeilMed Clear Canal Earwax Removal kit Carbamide peroxide 65 mg/mL Solution/ Drops
by NEILMED PHARMACEUTICALS INC · 1 BOTTLE, DROPPER in 1 KIT (13709-314-01) / 15 mL in 1 BOTTLE, DROPPER
NDC 13709-0314-01
🏷️ FDA NDC (as labeled)
13709-314-01
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 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)
13709-314-01
Product NDC
13709-314
11-digit billing NDC
13709031401
RxCUI
702050
UNII
31PZ2VAU81
UPC
0705928602755
Application #
M014
SPL Set ID
d330552d-07b6-f01e-e053-2a95a90a7ca5
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-12-25
Route
AURICULAR (OTIC)
Dosage form
SOLUTION/ DROPS
Substance
CARBAMIDE PEROXIDE
GCN Seq No
083944
GCN
53018
HICL code
039487
Ingredient (HICL)
Carbamide Peroxide/Nacl/Nahco3
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q8
Therapeutic class — intermediate (HIC2)
Otic Preparations
HIC3 code
Q8R
Therapeutic class — specific (HIC3)
Ear Preparations,Ear Wax Removers
AHFS code
52:04.24.00
AHFS class
Astringents (52:04)
FDB label name
CLEARCANAL EAR WAX COMPLETE
FDB brand name
Clearcanal
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 13709-314-01 — 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 → 13709-0314-01. 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
LabelerNEILMED PHARMACEUTICALS INC
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code13709
First marketedDec 2021
Product typeHuman Otc Drug
Portfolio13 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 CLEARCANAL EAR WAX COMPLETE Ingredient Carbamide Peroxide/Nacl/Nahco3
🧪 What is this product?
NeilMed Clear Canal Earwax Removal kit is an over-the-counter ear drop solution containing carbamide peroxide. This product is applied directly into the ear canal and is typically used to soften and help remove excess earwax buildup. Carbamide peroxide functions as a cerumenolytic agent, meaning it breaks down earwax through gentle chemical action, making it easier to flush out during the removal process included with the kit.
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 Carbamide peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 5UTX5635HP
Oxyquinoline is a synthetic organic compound used in some medications as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in liquid formulations.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesGlycerin, Oxyquinoline USP Grade Water, USP Sodium Chloride (9mg/ml), USP Sodium Bicarbonate (0.4mg to 1.0mg/ml) to neutralize pH. Benzalkonium Chloride is added as a preservative
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/mLthis 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/mL 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
🏛️
2021
On the market since
Dec 2021
📍
2026
Currently FDA-listed
5 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 NeilMed Clear Canal Earwax Removal kit (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 62%
Female · 38%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 13709-0314-01 You're viewing this | 1 BOTTLE, DROPPER in 1 KIT (13709-314-01) / 15 mL in 1 BOTTLE, DROPPER | 2021-12-25 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Kit / multi-component package
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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 13709-314-01, 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: 13709-0314-01, written without dashes as 13709031401. 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 13709-0314-01, the first segment (13709) is the labeler code FDA assigned to NEILMED PHARMACEUTICALS INC; the middle segment (0314) 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 NEILMED PHARMACEUTICALS INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NEILMED 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 ▾
Uses For occasional use as an aid to soften, loosen, and remove excessive earwax.
Directions FOR USE IN THE EAR ONLY Adults and children over 12 years of age: Tilt head sideways Place 10 drops into each ear Tip of the applicator should not enter ear canal Keep drops in the ears for ten minutes by keeping your head tilted or using earplugs Rinse ears after treatment by gently flusing each ear with NeilMed®ClearCanal® spray or bulb syringe Use up to twice per week, or as recommended by your physician.
⏱️ Dosage and Administration ▾
Directions: This product is intended for use on adults and children over 12 years of age. Consult your physician for use on children under 12. Tilt head sideways and place 10 drops of ClearCanal Carbamide peroxide into each ear canal by squeezing the plastic dropper bottle provided with this system.
The tip of bottle should not enter ear canal. Keep drops in ear for 10 minutes by head tilted or placing enclosed ear plugs in ears. It is normal to feel warmth in ear due to carbamide peroxide.
Remove ear plugs. Attach the special drainage collection cup to the canister to avoid the rinse solution dripping out of your ear. Flush ears with the NeilMed ClearCanal specially designed actuator nozzle for 10 seconds or as desired to achieve adequate flushing.
Gently tilt head side to side to drain out residual liquid and dry ears with a clean dry towel wrapped on a finger.
⚠️ Warnings ▾
! Warnings Avoid using the product and ask a doctor before use if you have : Ear pain, drainage or discharge Impacted earwax Ear infection, irritation or rash in the ear. Meniere's Syndrome, dizziness, or vertigo An injury or perforation (hole) of the eardrum Tubes in the ears Has recent ear/mastoid surgery Had an allergic reaction to carbamide peroxide or other ingredients in this product in the past.
Heart disease, high blood pressure, thyroid disease or diabetes To prevent contamination, do not share this product with others.
📦 Storage and Handling ▾
Other Information: Store product in the outer carton, and do not discard carton or enclosed printed materials. Product will foam on contact with earwax due to release of oxygen; there may be an associated crackling sound. Keep cap on bottle when not in use.
Contents in canister are under pressure; do not puncture or incinerate Recommended storage conditions: Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be exposed to temperatures ranging from 41ºF to 131ºF (5ºC to 55ºC) during transportation. Store out of sunlight, away from heat sources and avoid freezing
🧪 Active Ingredient ▾
Drug Facts Active Ingredients Carbamide Peroxide 6.5%
🧪 Inactive Ingredients ▾
Inactive Ingredients Glycerin, Oxyquinoline
Ingredients for ClearCanal® Saline Spray : USP Grade Water, USP Sodium Chloride (9mg/ml), USP Sodium Bicarbonate (0.4mg to 1.0mg/ml) to neutralize pH. Benzalkonium Chloride is added as a preservative
🎯 Purpose ▾
Purpose Earwax Softener
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.