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Earwax Removal Drops Carbamide Peroxide 6.5% .065 mg/mL Liquid — NDC 00395-9133-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Earwax Removal Drops Carbamide Peroxide 6.5% .065 mg/mL Liquid — NDC 0395-9133-45 (Billing 00395-9133-45)

by Humco Holding Group, Inc · 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

This is a package of Earwax Removal Drops Carbamide Peroxide 6.5% .065 mg/mL Liquid from Humco Holding Group, Inc, marketed since Jun 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00395-9133-45
🏷️ FDA NDC (as labeled) 0395-9133-45 billing pads the labeler segment with a zero
This package
Contains15 mL in 1 bottle, dropper Pack sizes2 compare ↓
Main listing for product 0395-9133 · Also comes in: 15 ml 0395-9133-90
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0395-9133-45
Product NDC 0395-9133
11-digit billing NDC 00395913345
UNII 31PZ2VAU81
UPC 0096295137040
Application # M014
SPL Set ID a8c052d8-fb9c-09f2-e053-2a95a90a37af
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-04
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance CARBAMIDE PEROXIDE
Why two NDCs? The FDA registers this code as 0395-9133-45 — 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 → 00395-9133-45. 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.

Clinical

🧪 What is this product?

This is an over-the-counter liquid drop product applied into the ear canal. It contains carbamide peroxide, an ingredient that is commonly used in earwax removal products. Carbamide peroxide works by releasing oxygen when it contacts earwax, which helps soften and break up cerumen buildup in the ear. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness standards for this class of earwax removal products.

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.

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: 15 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00395-9133-45 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER 2019-06-04 — Active
00395-9133-90 0395-9133-90 1 CONTAINER in 1 CARTON / 15 mL in 1 CONTAINER 2019-06-04 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Earwax Removal Drops Carbamide Peroxide 6.5% .065 mg/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Earwax Removal Drops .065 mg/mLthis 00395-9133-45 Humco 1 bottle — — FDA listed —
Earwax Removal Drops .065 mg/mL 52412-0600-05 Randob 1 bottle — — FDA listed —
Ear Drops .065 mg/mL 69842-0097-45 CVS 1 bottle — — FDA listed —
Earwax Removal Drops .065 mg/mL 82645-0910-45 Pharma 1 bottle — — FDA listed —
ear drops .065 mg/mL 69452-0377-95 Bionpharma 2 bottles — — FDA listed —
Walgreens Ear Wax Remover .065 mg/mL 00363-2068-15 Walgreens 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

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 NJ7C1V83KG
    A tin-derived chemical compound used as a stabilizer and antioxidant in pharmaceutical formulations. It helps prevent degradation of active ingredients and maintains product stability during storage.
  • 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.

6 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 Sodium Stannate Purified 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.

Manufacturer & labeler

LabelerHumco Holding Group, Inc
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedJun 2019
Product typeHuman Otc Drug
Portfolio5 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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

For occasional use as an aid to soften, loosen and remove excessive earwax.

⏱️ Dosage and Administration 23 words ▾

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

⚠️ Warnings 37 words ▾

For External Use Only. Ask a doctor before use if you have: Ear drainage or discharge Ear pain, irritation, or rash in the ear Recently had ear surgery Dizziness An injury or perforation (hole) of the eadrum

🧪 Active Ingredient 3 words ▾

Carbamide Peroxide 6.5%

🧪 Inactive Ingredients 13 words ▾

Citric Acid Flavor Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Purified Water

🎯 Purpose 3 words ▾

Earwax removal aid.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 22 words ▾

CVS Label CVSWax.jpg carton

Leader Label Leader2022 LDREarwax45.jpg LDREwawax90.jpg

Rite Aid Label Rite Aid Earwax Kit 2022 RAEarwax45.jpg RAEarwax90.jpg

Major Label MajorEarwax90.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Carbamide Peroxide 6.5% — the ingredient across all brands.

Top reported reactions

Diarrhoea4
Eye Irritation3
Pain3
Asthenia2
Blood Glucose Increased2
Erythema2
Fatigue2

Reporter sex

0 reports

Serious outcomes

Hospitalization8
Life-threatening2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Humco Holding Group, 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 15 ml (00395-9133-90). 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?
Humco Holding Group, 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.
← 00395-9131-97 · Humco 00395-9136-23 · Humco →
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.