Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
DEBROX Carbamide Peroxide 65 mg/mL Liquid — NDC 50090-4201-0 (Billing 50090-4201-00)
by A-S Medication Solutions · 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
This is a package of DEBROX Carbamide Peroxide 65 mg/mL Liquid from A-S Medication Solutions, marketed since Aug 2012 and currently FDA-listed. It is this product's only package size.
NDC 50090-4201-00
🏷️ FDA NDC (as labeled)
50090-4201-0
billing pads the package segment with a zero
🗂️ 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 →
⚠️
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
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
50090-4201-0
Product NDC
50090-4201
11-digit billing NDC
50090420100
NCPDP billing unit
ML — per mL (volume)
UNII
31PZ2VAU81
Application #
M014
SPL Set ID
8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2012-08-01
Route
AURICULAR (OTIC)
Dosage form
LIQUID
Substance
CARBAMIDE PEROXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
008120
GCN
34401
HICL code
004272
Ingredient (HICL)
Carbamide Peroxide
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
DEBROX 6.5% EAR DROPS
FDB brand name
Debrox
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 008120
- GCN: 34401
- HICL (First Databank): 004272
- AHFS class code: 52:04.24.00
- RxCUI (RxNorm): 702050
Why two NDCs?
The FDA registers this code as 50090-4201-0 — a 5-4-1 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 package segment → 50090-4201-00. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name DEBROX 6.5% EAR DROPS Ingredient Carbamide Peroxide
🧪 What is this product?
Debrox is an over-the-counter liquid earwax removal product applied directly into the ear canal. It contains carbamide peroxide, which works by breaking down and loosening hardened earwax through a gentle foaming action. This product is part of the OTC monograph category for cerumenolytic agents and is typically used to soften and help remove excess earwax buildup that may cause hearing difficulty or ear discomfort.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Carbamide Peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50090-4201-00 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER | 2019-03-19 | — | Active |
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 | — | Discontinued | — |
| 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/mLthis 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2012
On the market since
Aug 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.
- FDA Orange Book · refreshed Sep 3, 2026
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 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.
-
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.
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerA-S Medication Solutions
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code50090
First marketedAug 2012
Product typeHuman Otc Drug
Portfolio2,811 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📦 How Supplied / Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Ask a Doctor Before Use If
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For occasional use as an aid to soften, loosen, and remove excessive earwax
⏱️ Dosage and Administration ▾
Directions FOR USE IN THE EAR ONLY adults and children over 12 years of age: tilt head sideways place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in ear • use twice daily for up to four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe children under 12 years: consult a doctor
⚠️ Warnings ▾
Warnings Ask a doctor before use if you have ear drainage or discharge • ear pain irritation or rash in the ear • dizziness an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than four days excessive earwax remains after use of this product
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Product: 50090-4201 NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON
🧪 Active Ingredient ▾
Active ingredient Carbamide peroxide 6.5% non USP
🧪 Inactive Ingredients ▾
Inactive Ingredients citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water
🎯 Purpose ▾
Purpose Earwax removal aid
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have ear drainage or discharge • ear pain irritation or rash in the ear • dizziness an injury or perforation (hole) of the eardrum • recently had ear surgery
📄 When Using This Product ▾
When using this product avoid contact with the eyes
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if you need to use for more than four days excessive earwax remains after use of this product
📄 Keep Out of Reach of Children ▾
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
📄 Other Information ▾
Other information do not store above 25C (77F) store bottle in the outer carton, in an upright position product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound. keep tip on bottle when not in use
📄 Questions or Comments ▾
Questions? 1-866-255-5202 Debrox.com
📄 Package Label / Principal Display Panel ▾
Carbamide Peroxide Label Image
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 ↗
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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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.
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.