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Debrox Kids isopropyl alcohol 95 mL/100mL Liquid — NDC 63029-0325-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Debrox Kids isopropyl alcohol 95 mL/100mL Liquid — NDC 63029-325-01 (Billing 63029-0325-01)

by Medtech Products Inc. · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Debrox Kids isopropyl alcohol 95 mL/100mL Liquid from Medtech Products Inc., marketed since Jun 2024 and currently FDA-listed. It is this product's only package size.

NDC 63029-0325-01
🏷️ FDA NDC (as labeled) 63029-325-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 63029-325-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63029 labeler · 325 product · 01 package
Package marketed since
Jun 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0042037001711
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Isopropyl Alcohol (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 · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0373-2026
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0604-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0601-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0602-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0600-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0605-2025
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) 63029-325-01
Product NDC 63029-325
11-digit billing NDC 63029032501
RxCUI 631799
UNII ND2M416302
UPC 0042037001711
Application # M014
SPL Set ID f42eee70-c4ee-44ad-85d5-a06d98ecb8b0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-01
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance ISOPROPYL ALCOHOL
Quick answers
  • RxCUI (RxNorm): 631799
Why two NDCs? The FDA registers this code as 63029-325-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63029-0325-01. 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.

RxNorm drug class

This medicine belongs to the Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Debrox Kids is an over-the-counter liquid solution applied into the ear canal. It contains isopropyl alcohol, which is commonly used to help dry the ear and reduce moisture after water exposure or swimming. This product is classified as an OTC monograph drug, meaning it follows established FDA guidelines for ear-drying products rather than being individually approved.

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.
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
63029-0325-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2024-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LEADER Ear Drops for Swimmers 950 mg/mL 70000-0478-01 Cardinal 30 ml $0.084 — Availability likely —
Swim-EAR 950 mg/mL 00168-0126-91 Fougera 1 bottle $0.091 — Availability likely —
Walgreens Swimmers Ear 95 g/100mL 00363-6107-01 Walgreens 1 bottle — — FDA listed —
HUMCO Ear Drops for Swimmers 950 mg/mL 00395-0098-91 Humco 1 bottle — — FDA listed —
Rite Aid Swimmers Ear Drops 95 g/100mL 11822-1076-00 Rite 1 bottle — — FDA listed —
Ear Drying Agent 94.998 g/100mL 11822-1233-01 Rite 1 bottle — — FDA listed —
Swimmers Ear 950 mg/mL 13709-0347-01 Neilmed 1 bottle — — FDA listed —
TopCare Swimmers Ear Drops 950 mg/mL 36800-0064-91 TOPCO 30 ml — — FDA listed —
HEB Water Drying Aid 950 mg/mL 37808-0098-91 H 30 ml — — FDA listed —
Equate Swimmers Instant Ear Dry 950 mg/mL 49035-0989-91 Walmart 30 ml — — FDA listed —
DDM Ear Drops for Swimmers 950 mg/mL 53943-0098-91 Discount 30 ml — — FDA listed —
Oido Sana .95 g/mL 58988-1100-01 ProMex 1 bottle — — FDA listed —
Debrox Swimmers Ear 95 mL/100mL 63029-0323-01 Medtech 30 ml — — FDA listed —
Debrox Kids 95 mL/100mLthis 63029-0325-01 Medtech 1 bottle — — FDA listed —
Auro Dri 95 mL/100mL 63736-0327-12 Insight 1 bottle — — FDA listed —
Quality Choice Instant Ear Dry 950 mg/mL 63868-0408-01 Chain 30 ml — — FDA listed —
Macks Dry n Clear 950 mg/mL 66354-0001-86 McKeon 30 ml — — FDA listed —
Premiere Value Ear Drops for Swimmers 950 mg/mL 68016-0820-91 Pharmacy 30 ml — — FDA listed —
ENT Essentials All Dry Ear Drying Drops .95 g/100g 68093-4501-01 Wisconsin 1 bottle — — FDA listed —
CVS Ear Drops for Swimmers 950 mg/mL 69842-0098-91 CVS 30 ml — — FDA listed —
Topcare Swimmers Ear Drops 95 mL/100g 76162-0107-01 Topco 1 bottle — — FDA listed —
Freskaro Ear Drops for Swimmers 50 mg/mL; 950 mg/mL 82645-0098-91 Pharma 1 bottle — — FDA listed —
Ear Drops for Swimmers 950 mg/mL 82645-0925-91 Pharma 30 ml — — 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
Jun 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.

What it looks like

Color white
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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesGlycerin

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

LabelerMedtech Products Inc.
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code63029
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio57 products on file

More NDCs from Medtech Products Inc. labeler code 63029

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 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 17 words ▾

Use dries water in the ears and relieves water-clogged ears after swimming showering bathing washing the hair

⏱️ Dosage and Administration 30 words ▾

Directions unscrew cap from bottle remove foil safety seal from bottle affix applicator cap to bottle remove red applicator cap tip apply 4 to 5 drops in each affected ear

⚠️ Warnings 78 words ▾

W arnings Flammable: Keep away from fire or flame Do not use in the eyes. Ask a doctor before use if you have • ear drainage or discharge • ear pain, irritation or rash in the ear • dizziness • recently had ear surgery Stop use and ask a doctor if irritation (too much burning) or pain occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 2 words ▾

Active ingredient

🧪 Inactive Ingredients 2 words ▾

Inactive Glycerin

🎯 Purpose 13 words ▾

Purpose Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid

📄 Do Not Use 6 words ▾

Do not use in the eyes.

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor before use if you have • ear drainage or discharge • ear pain, irritation or rash in the ear • dizziness • recently had ear surgery

📄 Stop Use and Ask a Doctor If 14 words ▾

Stop use and ask a doctor if irritation (too much burning) or pain occurs

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 20 words ▾

Other information recap bottle after each use keep away from heat or direct sunlight store at room temperature 15-25ºC (59-77ºF)

📄 Questions or Comments 3 words ▾

Questions? 1-800-344-7239 debrox.com

📄 Package Label / Principal Display Panel 34 words ▾

PRINCIPAL DISPLAY PANEL Debrox ® Kids Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL) PRINCIPAL DISPLAY PANEL Debrox ® Kids Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL)

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 Medtech Products Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medtech Products Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63029-0324-15 · Medtech 63029-0500-01 · Medtech →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.