Home › NDC Lookup › Ingredients › Leader Ear Drops For Swimmers › 70000-0478-01
LEADER Ear Drops for Swimmers 950 mg/mL Liquid, 30 mL — NDC 70000-0478-01 package photo

LEADER Ear Drops for Swimmers 950 mg/mL Liquid, 30 mL

by Cardinal Health, 110 dba Leader · 30 mL in 1 CONTAINER (70000-0478-1)
NDC 70000-0478-01
🏷️ FDA NDC (as labeled) 70000-0478-1 billing pads the package 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70000-0478-1
Product NDC 70000-0478
11-digit billing NDC 70000047801
NCPDP billing unit ML — per mL (volume)
RxCUI 631799
UNII ND2M416302
Application # M014
SPL Set ID 874857eb-2a9d-6ef7-e053-2995a90af156
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-24
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance ISOPROPYL ALCOHOL
GPI-14 87400046000960
GCN Seq No 014183
GCN 88490
HICL code 005165
Ingredient (HICL) Isopropyl Alcohol In Glycerin
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 Q8Y
Therapeutic class — specific (HIC3) Ear Preparations, Miscellaneous (Otc)
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name EAR DROPS FOR SWIMMERS
FDB brand name Ear Drops For Swimmers
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0478-1 — 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 → 70000-0478-01. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health, 110 dba Leader
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio34 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 EAR DROPS FOR SWIMMERS Ingredient Isopropyl Alcohol In Glycerin
🧪 What is this product?

Leader Ear Drops for Swimmers is a liquid product applied directly into the ear canal. It contains isopropyl alcohol, which functions as a drying agent and is typically used to help remove water from the ear and reduce moisture that can promote bacterial or fungal growth. This is an over-the-counter monograph drug, meaning it is marketed under established FDA guidelines for its product category rather than through individual drug approval.

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.

🧪 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.

💲 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 $0.084 $2.51 / 30 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.084 $0.065
▲ Up 28% over the last 10 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LEADER Ear Drops for Swimmers 950 mg/mLthis 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 +9%
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/100mL 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

🏛️
2019
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0478-01 You're viewing this 30 mL in 1 CONTAINER (70000-0478-1) 2019-04-24 Active

📄 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 5 words ▾

Dries water in the ears

⏱️ Dosage and Administration 9 words ▾

Apply 4 to 5 drops in each affected ear

⚠️ Warnings 13 words ▾

Flammable: Keep away from fire or flame Do not use in the eyes

🧪 Active Ingredient 7 words ▾

Isopropyl Alcohol 95% in 5% Anhydrous Glycerin

🧪 Inactive Ingredients 1 words ▾

Glycerin

🎯 Purpose 3 words ▾

Ear Drying Aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0477-01 · CARDINAL 70000-0479-01 · CARDINAL →
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.