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WALGREENS EARACHE DROPS belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL Liquid

by Walgreen Company · 1 BOTTLE, DROPPER in 1 CARTON (0363-3233-15) / 10 mL in 1 BOTTLE, DROPPER
NDC 00363-3233-15
🏷️ FDA NDC (as labeled) 0363-3233-15 billing pads the labeler 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

Past resolved recalls for this product (1)
Class II · May 24, 2022 · Terminated — Microbial contamination of non-sterile product. (Grato Holdings, Inc.) · FDA recall D-0991-2022

🆔 Identity & classification

FDA NDC (as labeled) 0363-3233-15
Product NDC 0363-3233
11-digit billing NDC 00363323315
UNII 6GZW20TIOI, H0G9379FGK, FGL3685T2X, C88X29Y479, 4M1169RWJD, 70FD1KFU70
UPC 0311917217123
SPL Set ID c573dc3c-992e-604d-e053-2995a90a0ff4
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-22
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PATENS WHOLE; SULFUR
Why two NDCs? The FDA registers this code as 0363-3233-15 — 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 → 00363-3233-15. 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

LabelerWalgreen Company
Labeler code00363
First marketedJun 2021
Product typeHuman Otc Drug
Portfolio468 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

🧪 What is this product?

Walgreens Earache Drops is a homeopathic liquid product applied in the ear. It contains six homeopathic ingredients (belladonna leaf, chamomile, lycopodium clavatum spore, anemone patens, calcium carbonate, and sulfur) that are traditionally used in homeopathic practice for ear-related complaints. Homeopathic products are marketed based on homeopathic tradition and have not been evaluated by the FDA for safety or effectiveness. This product is sold as an over-the-counter homeopathic drug.

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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • 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 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.

4 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesBenzalkonium chloride, Citric acid, Glycerin, 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Earache Drops 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL 54973-3172-01 Hyland's 1 bottle — — FDA listed —
Walgreens Earache Drops 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mLthis 00363-3233-15 Walgreen 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

🏛️
2021
On the market since
Jun 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 Belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur — the ingredient across all brands.

Top reported reactions

Ear Discomfort1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00363-3233-15 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (0363-3233-15) / 10 mL in 1 BOTTLE, DROPPER 2021-06-22 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

WALGREENS EARACHE DROPS belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL; 30 [hp_C]/mL LIQUID is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 — Not published for this NDC No photo available yet for this listing.
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 "Unapproved Homeopathic". 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 0363-3233-15, 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: 00363-3233-15, written without dashes as 00363323315. 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 00363-3233-15, the first segment (00363) is the labeler code FDA assigned to Walgreen Company; the middle segment (3233) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 Walgreen Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreen Company 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 59 words ▾

Uses Uses* • For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmer’s ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

⏱️ Dosage and Administration 93 words ▾

Directions Directions Suitable for adults and children overtheageof2.•Forusein the ears only. • Remove any hearing aids before using this product. • Use 3 to 5 drops four times per day or as needed. • Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 1 – 2 minutes or gently place cotton in the ear to keep drops in.

⚠️ Warnings 138 words ▾

Warnings USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. • Keep away from eyes. • Do not take by mouth. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur. • A Physician should always be consulted to rule out serious causes. • If accidental contact with eyes occurs, flush eyes with water and consult a doctor. • If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Do not use: • If you have ear drainage, irritation, discharge or rash in the ear, consult a physician • With ear tubes, damaged ear drums or after surgery. • If drops become cloudy.

🧪 Active Ingredient 57 words ▾

Active ingredients Purpose Belladonna 30C HPUS Fever Calcarea Carbonica 30C HPUS Throbbing ear pain Chamomilla 30C HPUS Sleeplessness and irritability Lycopodium 30C HPUS Ear pain Pulsatilla 30C HPUS Ear itching, pain worse at night Sulphur 30C HPUS Ear pain with burning "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients Benzalkonium chloride, Citric acid, Glycerin, Purified water.

🎯 Purpose 33 words ▾

Purpose Belladonna - Fever Calcarea carbonica - Throbbing ear pain Chamomilla - Sleeplessness and irritability Lycopodium - Ear pain Pulsatilla - Ear itching, pain worse at night Sulphur - Ear pain with burning

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00363-3219-01 · Walgreen 00363-3255-01 · Walgreens →
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.