![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 — NDC 54973-3172-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b18453e-e338-4b8e-9856-85aca8c46ee1&name=Screenshot_EARDA.jpg)
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 Hyland's Inc. · 1 BOTTLE, DROPPER in 1 CARTON (54973-3172-1) / 10 mL in 1 BOTTLE, DROPPER
NDC 54973-3172-01
🏷️ FDA NDC (as labeled)
54973-3172-1
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 →
🆔 Identity & classification
FDA NDC (as labeled)
54973-3172-1
Product NDC
54973-3172
11-digit billing NDC
54973317201
NCPDP billing unit
ML — per mL (volume)
UNII
6GZW20TIOI, H0G9379FGK, FGL3685T2X, C88X29Y479, 4M1169RWJD, 70FD1KFU70
UPC
0354973751620
SPL Set ID
9b18453e-e338-4b8e-9856-85aca8c46ee1
Established class (EPC)
Blood Coagulation Factor; Cations
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
2004-06-17
Route
AURICULAR (OTIC)
Dosage form
LIQUID
Substance
BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PATENS WHOLE; SULFUR
GPI-14
99870010002030
GPI class
Earache Drops
Why two NDCs?
The FDA registers this code as 54973-3172-1 — 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 → 54973-3172-01. 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.
🏭 Manufacturer & labeler
LabelerHyland's Inc.
Labeler code54973
First marketedJun 2004
Product typeHuman Otc Drug
Portfolio69 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?
This is an unapproved homeopathic liquid product applied into the ear. It contains six ingredients, including belladonna leaf, chamomile, and sulfur, that are used in homeopathic practice. Homeopathic products are marketed based on traditional use rather than FDA evaluation for effectiveness. The specific claims or intended uses for this formulation follow homeopathic principles and have not been established through standard medical testing.
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.
💬 Questions about belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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]/mLthis 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]/mL 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
🏛️
2004
On the market since
Jun 2004
📍
2026
Currently FDA-listed
22 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 EARACHE DROPS (this brand).
Top reported reactions
Reporter sex
Female · 100%
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54973-3172-01 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (54973-3172-1) / 10 mL in 1 BOTTLE, DROPPER | 2004-06-17 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
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 | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 54973-3172-1, 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: 54973-3172-01, written without dashes as 54973317201. 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 54973-3172-01, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (3172) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Hyland's Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hyland's 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.
📄 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 ▾
Uses Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ■ ear pain or itching ■ irritability ■ minor fever
⏱️ Dosage and Administration ▾
Directions Adults and children ages 2 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.
⚠️ Warnings ▾
Warnings Keep away from eyes. Do not use you have ear tubes, damaged ear drums or after ear surgery. Stop use and ask a doctor if: ■ symptoms persist for more than 48 hours or worsen. ■ any discharge from ear is present. ■ symptoms are accompanied by a fever. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children
🧪 Active Ingredient ▾
Active ingredients Purpose Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) minor fever Calcarea Carbonica 30C HPUS throbbing ear pain Chamomilla 30C HPUS occasional 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 ▾
Inactive ingredients Citric Acid, Glycerine, Purified Water, Sodium Benzoate.
🎯 Purpose ▾
Purpose Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever
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 ↗
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.