Home › NDC Lookup › Ingredients › Atropa Belladonna, Anemone Pulsatilla, L... › 11822-3644-03
EAR CARE EARACHE DROPS ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, 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 11822-3644-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EAR CARE EARACHE DROPS ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, 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 11822-3644-3 (Billing 11822-3644-03)

by Rite Aid Corporation · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of EAR CARE EARACHE DROPS ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, 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 from Rite Aid Corporation, marketed since Aug 2017 and currently FDA-listed. It is this product's only package size.

NDC 11822-3644-03
🏷️ FDA NDC (as labeled) 11822-3644-3 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

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 11822-3644-3 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11822 labeler · 3644 product · 3 package
Package marketed since
Aug 3, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0011822364430
FDA record last changed
Jul 24, 2026
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-0989-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11822-3644-3
Product NDC 11822-3644
11-digit billing NDC 11822364403
UNII WQZ3G9PF0H, 2E32821G6I, G0R4UBI2ZZ, C88X29Y479, I76KB35JEV, 70FD1KFU70
UPC 0011822364430
SPL Set ID 58f1f79f-f1dd-3094-e053-2991aa0ac591
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-03
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SULFUR

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99870010002030
GPI class RA Earache Drops
Quick answers
  • GPI-14 (Medi-Span): 99870010002030
Why two NDCs? The FDA registers this code as 11822-3644-3 — 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 → 11822-3644-03. 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.

Clinical

🧪 What is this product?

This is a homeopathic liquid ear drops product intended for auricular (ear) use. It contains six ingredients, each prepared according to homeopathic methods: atropa belladonna and anemone pulsatilla are plants traditionally used in homeopathic practice for ear-related complaints; lycopodium clavatum spore, matricaria chamomilla (chamomile), and sulfur are also common homeopathic ingredients associated with various conditions; and oyster shell calcium carbonate is included as well. Homeopathic products are marketed based on traditional homeopathic theory and are not evaluated by the FDA for safety or effectiveness.

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
11822-3644-03 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 2017-08-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ear Care 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 11822-3644-03 Rite 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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.

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, Glycerine, 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.

Manufacturer & labeler

LabelerRite Aid Corporation
Labeler code11822
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio326 products on file

More NDCs from Rite Aid Corporation labeler code 11822

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

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 “swimmers ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

⏱️ Dosage and Administration 108 words ▾

Directions Suitable for adults and children over the age of 2. • For use in the ears only • Remove any hearing aids • Use 3-5 drops twice per day or as needed. Warm contents to body temperature by holding bottle in your hands. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in.

Tilt your head to the side and let solution drip into the ear. Never put the tip in 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 139 words ▾

Warnings USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. Keep away from eyes. 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 pregnant or breast feeding, ask a health professional before use.

Stop and ask a doctor it: Symptoms worsen or continue for more than 48 hours There is discharge from the ear. A fever of greater than 102° is present 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, with damaged ear drums or after surgery. if drops become cloudy.

📦 Storage and Handling 12 words ▾

• Store at 15°C-30°C (59°F-86°F) • Protect from light and excessive moisture

🧪 Active Ingredient 59 words ▾

Active ingredients Purpose "HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States. 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

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

🎯 Purpose 59 words ▾

Active ingredients Purpose "HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States. 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

📄 Do Not Use 32 words ▾

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

📄 Ask a Doctor Before Use If 29 words ▾

Stop and ask a doctor it: Symptoms worsen or continue for more than 48 hours There is discharge from the ear. A fever of greater than 102° is present

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 6 words ▾

Questions or comments? (800) RITE-AID (800-748-3243)

📄 Package Label / Principal Display Panel 38 words ▾

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton NDC 11822-3644-3 ear care earache drops homeopathic eases pain calms and soothes relieves itching due to cold & flu, swimmers ear & allergy

0.33FL. OZ. (10 mL) External box

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 Homeopathic listing

About homeopathic listings

EAR CARE EARACHE DROPS ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, 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) ✓ 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 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 Rite Aid Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rite Aid Corporation 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.
← 11822-3627-03 · Rite 11822-3670-02 · Rite →
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.