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EarBalance Ear Pain Drops Lidocaine Hydrochloride Otic Solution 40 mg/mL Solution/ Drops, 14 mL — NDC 87541-0644-68 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EarBalance Ear Pain Drops Lidocaine Hydrochloride Otic Solution 40 mg/mL Solution/ Drops, 14 mL — NDC 87541-644-68 (Billing 87541-0644-68)

by Marie's Original Formulas LLC · 14 mL in 1 BOTTLE, PLASTIC

This is a package of 14 mL of EarBalance Ear Pain Drops Lidocaine Hydrochloride Otic Solution 40 mg/mL Solution/ Drops from Marie's Original Formulas LLC, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 87541-0644-68
🏷️ FDA NDC (as labeled) 87541-644-68 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 87541-644-68 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87541 labeler · 644 product · 68 package
Package marketed since
Jun 15, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8754164468 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87541-644-68
Product NDC 87541-644
11-digit billing NDC 87541064468
UNII 98PI200987
Application # M014
SPL Set ID 54dc3642-0b7a-07d8-e063-6294a90ad556
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-15
Route AURICULAR (OTIC)
Dosage form SOLUTION/ DROPS
Substance LIDOCAINE
Why two NDCs? The FDA registers this code as 87541-644-68 — 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 → 87541-0644-68. 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

📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →

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
87541-0644-68 You're viewing this Main listing 14 mL in 1 BOTTLE, PLASTIC 2026-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
EarBalance Ear Pain Drops 40 mg/mL 87541-0498-25 Marie's 14 ml — — FDA listed —
EarBalance Ear Pain Drops 40 mg/mLthis 87541-0644-68 Marie's 14 ml — — FDA listed —
EarBalance Ear Pain Drops 40 mg/mL 87541-0896-34 Marie's 14 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 0UE22Q87VC
    Apple cider vinegar is a sour liquid made from fermented apples. It's used in medicines as a flavoring agent and to help adjust the acidity level of the product.
  • UNII QI7G114Y98
    Echinacea purpurea is a dried plant extract from the purple coneflower. It's included in some formulations as a botanical ingredient to support the product's intended benefits, though it serves no structural role like binding or coating.
  • UNII R763EBH88T
    A natural plant extract from goldenseal root used as a preservative and antimicrobial agent in some herbal formulations. It helps prevent spoilage and extends shelf life.

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

The official label also statesAlcohol, Acetum (Apple Cider Vinegar), Echinacea Purpurea Extract, Hydrastis Canadensis Root Extract

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

LabelerMarie's Original Formulas LLC
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code87541
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Marie's Original Formulas LLC labeler code 87541

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses Temporarily relieves ear discomfort and minor pain associated with swimmer's ear, ear canal irritation, and post-irritation soreness.

⏱️ Dosage and Administration 42 words ▾

Directions Ages 6-12: 3-5 drops up to 4 times daily Ages 2-5: 2-3 drops up to 3 times daily Keep head tilted 2-3 minutes Do not use longer than 4 days unless directed by a doctor Under 2 years: ask a doctor

⚠️ Warnings 8 words ▾

Warnings For use in the ear canal only.

📦 Storage and Handling 23 words ▾

Other Information Store at 20° to 25°C (68° to 77°F) Protect from light Keep tightly closed Do not use if seal is broken

🧪 Active Ingredient 6 words ▾

Active Ingredient Lidocaine HCl 4% Back

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Alcohol, Acetum (Apple Cider Vinegar), Echinacea Purpurea Extract, Hydrastis Canadensis Root Extract

🎯 Purpose 3 words ▾

Purpose Local anesthetic

📄 Do Not Use 26 words ▾

Do not use if your child has a damaged eardrum if your child has ear tubes if allergic to lidocaine or any ingredient in this product

📄 Ask a Doctor Before Use If 23 words ▾

Ask a doctor before use if ear drainage, bleeding, fever, hearing loss, dizziness, ringing in the ears, or severe ear pain is present

📄 When Using This Product 15 words ▾

When using this product avoid contact with eyes do not swallow temporary numbness may occur

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if symptoms worsen or last longer than 48 hours rash or irritation develops

📄 Keep Out of Reach of Children 15 words ▾

Keep out of reach of children If swallowed, contact a Poison Control Center right away.

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-888-48-MARIE

📄 Package Label / Principal Display Panel 36 words ▾

Principal Display Panel EarBalance by Marie Originals Ear Pain Drops Kids Ear Pain Relief With 4% Lidocaine HCl + Botanical Extracts Fast-Acting Relief pH-Balanced Ingredients Gentle for Kids' Ears Net 0.5 fl oz (14 mL) Front

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 Marie's Original Formulas LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Marie's Original Formulas LLC 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.
← 87541-0632-72 · Marie's 87541-0737-65 · Marie's →
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.