Home › NDC Lookup › Ingredients › Chamomile, Mercurius Solubilis, Sulfur › 68016-0377-00
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Premier Value Ear Relief Ear Drops CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR 10 [hp_X]/mL; 15 [hp_X]/mL; 12 [hp_X]/mL Solution/ Drops — NDC 68016-377-00 (Billing 68016-0377-00)

by Chain Drug Consortium, LLC · 1 BOTTLE in 1 BOX / 12 mL in 1 BOTTLE

This is a package of Premier Value Ear Relief Ear Drops CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR 10 [hp_X]/mL; 15 [hp_X]/mL; 12 [hp_X]/mL Solution/ Drops from Chain Drug Consortium, LLC, no longer marketed (first marketed Oct 2005), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 68016-0377-00
🏷️ FDA NDC (as labeled) 68016-377-00 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 68016-377-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68016 labeler · 377 product · 00 package
Package marketed since
Oct 1, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0840986019616
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jan 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-377-00
Product NDC 68016-377
11-digit billing NDC 68016037700
NCPDP billing unit ML — per mL (volume)
UNII FGL3685T2X, 324Y4038G2, 70FD1KFU70
UPC 0840986019616
SPL Set ID b0db3da2-c180-4ff5-a8ee-4ec220798f64
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jan 2025)
Marketing start 2005-10-01
Route AURICULAR (OTIC)
Dosage form SOLUTION/ DROPS
Substance CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR
Why two NDCs? The FDA registers this code as 68016-377-00 — 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 → 68016-0377-00. 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 ear drop solution marketed for use in the ear canal. It contains chamomile, mercurius solubilis, and sulfur as active ingredients, which in homeopathic practice are traditionally selected for ear-related concerns. Homeopathic products are marketed based on homeopathic tradition rather than clinical evidence, and the FDA does not evaluate them for safety or effectiveness. This product is unapproved by the FDA.

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
68016-0377-00 You're viewing this Main listing 1 BOTTLE in 1 BOX / 12 mL in 1 BOTTLE 2005-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Premier Value Ear Relief Ear Drops 10 [hp_X]/mL; 15 [hp_X]/mL; 12 [hp_X]/mLthis 68016-0377-00 Chain 1 bottle — — FDA listed —
Equaline Ear Relief Ear Drops 10 [hp_X]/mL; 15 [hp_X]/mL; 12 [hp_X]/mL 41163-0846-07 United 1 bottle — — FDA listed —
Top Care Ear Relief Ear Drops 10 [hp_X]/mL; 15 [hp_X]/mL; 12 [hp_X]/mL 36800-0846-07 Topco 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

🏛️
2005
On the market since
Oct 2005
📍
2026
Currently FDA-listed
21 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 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 statesVegetable glycerin

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

LabelerChain Drug Consortium, LLC
Labeler code68016
First marketedOct 2005
Product typeHuman Otc Drug
Portfolio49 products on file

More NDCs from Chain Drug Consortium, LLC labeler code 68016

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

⏱️ Dosage and Administration 76 words ▾

Directions FOR USE IN THE EAR ONLY. Remove tamper-evident seal from neck of bottle. Twist cap off bottle. Tilt head sideways. Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal). Keep drops in ear by keeping head tilted or placing cotton in ear. Use up to 4 times daily for no more than 48 hours, or as direted by a doctor. Children under 12 years of age consult a doctor.

⚠️ Warnings 85 words ▾

Warnings Do not use in the eyes. Initial exacerbation may occur. Ask a doctor before use if you have: ear drainage or discharge pain, irritation, or rash in the ear had ear surgery dizziness Stop use and ask a doctor if: irritation (too much burning) or pain occurs symptoms persist for more than 48 hours If pregnant or breast feeding, ask a health professional before use.

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

🧪 Active Ingredient 22 words ▾

Active ingredients Chamomilla 10X Mercurius solubilis 15X Sulphur 12X Purpose sensitivity to dreafts, soothing fullness, sensitivity to cold itchiness, sensitivity to water

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient Vegetable glycerin

🎯 Purpose 13 words ▾

Purpose sensitivity to dreafts, soothing fullness, sensitivity to cold itchiness, sensitivity to water

📄 Do Not Use 10 words ▾

Do not use in the eyes. Initial exacerbation may occur.

📄 Ask a Doctor Before Use If 23 words ▾

Ask a doctor before use if you have: ear drainage or discharge pain, irritation, or rash in the ear had ear surgery dizziness

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if: irritation (too much burning) or pain occurs symptoms persist for more than 48 hours

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 2 words ▾

Questions? 1-800-328-5890

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Bottle3

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 No longer marketed (per FDA listing data)

About homeopathic listings

Premier Value Ear Relief Ear Drops CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR 10 [hp_X]/mL; 15 [hp_X]/mL; 12 [hp_X]/mL SOLUTION/ DROPS 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Chain Drug Consortium, 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.
← 68016-0344-07 · Chain 68016-0400-96 · Chain →
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.