Home › NDC Lookup › Ingredients › Zinc Gluconate › 42961-0105-02
First Aid Direct Cold-EEZE Cold Remedy Zinc Gluconate 2 [hp_X]/1 Lozenge, 20-count — NDC 42961-0105-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

First Aid Direct Cold-EEZE Cold Remedy Zinc Gluconate 2 [hp_X]/1 Lozenge, 20-count — NDC 42961-105-02 (Billing 42961-0105-02)

by Cintas Corporation · 20 PACKET in 1 PACKAGE / 1 LOZENGE in 1 PACKET

This is a package of 20 lozenges of First Aid Direct Cold-EEZE Cold Remedy Zinc Gluconate 2 [hp_X]/1 Lozenge from Cintas Corporation, marketed since Jul 2023 and currently FDA-listed. It is this product's only package size.

NDC 42961-0105-02
🏷️ FDA NDC (as labeled) 42961-105-02 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 42961-105-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
42961 labeler · 105 product · 02 package
Package marketed since
Jul 20, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4296110502 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42961-105-02
Product NDC 42961-105
11-digit billing NDC 42961010502
UNII U6WSN5SQ1Z
SPL Set ID a6c5906d-8f04-42f7-885f-e7490ec6b5bc
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-20
Route ORAL
Dosage form LOZENGE
Substance ZINC GLUCONATE
Why two NDCs? The FDA registers this code as 42961-105-02 — 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 → 42961-0105-02. 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 oral lozenge containing zinc gluconate. Homeopathic products are marketed based on traditional homeopathic practice rather than being evaluated by the FDA for effectiveness. In homeopathic tradition, zinc gluconate is commonly referenced in cold remedy formulations. Homeopathic products are prepared through specific dilution and preparation methods according to homeopathic principles.

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 eachPer 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
42961-0105-02 You're viewing this Main listing 20 PACKET in 1 PACKAGE / 1 LOZENGE in 1 PACKET 2023-07-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold Eeze 2 [hp_X] 73598-1242-01 JHK 25 lozenges — — FDA listed —
Medique Cold Eeze 2 [hp_X] 47682-0478-73 Unifirst 25 lozenges — — FDA listed —
First Aid Direct Cold-EEZE Cold Remedy 2 [hp_X]this 42961-0105-02 Cintas 20 lozenges — — 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color white
ShapeOval
ImprintP
Size23 mm
ScoringNot scored
FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 BUC5I9595W
    A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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

The official label also statesInactive ingredients corn syrup, glycine, natural flavors, sucrose

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

LabelerCintas Corporation
Labeler code42961
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from Cintas Corporation labeler code 42961

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 or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

⏱️ Dosage and Administration 72 words ▾

Directions take one lozenge at the onset of symptoms dissolve entire lozenge in mouth do not chew do not swallow whole do not eat or drink for 15 minutes after use repeat every 2-4 hours until symptoms subside Adults 18 years and over: do not exceed 6 lozenges per day Children 12 to under 18 years: do not exceed 4 lozenges per day Children under 12 years: ask a doctor before use

⚠️ Warnings 116 words ▾

Warnings Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

When using this product do not take on an empty stomach (to avoid possible minor stomach upset) Stop use and ask your doctor if symptoms persist more than 7 days If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 30 words ▾

Active ingredient (per lozenge) Zinc Gluconate 2X HPUS† (2.3%) (13.3 mg zinc) †The letters 'HPUS' indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients corn syrup, glycine, natural flavors, sucrose

🎯 Purpose 3 words ▾

Purpose Cold remedy

📄 Do Not Use 25 words ▾

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms

📄 Ask a Doctor or Pharmacist Before Use If 29 words ▾

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

📄 When Using This Product 17 words ▾

When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask your doctor if symptoms persist more than 7 days

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a healthcare professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 18 words ▾

Other information store in a cool, dry place after opening best if used within 6 months after opening

📄 Questions or Comments 5 words ▾

Questions? 1-800-327-2704 m-F 8am-5pm EST

📄 Package Label / Principal Display Panel 35 words ▾

Principal Display Panel Cold-EEZE® Cold Remedy Lozenge Zinc Gluconate Homeeopathic NATURAL CHERRY FLAVOR Formulated to reduce the duration of the common cold when taken at the first sign of symptoms. 20 Lozenges per box PDP

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 First Aid Direct Cold-EEZE Cold Remedy (this brand).

Top reported reactions

Fatigue173
Diarrhoea118
Nausea102
Urinary Tract Infection81
Dyspnoea77
Asthenia76
Pain75

Age at onset

Neonate10
Infant1
Child7
Adolescent7
Adult117
Elderly152

Reporter sex

1,543 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization505
Death92
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 237 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

First Aid Direct Cold-EEZE Cold Remedy Zinc Gluconate 2 [hp_X]/1 LOZENGE 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 Cintas Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cintas 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.
← 42961-0104-02 · Cintas 42961-0109-02 · Cintas →
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.