HomeNDC LookupIngredientsTetrahydrozoline Hcl › 83324-0340-15
Quality Choice Eye Drops Redness Relief Tetrahydrozoline HCl .05 g/100mL Solution/ Drops — NDC 83324-0340-15 package photo

Quality Choice Eye Drops Redness Relief Tetrahydrozoline HCl .05 g/100mL Solution/ Drops

by Chain Drug Marketing Assoc., Inc. · 1 BOTTLE, DROPPER in 1 CARTON (83324-340-15) / 15 mL in 1 BOTTLE, DROPPER
NDC 83324-0340-15
🏷️ FDA NDC (as labeled) 83324-340-15 billing pads the product 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 →
⚠️
Other active recalls for Tetrahydrozoline Hcl (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0413-2026
Class II · Jun 13, 2023 — CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. (K.C. Pharmaceuticals, Inc) · FDA recall D-0897-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 83324-340-15
Product NDC 83324-340
11-digit billing NDC 83324034015
NCPDP billing unit ML — per mL (volume)
RxCUI 1052943
UNII 0YZT43HS7D
UPC 0635515903777
Application # M018
SPL Set ID 38d2bc34-c6f0-a09c-e063-6394a90a69e1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-26
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TETRAHYDROZOLINE HYDROCHLORIDE
GCN Seq No 007771
GCN 32311
HICL code 015909
Ingredient (HICL) Tetrahydrozoline Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6D
Therapeutic class — specific (HIC3) Eye Vasoconstrictors (Otc Only)
AHFS code 52:32.00.00
AHFS class Vasoconstrictors
FDB label name QC EYE DROPS 0.05%
FDB brand name Eye Drops
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 83324-340-15 — 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 → 83324-0340-15. 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.

🏷️ RxNorm drug class

This medicine belongs to the Sympathomimetics, plain class.

Drug family (ATC) Sympathomimetics, plain, Sympathomimetics used as decongestants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerChain Drug Marketing Assoc., Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio4 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

Label name QC EYE DROPS 0.05% Ingredient Tetrahydrozoline Hcl
📖 What it is MedlinePlus · NLM

Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves the redness you see, but it doesn't treat the underlying cause of the irritation. Think of it as a short-term fix to take the red out. If something is genuinely botheri...
  • What exactly does this eye drop do — does it actually fix what's irritating my eye?
  • No — you should remove your contact lenses before putting in the drops. The solution can be absorbed by soft contacts, which can affect the lens and potentially irritate your eye....
  • Can I wear my contact lenses while using these drops?
📖 Read our full Tetrahydrozoline Ophthalmic guide →
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.

🧪 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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

The official label also statesbenzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

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 DailyMedingredient 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.

💲 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 $0.097 $1.45 / 15 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 $0.097 $0.097
Flat over the last 3 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Pharmacy Eye Drops Original Formula .05 g/100mL 24385-0075-05 AmerisourceBergen 1 bottle $0.097 Discontinued
Foster and Thrive Original Formula Eye Drops .05 g/100mL 70677-1159-01 Strategic 1 bottle $0.097 Availability likely
Quality Choice Eye Drops Redness Relief .05 g/100mLthis 83324-0340-15 Chain 1 bottle $0.097 Availability likely
Sunmark Eye Drops Original Formula .05 g/100mL 49348-0037-29 Strategic 1 bottle $0.115 FDA listed +19%
Walgreens Eye Drops Original 15mL and twin pack .05 g/100mL 00363-4550-01 Walgreens 1 bottle FDA listed
Kroger Eye Drops Original .05 g/100mL 30142-0574-01 The 1 bottle FDA listed
TopCare Health Original Eye Drops .05 g/100mL 36800-0858-01 Topco 1 bottle FDA listed
HEB Original Eye Drops .05 g/100mL 37808-0577-01 HEB 1 bottle FDA listed
Meijer Redness Relief .05 g/100mL 41250-0814-01 Meijer 1 bottle FDA listed
GoodSense Eye Drops Original Formula .05 g/100mL 50804-0141-01 Geiss, 1 bottle FDA listed
CAREALL Eyedrops Original .5 mg/mL 51824-0039-05 New 15 ml FDA listed
Discount Drug Mart Eye Drops Original .05 g/100mL 53943-0073-01 Discount 1 bottle FDA listed
Family Wellness Original Redness Relief Eye Drops .05 g/100mL 55319-0907-01 Family 1 bottle FDA listed
Medics Choice Eye Drops Original Redness Reliever .5 mg/mL 55651-0005-01 KC 1 bottle FDA listed
Original Redness Reliever .05 g/100mL 55651-0063-01 KC 1 bottle FDA listed
DG Original Eye Drops .05 g/100mL 55910-0363-01 Dolgencorp 1 bottle FDA listed
CVP Sterile Eye Drops .05 g/100mL 57243-0068-01 Salado 1 bottle FDA listed
Preferred Plus Pharmacy Redness Relief Eye Drops .05 g/100mL 61715-0212-01 Kinray 1 bottle FDA listed
Best Choice Eye Drops Original .05 g/100mL 63941-0139-01 Valu 1 bottle FDA listed
Redness Reliever, Circle K .5 mg/mL 66715-5429-04 Lil' 1 bottle FDA listed
Lil Drug Store Eye Drops Redness Reliever .5 mg/mL 66715-6832-04 Lil 1 bottle FDA listed
CIRCLE K sterile eye drops .05 g/100mL 66715-8882-01 Lil' 1 bottle FDA listed
Lil Drug Store Sterile Eye Drops Redness Reliever .05 g/100mL 66715-8883-01 Lil' 1 bottle FDA listed
Winco Original Formula Eye Drops .05 g/100mL 67091-0310-15 WinCo 1 bottle FDA listed
Equate Eye Drops .5 mg/mL 67172-0281-01 Prestige 1 bottle Discontinued
Equate Eye Drops .5 mg/mL 67172-0282-01 Prestige 1 bottle Discontinued
Harris Teeter Eye Drops Original .05 g/100mL 69256-0977-01 Harris 1 bottle FDA listed
Visine Red Eye Comfort .5 mg/mL 69968-0355-01 Kenvue 1 bottle FDA listed
Equate Original Eye Drops .05 g/100mL 79903-0158-05 Walmart, 1 bottle FDA listed
Original Redness Reliever .05 g/100mL 79903-0363-01 Walmart 1 bottle FDA listed
Equaline Sterile Eye Drops .05 g/100mL 83455-0210-01 United 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 Quality Choice Eye Drops Redness Relief (this brand).

Top reported reactions

Fatigue3
Alanine Aminotransferase Increased2
Aspartate Aminotransferase Increased2
Asthenia2
Blood Alkaline Phosphatase Increased2
Dysgeusia2
Fall2

Age at onset

Elderly1

Reporter sex

13 reports
Male · 54%
Female · 46%

Serious outcomes

Hospitalization7
Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83324-0340-15 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (83324-340-15) / 15 mL in 1 BOTTLE, DROPPER 2025-06-26 Active

📄 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 11 words

Uses relieves redness of the eye due to minor eye irritations

⏱️ Dosage and Administration 15 words

Directions Instill 1 or 2 drops in the affected eye(s) up to four times daily

⚠️ Warnings 127 words

Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding ask a health professional before use Keep out of reach of chlidren If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 5 words

Active ingredient Tetrahydrozoline HCL 0.05%

🧪 Inactive Ingredients 14 words

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

🎯 Purpose 3 words

Purpose Redness reliever

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.