Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Quality Choice Eye Drops Irritation Relief Tetrahydrozoline HCl, Zinc sulfate .05 g/100mL; .25 g/100mL Solution/ Drops — NDC 83324-190-14 (Billing 83324-0190-14)
by Quality Choice · 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER
This is a package of Quality Choice Eye Drops Irritation Relief Tetrahydrozoline HCl, Zinc sulfate .05 g/100mL; .25 g/100mL Solution/ Drops from Quality Choice, marketed since Aug 2024 and currently FDA-listed. It is this product's only package size.
NDC 83324-0190-14
🏷️ FDA NDC (as labeled)
83324-190-14
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 83324-190-14 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 83324 labeler · 190 product · 14 package
- Package marketed since
- Aug 11, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0635515995055
- FDA record last changed
- Jul 24, 2026
🚨
Active recall for this product.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0409-2026
Lots / codes: Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26; · reported Apr 8, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
83324-190-14
Product NDC
83324-190
11-digit billing NDC
83324019014
NCPDP billing unit
ML — per mL (volume)
RxCUI
1043249
UNII
0YZT43HS7D, 89DS0H96TB
UPC
0635515995055
Application #
M018
SPL Set ID
1f682079-6e91-e14b-e063-6394a90a3f12
Established class (EPC)
Copper Absorption Inhibitor
Physiologic effect
Decreased Copper Ion Absorption
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-08-11
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
86409902202010
GCN Seq No
048812
GCN
14744
HICL code
003413
Ingredient (HICL)
Tetrahydrozoline Hcl/Zinc Sulf
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 IRRITATION RELIEF
FDB brand name
Eye Drops Irritation Relief
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 048812
- GCN: 14744
- GPI-14 (Medi-Span): 86409902202010
- HICL (First Databank): 003413
- AHFS class code: 52:32.00.00
- RxCUI (RxNorm): 1043249
Why two NDCs?
The FDA registers this code as 83324-190-14 — 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 → 83324-0190-14. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name QC EYE DROPS IRRITATION RELIEF Ingredient Tetrahydrozoline Hcl/Zinc Sulf
🧪 What is this product?
Quality Choice Eye Drops Irritation Relief is an over-the-counter liquid eye drop product made under FDA's OTC monograph rules for eye drops. It contains tetrahydrozoline hydrochloride, a decongestant typically used to reduce redness in the eyes, and zinc sulfate, an astringent mineral salt commonly used in eye drops for minor irritation. This combination is typically used to provide temporary relief of minor eye redness and irritation from causes such as dust, smoke, or dry conditions.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about Tetrahydrozoline HCl, Zinc sulfate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 83324-0190-14 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER | 2024-08-11 | — | Active |
Therapeutic equivalents
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
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 chloride, sodium citrate.
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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerQuality Choice
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio3 products on file
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- Sunscreen for Kids SPF 50 Avebonzone, Homosalate, Octisalate 30 mg/g; 120 mg/g; 50 mg/g Spray NDC 83324-184-05
- Sport Sunscreen SPF 30 Avebonzone, Homosalate, Octisalate 30 mg/g; 100 mg/g; 50 mg/g Spray NDC 83324-185-05
- MILK OF MAGNESIA ORIGINAL magnesium hydroxide 1200 mg/15mL Liquid NDC 83324-188-12
- Quality Choice Artificial Tears Lubricant Eye Drops Polyvinyl alcohol, Povidone .5 g/100mL; .6 g/100mL Solution/ Drops NDC 83324-189-14
- Quality Choice Moisturizing Relief Eye Drops Dextran 70, Polyethylene glycol 400, Povidone, Tetrahydrozoline HCl 70 .1 g/100mL; .05 g/100mL; 1 g/100mL; 400 1 g/100mL Solution/ Drops NDC 83324-191-14
- Quality Choice Eye Wash Water 99.05 g/100mL Solution/ Drops NDC 83324-192-04
- Quality Choice Mucus Relief Guaifenesin 400 mg Tablet NDC 83324-194-50
- Quality Choice Mucus Relief DM DM Dextromethorphan Hydrobromide / Guaifenesin 20 mg; 400 mg Tablet NDC 83324-195-50
- Quality Choice Gas Relief Extra Strength Softgels Simethicone 125 mg Capsule, Liquid Filled NDC 83324-196-30
- Quality Choice Stool Softener DOCUSATE SODIUM 100 mg Capsule, Liquid Filled NDC 83324-197-01
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Ask a Doctor 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
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use for temporary relief of discomfort and redness of the eye due to minor eye irritation
⏱️ Dosage and Administration ▾
Directions Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
⚠️ Warnings ▾
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 lenses 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 children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
🧪 Active Ingredient ▾
Active ingredients Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate.
🎯 Purpose ▾
Purposes Redness reliever Astringent
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have narrow angle glaucoma
📄 When Using This Product ▾
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 lenses before using
📄 Stop Use and Ask a Doctor If ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
📄 Other Information ▾
Other information store at 15º-30ºC (59º-86ºF)
📄 Package Label / Principal Display Panel ▾
Quality Choice Eye Drops Irritation Relief 15mL Quality Choice Eye Drops Irritation Relief 15mL
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Quality Choice Eye Drops Irritation Relief (this brand).
Top reported reactions
Reporter sex
Female · 100%
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
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 Quality Choice. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Quality Choice 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.
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.