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Equaline Eye Drops A.C. tetrahydrozoline HCl, zinc sulfate .05 g/100mL; .25 g/100mL Solution — NDC 41163-540-01 (Billing 41163-0540-01)

by United Natural Foods, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

This is a package of Equaline Eye Drops A.C. tetrahydrozoline HCl, zinc sulfate .05 g/100mL; .25 g/100mL Solution from United Natural Foods, Inc., marketed since Mar 2023 and currently FDA-listed. It is this product's only package size.

NDC 41163-0540-01
🏷️ FDA NDC (as labeled) 41163-540-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Tetrahydrozoline Hcl, Zinc Sulfate (different manufacturers) — 1 · 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-0409-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41163-540-01
Product NDC 41163-540
11-digit billing NDC 41163054001
RxCUI 1043249
UNII 0YZT43HS7D, 89DS0H96TB
UPC 0041163251144
Application # M018
SPL Set ID f5f894f0-1ab0-4cad-e053-2995a90a7cba
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 2023-03-22
Route OPHTHALMIC
Dosage form SOLUTION
Substance TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Quick answers
  • RxCUI (RxNorm): 1043249
Why two NDCs? The FDA registers this code as 41163-540-01 — 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 → 41163-0540-01. 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.

Clinical

📖 About the active ingredient: Tetrahydrozoline Hydrochloride; Zinc Sulfate MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

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

Read the full MedlinePlus article ↗
🧪 What is this product?

Equaline Eye Drops A.C. is an over-the-counter liquid eye drop product formulated according to FDA guidelines for this drug category. It contains tetrahydrozoline hydrochloride, a decongestant commonly used to temporarily reduce redness in the eyes, and zinc sulfate, an astringent mineral salt typically included to help relieve eye irritation. This combination is meant to address minor eye discomfort and redness from common causes such as allergies or irritation.

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
41163-0540-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER 2023-03-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Eye Drops Seasonal Relief 15mL .05 g/100mL; .25 g/100mL 00363-4545-01 Walgreen 1 bottle — — FDA listed —
Signature Care Eye Drops A.C. .05 g/100mL; .25 g/100mL 21130-0755-01 Better 1 bottle — — FDA listed —
Kroger Eye Drops Seasonal Relief .05 g/100mL; .25 g/100mL 30142-0349-01 Kroger 1 bottle — — FDA listed —
Topcare Health Ultra Itch Relief Astringent Eye Drops .05 g/100mL; .25 g/100mL 36800-0855-01 Topco 1 bottle — — FDA listed —
HEB A.C. Eye Drops .05 g/100mL; .25 g/100mL 37808-0757-01 HEB 1 bottle — — FDA listed —
Equaline Eye Drops A.C. .05 g/100mL; .25 g/100mLthis 41163-0540-01 United 1 bottle — — FDA listed —
Meijer Seasonal Itching and Redness Relief .05 g/100mL; .25 g/100mL 41250-0598-01 Meijer 1 bottle — — FDA listed —
GoodSense Eye Drops Irritation Relief .05 g/100mL; .25 g/100mL 50804-0121-01 Geiss, 1 bottle — — FDA listed —
Discount Drug Mart Eye Drops A.C. .05 g/100mL; .25 g/100mL 53943-0062-01 Discount 1 bottle — — FDA listed —
Medics Choice Eye Drops Seasonal Relief 2.5 mg/mL; .5 mg/mL 55651-0024-01 KC 1 bottle — — FDA listed —
Best Choice Eye Drops A.C. .05 g/100mL; .25 g/100mL 63941-0838-01 Best 1 bottle — — FDA listed —
Winco Irritation Relief Eye 50 mg/100mL; 250 mg/100mL 67091-0283-15 WinCo 1 bottle — — FDA listed —
CVS Astringent Eye 50 mg/100mL; 250 mg/100mL 69842-0611-01 CVS 1 bottle — — FDA listed —
Visine A.C. Itchy Eye Relief .5 mg/mL; 2.5 mg/mL 69968-0366-01 Kenvue 1 bottle — — FDA listed —
CareOne Itchy Relief Eye Drops 15mL .25 g/100mL; .05 g/100mL 72476-0011-01 Retail 1 bottle — — Discontinued —
Quality Choice Eye Drops Irritation Relief .05 g/100mL; .25 g/100mL 83324-0190-14 Quality 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

🏛️
2023
On the market since
Mar 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerUnited Natural Foods, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code41163
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio13 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.

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 16 words ▾

Use for temporary relief of discomfort and redness of the eye due to minor eye irritation

⏱️ Dosage and Administration 15 words ▾

Directions Instill 1 to 2 drops in the affected eye(s) up to 4 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 children.

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

🧪 Active Ingredient 6 words ▾

Active ingredients Tetrahydrozoline HCl....0.05% Zinc sulfate.....0.25%

🧪 Inactive Ingredients 14 words ▾

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

🎯 Purpose 6 words ▾

Purposes Tetrahydrozoline HCl......Redness reliever Zinc sulfate......Astringent

📄 Ask a Doctor Before Use If 11 words ▾

Ask a doctor before use if you have narrow angle glaucoma

📄 When Using This Product 48 words ▾

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 33 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

📄 Other Information 6 words ▾

Other information store at 15º-30ºC (59º-86ºF)

📄 Package Label / Principal Display Panel 1 words ▾

box

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 Equaline Eye Drops A.C. (this brand).

Top reported reactions

Eye Pain1

Reporter sex

1 reports
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 United Natural Foods, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
United Natural Foods, Inc. 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.
← 41163-0536-30 · United 41163-0553-89 · United →
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.