CVP Sterile Eye Drops Tetrahydrozoline HCl .05 g/100mL Solution/ Drops
by Salado Sales, Inc. · 1 BOTTLE, DROPPER in 1 BOX (57243-068-01) / 15 mL in 1 BOTTLE, DROPPER
NDC 57243-0068-01
🏷️ FDA NDC (as labeled)
57243-068-01
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)
57243-068-01
Product NDC
57243-068
11-digit billing NDC
57243006801
RxCUI
1052943
UNII
0YZT43HS7D
UPC
0761706165003
Application #
M018
SPL Set ID
31a216f8-28e9-ec8f-e063-6394a90aec49
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-01-01
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 57243-068-01 — 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 → 57243-0068-01. 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.
🏭 Manufacturer & labeler
LabelerSalado Sales, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code57243
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio17 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
📖 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?
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.
💬 Questions about Tetrahydrozoline HCl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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 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.
💲 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/100mL 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 | — |
| 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/100mLthis 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
🏛️
2024
On the market since
Jan 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.
🔬 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 Tetrahydrozoline HCl — the ingredient across all brands.
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 57243-0068-01 You're viewing this | 1 BOTTLE, DROPPER in 1 BOX (57243-068-01) / 15 mL in 1 BOTTLE, DROPPER | 2024-01-01 | Active |
🧭 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 FDA registers it as 57243-068-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57243-0068-01, written without dashes as 57243006801. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 57243-0068-01, the first segment (57243) is the labeler code FDA assigned to Salado Sales, Inc.; the middle segment (0068) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Salado Sales, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Salado Sales, 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.
📄 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
🎯 Indications and Usage ▾
Uses relieves redness of the eye due to minor eye irritations
⏱️ Dosage and Administration ▾
Directions Instill 1 or 2 drops in the affected eye(s) up to four 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 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 ▾
Active ingredient Tetrahydrozoline HCL 0.05%
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
🎯 Purpose ▾
Purpose Redness reliever
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 ↗
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.