Leader Original Eye Drops Tetrahydrozoline HCl 0.05 g/100mL Solution/ Drops
by Cardinal Health · 1 BOTTLE, PLASTIC in 1 CARTON (70000-0454-1) / 15 mL in 1 BOTTLE, PLASTIC
NDC 70000-0454-01
🏷️ FDA NDC (as labeled)
70000-0454-1
billing pads the package segment with a zero
OTC
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🚨
Active recall for this product.
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
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
70000-0454-1
Product NDC
70000-0454
11-digit billing NDC
70000045401
NCPDP billing unit
ML — per mL (volume)
Application #
M018
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Mar 2026)
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
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 70000-0454-1 — a 5-4-1 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 package segment → 70000-0454-01. 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.
🏭 Manufacturer & labeler
LabelerCardinal Health
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code70000
Product typeHuman Otc Drug
Portfolio84 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 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?
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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.
💲 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 | $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
▲ Up 2% over the last 16 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
| 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 | — |
| Leader Original Eye Drops 0.05 g/100mLthis 70000-0454-01 | Cardinal | 1 bottle | $0.097 | — | Discontinued | — |
| 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
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70000-0454-01 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (70000-0454-1) / 15 mL in 1 BOTTLE, PLASTIC | 2019-02-19 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC The FDA label for this product carries no photos. |
| 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) | ✓ Available |
| 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 full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 70000-0454-1, 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: 70000-0454-01, written without dashes as 70000045401. 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 70000-0454-01, the first segment (70000) is the labeler code FDA assigned to Cardinal Health; the middle segment (0454) 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.
Who lists this product with the FDA?
Cardinal Health 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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.
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.