Artificial Tears 70 1 mg/mL; 2 mg/mL; 3 mg/mL Solution/ Drops, 15 mL
by AvPAK · 15 mL in 1 BOTTLE (50268-043-15)
NDC 50268-0043-15
🏷️ FDA NDC (as labeled)
50268-043-15
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 24, 2026 · 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 · Apr 23, 2025 — cGMP deviations and lack of assurance of sterility. (BRS Analytical Services, LLC) · FDA recall D-0404-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
50268-043-15
Product NDC
50268-043
11-digit billing NDC
50268004315
NCPDP billing unit
ML — per mL (volume)
RxCUI
900138
UNII
7SA290YK68, PDC6A3C0OX, 3NXW29V3WO
Application #
M018
SPL Set ID
f18bebf2-1936-658f-e053-2a95a90a5012
Established class (EPC)
Plasma Volume Expander; Non-Standardized Chemical Allergen
Mechanism of action
Osmotic Activity
Physiologic effect
Increased Intravascular Volume; Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class
Allergens; Glycerol
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-01-05
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
DEXTRAN 70; GLYCERIN; HYPROMELLOSES
GPI-14
86201000002000
GCN Seq No
047660
GCN
13064
HICL code
022019
Ingredient (HICL)
Dextran/Hypromellose/Glycerin
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
Q6T
Therapeutic class — specific (HIC3)
Artificial Tears
AHFS code
52:92.00.00
AHFS class
Eent Drugs, Miscellaneous
FDB label name
ARTIFICIAL TEARS 0.1-0.2-0.3%
FDB brand name
Artificial Tears
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50268-043-15 — 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 → 50268-0043-15. 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 Viscoelastic substances class.
Drug family (ATC)
Viscoelastic substances
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
LabelerAvPAK
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code50268
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio348 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 ARTIFICIAL TEARS 0.1-0.2-0.3% Ingredient Dextran/Hypromellose/Glycerin
🧪 What is this product?
Artificial Tears is an over-the-counter eye drop solution containing dextran 70, glycerin, and hypromelloses. These ingredients are commonly used together to lubricate and moisturize the eye surface, helping to soothe dryness and irritation. Dextran acts as a thickening agent that helps the drops coat the eye, while glycerin and hypromelloses function as lubricants and humectants to retain moisture on the ocular surface. This product is applied directly to the eye as needed for temporary relief of dry eye symptoms.
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 Artificial Tears?
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.
-
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 M4I0D6VV5M
Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
-
UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
-
UNII 02F3473H9O
A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
-
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
-
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.
-
UNII 86Q357L16B
Zinc chloride is a mineral salt used as a buffer and pH regulator in medications. It helps maintain the chemical stability and proper acidity level of the drug formulation.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc 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 | $0.404 | $6.06 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.7302 | $10.95 / 15 ml |
| 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
Flat over the last 2 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 |
|---|---|---|---|---|---|---|
| Artificial Tears 70 1 mg/mL; 2 mg/mL; 3 mg/mLthis 50268-0043-15 | AvPAK | 15 ml | $0.404 | — | Availability likely | — |
| GenTeal Tears (Moderate) 70 1 mg/mL; 2 mg/mL; 3 mg/mL 00065-0426-36 | Alcon | 1 bottle | $0.481 | — | Availability likely | +19% |
| Genteal Tears 70 1 mg/mL; 2 mg/mL; 3 mg/mL 50090-5050-00 | A-S | 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
Jan 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 50268-0043-15, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.4K
Units reimbursed last 4 qtrs
53.3K
Gross reimbursed last 4 qtrs
$38.9K
Avg / prescription
$11.36
Avg / unit
$0.7302
Latest quarter Q4 2025
180Rx
Medicaid pays / mL
$0.7302
gross reimbursed
vs
NADAC / mL
$0.4038
acquisition cost
=
Spread
+$0.3264
+81% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 1,258 Rx Managed care · 2,166 Rx
State Medicaid map
Units reimbursed · per 100k residents
2.697.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 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 Artificial Tears — the ingredient across all brands.
Top reported reactions
Age at onset
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 |
|---|---|---|---|
| 50268-0043-15 You're viewing this | 15 mL in 1 BOTTLE (50268-043-15) | 2023-01-05 | 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
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun May be used as a protectant against further irritation
⏱️ Dosage and Administration ▾
Directions Shake well before use Instill 1 or 2 drops in the affected eye(s) as needed
⚠️ Warnings ▾
Warnings For use in the eyes only
📦 Storage and Handling ▾
Other Information store at room temperature
🧪 Active Ingredient ▾
Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant
🧪 Inactive Ingredients ▾
Inactive ingredients: benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.
🎯 Purpose ▾
Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant
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.