GenTeal Tears Severe Hypromellose 2910 (4000 MPA.S) .003 g/g Gel — NDC 0065-8064-01 (Billing 00065-8064-01)
by Alcon Laboratories, Inc. · 1 TUBE in 1 CARTON / 10 g in 1 TUBE
This is a package of GenTeal Tears Severe Hypromellose 2910 (4000 MPA.S) .003 g/g Gel from Alcon Laboratories, Inc., marketed since Dec 2019 and currently FDA-listed; retail pharmacies pay about $0.9037 per g (NADAC). It is this product's only package size.
NDC 00065-8064-01
🏷️ FDA NDC (as labeled)
0065-8064-01
billing pads the labeler 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 →
🚨
Active recall for this product.
Class II · Apr 21, 2026 — Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. (Alcon Research LLC) · FDA recall D-0492-2026
Lots / codes: Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027. · reported May 6, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Hypromellose (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 · Apr 21, 2026 — Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. (Alcon Research LLC) · FDA recall D-0491-2026
Class II · Dec 31, 2025 — Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. (Wizcure Pharmaa Private Limited) · FDA recall D-0347-2026
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)
0065-8064-01
Product NDC
0065-8064
11-digit billing NDC
00065806401
NCPDP billing unit
GM — per gram (weight)
UNII
RN3152OP35
UPC
0300658064011
Application #
M018
SPL Set ID
a57854fc-f3a2-4fbb-b718-cd06f87a721e
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-12-31
Route
OPHTHALMIC
Dosage form
GEL
Substance
HYPROMELLOSE 2910 (4000 MPA.S)
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
86200025004020
GPI class
GenTeal Severe
GCN Seq No
065846
GCN
27956
HICL code
008840
Ingredient (HICL)
Hypromellose
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
GENTEAL TEARS SEVERE 0.3% GEL
FDB brand name
Genteal Tears Severe
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 065846
- GCN: 27956
- GPI-14 (Medi-Span): 86200025004020
- HICL (First Databank): 008840
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 310932
Why two NDCs?
The FDA registers this code as 0065-8064-01 — a 4-4-2 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 labeler segment → 00065-8064-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 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 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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name GENTEAL TEARS SEVERE 0.3% GEL Ingredient Hypromellose
🧪 What is this product?
GenTeal Tears Severe Hypromellose is an over-the-counter eye gel containing hypromellose, a lubricating agent. Applied directly to the eye, it is typically used to relieve dryness and irritation of the eye surface. This product is marketed as an OTC monograph drug, meaning it follows FDA's established category rules for eye lubricants rather than undergoing individual product review.
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 1, 2026
💬 Questions about Hypromellose?
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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.904 | $9.04 / 10 g |
| Medicaid paysCMS SDUD · 12 mo | $2.22 | $22.17 / 10 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▲ Up 11% over the last 19 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.
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 |
|---|---|---|---|---|
| 00065-8064-01 You're viewing this Main listing | 1 TUBE in 1 CARTON / 10 g in 1 TUBE | 2019-12-31 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Systane 2910 (4000 MPA.S) 3 mg/g 00065-0474-01 | Alcon | 1 tube | $0.904 | — | Availability likely | — |
| GenTeal Tears Severe 2910 (4000 MPA.S) .003 g/gthis 00065-8064-01 | Alcon | 1 tube | $0.904 | — | Availability likely | — |
| VISTA Hypromellose Dry Eye Relief 2910 (50 MPA.S) .3 g/mL 77790-0002-10 | Red | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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 Sep 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 35V6A8JW8E
A chemical compound used as a buffer and pH regulator in medications. It helps maintain the proper acidity level of the medicine to improve stability and ensure the active ingredients work as intended.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII Y52BK1W96C
A chemical compound containing sodium and borate that acts as an oxidizing agent. In medicines, it serves as a preservative and antimicrobial, helping prevent bacterial and fungal growth in the product.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarbopol 980, phosphonic acid, purified water, sodium hydroxide, sodium perborate, and sorbitol
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 1, 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
LabelerAlcon Laboratories, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00065
First marketedDec 2019
Product typeHuman Otc Drug
Portfolio55 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 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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun as a protectant against further irritation or to relieve dryness of the eye
⏱️ Dosage and Administration ▾
Directions put 1 or 2 drops in the affected eye(s) as needed
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active ingredient Purpose Hypromellose 0.3%. Lubricant
🧪 Inactive Ingredients ▾
Inactive ingredients carbopol 980, phosphonic acid, purified water, sodium hydroxide, sodium perborate, and sorbitol
🎯 Purpose ▾
Active ingredient Purpose Hypromellose 0.3%. Lubricant
📄 Do Not Use ▾
Do not use if gel changes color or becomes cloudy if you are sensitive to any ingredient in this product
📄 When Using This Product ▾
When using this product do not touch tip of container to any surface replace cap after using
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for more than 72 hours
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions? In the U.S., call toll-free 1-800-757-9195 ( Mon-Fri 9AM-5PM CST) [email protected]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Severe DRY EYE SYMPTOM RELIEF GEL GenTeal ® Tears LUBRICANT EYE GEL GEL Delivers Long-lasting relief of dry eye symptoms STERILE 10 g (0.34 FL OZ) TAMPER EVIDENT: For your protection, use only if pull tab is intact at time of purchase. Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Lot/Exp Alcon 25368103 Severe DRY EYE SYMPTOM RELIEF GenTeal® Tears LUBRICANT EYE GEL GEL Delivers long-lasting relief of dry eye symptoms STERILE 10g (0.34 FL OZ) Active Ingredient: Hypromellose (0.3%) Uses: See carton for Uses.
Warnings: See carton for Warnings. When using this product do not touch tip of container to any surface. Replace cap after using.
Directions: Put 1 or 2 drops in the affected eye(s) as needed. Other Information: Store between 15°-25°C (59°-77°F). TAMPER EVIDENT: For your protection, use only if pull tab is intact at the time of purchase.
Distributed by: ALCON LABORATORIES, INC. 6201 South Freeway, Fort Worth, Texas 76134 USA ALCON 16027802
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 ↗
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 this package alone, 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 – Q1 2026 · 5 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
7.3K
Units reimbursed last 4 qtrs
70.2K
Gross reimbursed last 4 qtrs
$155.6K
Avg / prescription
$21.23
Avg / unit
$2.2167
Latest quarter Q1 2026
3.3KRx
Medicaid pays / g
$2.2167
gross reimbursed
vs
NADAC / g
$0.9037
acquisition cost
=
Spread
+$1.3130
+145% vs cost
What Medicaid paid per g (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 · 6,385 Rx Managed care · 943 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.8324
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 GenTeal Tears Severe (this brand).
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.
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.