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GenTeal Tears NIGHT-TIME mineral oil, white petrolatum .03 g/g; .94 g/g Ointment, 1 tube — NDC 0065-0518-01 (Billing 00065-0518-01)

by Alcon Laboratories, Inc. · 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

This is a package of 1 tube of GenTeal Tears NIGHT-TIME mineral oil, white petrolatum .03 g/g; .94 g/g Ointment from Alcon Laboratories, Inc., marketed since Sep 2019 and currently FDA-listed; retail pharmacies pay about $2.48 per g (NADAC). It is this product's only package size.

NDC 00065-0518-01
🏷️ FDA NDC (as labeled) 0065-0518-01 billing pads the labeler 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

NDC database record

One package, one record: these facts belong to NDC 0065-0518-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0065 labeler · 0518 product · 01 package
Package marketed since
Sep 5, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0300650518017
Medicaid fills, this package
33,509 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1320-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-0518-01
Product NDC 0065-0518
11-digit billing NDC 00065051801
NCPDP billing unit GM — per gram (weight)
RxCUI 706820
UNII T5L8T28FGP, 4T6H12BN9U
UPC 0300650518017
Application # M018
SPL Set ID 9d5998a7-4f59-4293-87da-8419650a524d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-05
Route OPHTHALMIC
Dosage form OINTMENT
Substance MINERAL OIL; PETROLATUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86209902904220
GPI class GenTeal Tears Night-Time
GCN Seq No 064246
GCN 99952
HICL code 002215
Ingredient (HICL) Mineral Oil/Petrolatum,White
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 Q6Y
Therapeutic class — specific (HIC3) Eye Preparations, Miscellaneous (Otc)
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name GENTEAL TEARS SEVERE 3-94% OIN
FDB brand name Genteal Tears Severe
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 064246
  • GCN: 99952
  • GPI-14 (Medi-Span): 86209902904220
  • HICL (First Databank): 002215
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 706820
Why two NDCs? The FDA registers this code as 0065-0518-01 — 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 → 00065-0518-01. 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 Softeners, emollients class.

Drug family (ATC) Softeners, emollients
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

Label name GENTEAL TEARS SEVERE 3-94% OIN Ingredient Mineral Oil/Petrolatum,White
🧪 What is this product?

GenTeal Tears Night-Time is an over-the-counter ophthalmic ointment marketed under FDA's OTC monograph rules for eye lubricants. It contains mineral oil and white petrolatum, both occlusive moisturizing agents that are typically used to coat and protect the eye surface. This type of product is commonly used to relieve dry eye discomfort, particularly at night when tear production naturally decreases.

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 gPer package
Retail pharmacies payNADAC · weekly $2.480 $8.68 / 3.5 g
Medicaid paysCMS SDUD · 12 mo $3.97 $13.89 / 3.5 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
Dec 2021 Dec 2023 Mar 2026 Sep 2026 $2.592 $2.210
▲ Up 8% over the last 17 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00065-0518-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE 2019-09-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
GenTeal Tears NIGHT-TIME .03 g/g; .94 g/gthis 00065-0518-01 Alcon 1 tube $2.480 — Availability likely —
Systane Nighttime 30 mg/g; 940 mg/g 00065-0509-35 Alcon 1 tube $2.485 — Availability likely +0%
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

🏛️
2019
On the market since
Sep 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.

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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesAnhydrous liquid lanolin

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.

Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00065
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio55 products on file

More NDCs from Alcon Laboratories, Inc. labeler code 00065

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 📦 Storage and Handling 🧪 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 16 words ▾

Uses for use as a lubricant to prevent further irritation to relieve dryness of the eye.

⏱️ Dosage and Administration 25 words ▾

Directions Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 12 words ▾

Other information store at 8° – 27° C (46° – 80° F).

🧪 Inactive Ingredients 5 words ▾

Inactive ingredient: Anhydrous liquid lanolin

🎯 Purpose 13 words ▾

Active ingredients Purpose Mineral oil 3 % Lubricant White petrolatum 94 % Lubricant

📄 Do Not Use 13 words ▾

Do not use if you are sensitive to any ingredient in this product

📄 When Using This Product 17 words ▾

When using this product do not touch tip of container to any surface replace cap after using

📄 Stop Use and Ask a Doctor If 34 words ▾

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 19 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 11 words ▾

Questions? In the U.S., call toll-free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) [email protected]

📄 Package Label / Principal Display Panel 162 words ▾

PRINCIPAL DISPLAY PANEL Severe DRY EYE SYMPTOM RELIEF OINTMENT GenTeal ® Tears LUBRICANT EYE OINTMENT GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort. NIGHT-TIME OINTMENT Long-lasting Night-time Relief STERILE 3.5 g (0.12 FL OZ) Alcon ® TAMPER EVIDENT: For your protection, do not use if carton security seal is damaged or missing at the time of purchase. Distributed by: ALCON LABORATORIES, INC., 6201 South Freeway Fort Worth, Texas 76134 USA Country of Origin: Belgium 1635962-0723 LOT: EXP.: Please read this carton carefully and keep for future reference.

Severe DRY EYE SYMPTOM RELIEF OINTMENT GenTeal® Tears LUBRICANT EYE OINTMENT GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort. NIGHT-TIME OINTMENT Long-lasting Night-time Relief STERILE 3.5 g (0.12 FL OZ) Alcon TAMPER EVIDENT: For your protection, do not use if carton security seal is damaged or missing at the time of purchase. Distributed by: ALCON LABORATORIES, INC., 6201 South Freeway Fort Worth, Texas 76134 USA Country of Origin: Spain 3601067 01-0724

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
33.5K
Units reimbursed last 4 qtrs
128.5K
Gross reimbursed last 4 qtrs
$509.9K
Avg / prescription
$15.22
Avg / unit
$3.9687
Latest quarter Q1 2026
10KRx
Medicaid pays / g
$3.9687
gross reimbursed
vs
NADAC / g
$2.4796
acquisition cost
=
Spread
+$1.4891
+60% 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 ⓘ
86% FFS 14% MCO
Fee-for-service · 28,806 Rx Managed care · 4,703 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 5,093 units · 65.2 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 3,346 units · 58.3 per 100k residents MN Wisconsin: 2,566 units · 43.4 per 100k residents WI Michigan: 1,771 units · 17.6 per 100k residents MI New York: 93,757 units · 479 per 100k residents NY Vermont: 319 units · 49.3 per 100k residents VT New Hampshire: 308 units · 22.0 per 100k residents NH Oregon: 329 units · 7.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,936 units · 60.4 per 100k residents IA Illinois: 1,897 units · 15.1 per 100k residents IL Indiana: 2,098 units · 30.6 per 100k residents IN Ohio: 5,219 units · 44.3 per 100k residents OH Pennsylvania: 1,722 units · 13.3 per 100k residents PA New Jersey: 3,084 units · 33.2 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 2,993 units · 151 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 473 units · 5.4 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 420 units · 5.7 per 100k residents AZ New Mexico: 413 units · 19.5 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 245 units · 23.8 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 505 units · 35.2 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.4479
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
🏆 Top states by units · per 100k residents
1 New York 479 /100k
2 Nebraska 151 /100k
3 Washington 65.2 /100k
4 Iowa 60.4 /100k
5 Minnesota 58.3 /100k
6 Vermont 49.3 /100k
7 Ohio 44.3 /100k
8 Wisconsin 43.4 /100k
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 NIGHT-TIME (this brand).

Top reported reactions

Eye Irritation33
Vision Blurred24
Eye Pain20
Dry Eye16
Lacrimation Increased14
Ocular Hyperaemia10
Dyspnoea8

Age at onset

Elderly1

Reporter sex

206 reports
Male · 21%
Female · 79%

Serious outcomes

Hospitalization37
Death13
Life-threatening6
Disabling5
Reports over time (by year) — tap or hover for the count & year
2025 2026 4 1
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.
← 00065-0509-35 · Alcon 00065-0741-14 · Alcon →
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.