Home › NDC Lookup › Ingredients › Lubricant Eye Drops › 64108-0212-65
MINIDROPS Lubricant eye drops 6 mg/mL; 14 mg/mL Liquid, 65 vials — NDC 64108-0212-65 package photo

MINIDROPS Lubricant eye drops 6 mg/mL; 14 mg/mL Liquid, 65 vials

by Optics Laboratory, Inc · 65 VIAL, SINGLE-USE in 1 BOX (64108-212-65) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10)
NDC 64108-0212-65
🏷️ FDA NDC (as labeled) 64108-212-65 billing pads the product segment with a zero
This package
Contains65 vials Pack sizes4 compare ↓
Also comes in: 5 vials 64108-0212-13 5 ml 64108-0212-10 30 vials 64108-0212-12
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 64108-212-65
Product NDC 64108-212
11-digit billing NDC 64108021265
RxCUI 359969, 1046287
UNII FZ989GH94E, 532B59J990
Application # M018
SPL Set ID c13c5f91-50df-471c-a7c9-1747a2ac1250
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1991-04-01
Route OPHTHALMIC
Dosage form LIQUID
Substance POVIDONE, UNSPECIFIED; POLYVINYL ALCOHOL
GCN Seq No 030016
GCN 87031
HICL code 038595
Ingredient (HICL) Polyvinyl Alcohol/Povidone/Pf
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 OPTICS MINI DROPS
FDB brand name Optics Mini Drops
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 64108-212-65 — 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 → 64108-0212-65. 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

LabelerOptics Laboratory, Inc
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code64108
First marketedApr 1991
Product typeHuman Otc Drug
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 OPTICS MINI DROPS Ingredient Polyvinyl Alcohol/Povidone/Pf
🧪 What is this product?

Minidrips Lubricant Eye Drops is an over-the-counter liquid eye drop product sold under the FDA's OTC monograph rule for lubricating eye drops. It contains polyvinyl alcohol and povidone, which are lubricating agents typically used to relieve dryness and irritation of the eye surface. These ingredients function by coating and moisturizing the eye, similar to natural tears. This product is designed to be applied directly to the eye as needed.

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.

🧪 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.

  • 0.9 mg / 1 mL 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.
  • 97.1 mg / 1 mL 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.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesSODIUM CHLORIDE, WATER (PURIFIED)

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 systemPer mLPer 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.
Try another pack size: 5 vials 5 ml 30 vials
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
REFRESH Classic 14 mg/mL; 6 mg/mL 00023-0506-01 Allergan, 30 vials $0.306 — Availability likely —
Refresh Classic 14 mg/mL; 6 mg/mL 50090-2358-01 A-S 30 vials — — FDA listed —
Minidrops 6 mg/mL; 14 mg/mLthis 64108-0212-65 Optics 65 vials — — 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

🏛️
1991
On the market since
Apr 1991
📍
2026
Currently FDA-listed
35 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 MINIDROPS (this brand).

Top reported reactions

Eye Irritation5
Eye Pain4
Ocular Hyperaemia4
Eye Infection3
Eye Swelling3
Nausea3
Pain3

Age at onset

Elderly5

Reporter sex

39 reports
Male · 26%
Female · 74%

Serious outcomes

Hospitalization4
Disabling1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 0
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 NDCDescription Marketing startStatus
64108-0212-12 30 VIAL, SINGLE-USE in 1 BOX (64108-212-12) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-01 Active
64108-0212-13 5 VIAL, SINGLE-USE in 1 BOX (64108-212-13) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-01 Active
64108-0212-65 You're viewing this 65 VIAL, SINGLE-USE in 1 BOX (64108-212-65) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-01 Active
64108-0212-10 .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-01 Active

Pack size FAQ

What quantity is in NDC 64108-0212-65?
NDC 64108-0212-65 contains 65 vials — 65 vial, single-use in 1 box / .5 ml in 1 vial, single-use.
What is the difference between NDC 64108-0212-65 and NDC 64108-0212-13?
Both are MINIDROPS Lubricant eye drops 6 mg/mL; 14 mg/mL Liquid — the drug itself is identical. NDC 64108-0212-65 is the 65 vials package, while NDC 64108-0212-13 is the 5 vials package.
What NDC number is used to bill for this package of MINIDROPS Lubricant eye drops 6 mg/mL; 14 mg/mL Liquid?
Bill NDC 64108-0212-65 — the 11-digit billing format is 64108021265. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 64108-212-65, 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: 64108-0212-65, written without dashes as 64108021265. 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 64108-0212-65, the first segment (64108) is the labeler code FDA assigned to Optics Laboratory, Inc; the middle segment (0212) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (65) 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 Optics Laboratory, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 5 vials (64108-0212-13), 5 ml (64108-0212-10), 30 vials (64108-0212-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Optics Laboratory, 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 33 words ▾

INDICATIONS AND USE SECTION USES FOR TEMPORARY RELIEF OF BURNING AND IRRITATION DUE TO DRYNESS OF THE EYE FOR USE AS A PROTECTANT AGAINST FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE

⏱️ Dosage and Administration 28 words ▾

DOSAGE AND ADMINISTRATION SECTION DIRECTIONS TWIST OFF TAB COMPLETELY TO OPEN. INSTILL 1 TO 2 DROPS IN THE AFFECTED EYE(S) AS NEEDED. DISCARD DROPPER AND DO NOT REUSE.

⚠️ Warnings 83 words ▾

WARNINGS SECTION WARNINGS DO NOT USE IF THE SINGLE-DOSE DROPPER IS NOT INTACT. TO AVOID CONTAMINATION, DO NOT TOUCH TIP OF DROPPER TO ANY SURFACE. ONCE OPENED, DISCARD.

IF YOU EXPERIENCE EYE PAIN, CHANGES IN VISION, CONTINUED REDNESS OR IRRITATION OF THE EYE, OR IF THE CONDITIONS WORSENS OR PERSISTS FOR MORE THAN 72 HOURS, DISCONTINUE USE AND CONSULT A DOCTOR. IF SOLUTION CHANGES COLOR OR BECOMES CLOUDY, DO NOT USE OTHER INFORMATION STORE AT ROOM TEMPERATURE 15-30 DEGREES C (59-86 DEGREES F)

🧪 Active Ingredient 8 words ▾

ACTIVE INGREDIENTS SECTION POVIDONE 0.6% POLYVINYL ALCOHOL 1.4%

🧪 Inactive Ingredients 7 words ▾

INACTIVE INGREDIENTS SECTION SODIUM CHLORIDE, WATER (PURIFIED)

🎯 Purpose 4 words ▾

PURPOSE SECTION EYE LUBRICANT

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 64097-0001-01 · Alternacare 64108-0313-01 · Optics →
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.