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Oasis Tears PF Preservative-Free Lubricant Eye Glycerin .25 g/100mL Solution/ Drops — NDC 42126-6400-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oasis Tears PF Preservative-Free Lubricant Eye Glycerin .25 g/100mL Solution/ Drops — NDC 42126-6400-1 (Billing 42126-6400-01)

by OASIS Medical, Inc. · 1 BOTTLE, DISPENSING in 1 CARTON / 10 mL in 1 BOTTLE, DISPENSING

This is a package of Oasis Tears PF Preservative-Free Lubricant Eye Glycerin .25 g/100mL Solution/ Drops from OASIS Medical, Inc., marketed since Jan 2015 and currently FDA-listed. It is this product's only package size.

NDC 42126-6400-01
🏷️ FDA NDC (as labeled) 42126-6400-1 billing pads the package 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 42126-6400-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
42126 labeler · 6400 product · 1 package
Package marketed since
Jan 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4212664001 3
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.) · FDA recall D-0525-2026
Lots / codes: Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26. · reported May 20, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Glycerin (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH) · FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.) · FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
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) 42126-6400-1
Product NDC 42126-6400
11-digit billing NDC 42126640001
RxCUI 310541, 1598052
UNII PDC6A3C0OX
Application # M018
SPL Set ID 640f95f4-c2e8-48ad-ad40-f76bbaddb0dc
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect 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 2015-01-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance GLYCERIN
Quick answers
  • RxCUI (RxNorm): 310541
Why two NDCs? The FDA registers this code as 42126-6400-1 — 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 → 42126-6400-01. 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 Non-Standardized Chemical Allergen class.

Pharmacologic class Non-Standardized Chemical Allergen
Drug family (ATC) Enemas, Other drugs for constipation
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

🧪 What is this product?

Oasis Tears PF is an over-the-counter eye lubricant solution sold as preservative-free liquid drops for use in the eye. The active ingredient is glycerin, a humectant commonly used in eye drops to help lubricate the eye surface and relieve dryness or irritation. This product is formulated under FDA's OTC monograph rules for ophthalmic lubricants rather than as an individually approved application.

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 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.
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
42126-6400-01 You're viewing this Main listing 1 BOTTLE, DISPENSING in 1 CARTON / 10 mL in 1 BOTTLE, DISPENSING 2015-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oasis Tears PF Preservative-Free Lubricant Eye .25 g/100mLthis 42126-6400-01 OASIS 1 bottle — — FDA listed —
Oasis TEARS PF PLUS Preservative-Free Lubricant Eye .25 g/100mL 42126-6500-01 OASIS 1 bottle — — FDA listed —
Viva Hydration Boost 2.5 mg/mL 51801-0016-10 Nomax 10 ml — — FDA listed —
Dry Eye Relief Sterile Lubricant Eye Drops 2.5 mg/mL 59262-0803-11 Similasan 1 bottle — — FDA listed —
WE FRESH Lubricating Eye Drops 2.5 mg/mL 62144-0011-00 Oculus 1 bottle — — FDA listed —
Clear Eyes Nighttime 2.5 mg/mL 67172-0505-15 Prestige 1 bottle — — FDA listed —
Rain Daily Hydration and Comfort For Dry Eyes 2.5 mg/mL 79662-0003-10 Rain 1 bottle — — FDA listed —
Hydropure Lubricating Eye Drops 2.5 mg/mL 84227-0851-10 OTE 1 bottle — — FDA listed —
Moisture Oyster 2.5 mg/mL 87105-0100-10 Moisture 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

🏛️
2015
On the market since
Jan 2015
📍
2026
Currently FDA-listed
11 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerOASIS Medical, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code42126
First marketedJan 2015
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from OASIS Medical, Inc. labeler code 42126

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 🧪 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 50 words ▾

Uses For the temporary relief of burning and irritation due to dryness of the eye For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun For use as a protectant against further irritation or to relieve dryness of the eye

⏱️ Dosage and Administration 12 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) as needed.

⚠️ Warnings 102 words ▾

Warnings For external use only Do not use If solution changes color or becomes cloudy If you are sensitive to any ingredient in this product When using this product To avoid contamination do not touch tip of container to any surface Replace cap after using Discard 90 days after opening Stop use and ask a doctor if You experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other Information protect from light and freezing. store between 41°F (5°C) and 77°F (25°C).

🧪 Active Ingredient 4 words ▾

Active Ingredients Glycerin (0.25%)

🧪 Inactive Ingredients 15 words ▾

Inactive Ingredients Sodium hyaluronate, sodium chloride, sodium hydroxide, sodium phosphate dibasic, sodium phosphate monobasic, water

🎯 Purpose 4 words ▾

Purpose lubricant Eye Drops

📄 Do Not Use 20 words ▾

Do not use If solution changes color or becomes cloudy If you are sensitive to any ingredient in this product

📄 When Using This Product 25 words ▾

When using this product To avoid contamination do not touch tip of container to any surface Replace cap after using Discard 90 days after opening

📄 Stop Use and Ask a Doctor If 33 words ▾

Stop use and ask a doctor if You experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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 15 words ▾

Questions, or to report an adverse event call (800) 631-7180 or or log onto www.oasismedical.com

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton OASIS TEARS ® LUBRICANT EYE DROPS PRESERVATIVE-FREE STERILE 10mL/0.33FL OZ Bottle PF NDC 42126-6400-1 PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 OASIS Medical, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
OASIS Medical, 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.
← 42126-6310-01 · OASIS 42126-6500-01 · OASIS →
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.