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Regener-Eyes Ophthalmic Solution LITE XL Glycerin 4 mg/mL Solution/ Drops, 1 bottle — NDC 87354-001-01 (Billing 87354-0001-01)

by M & M PRODUCTS, L.L.C. · 1 BOTTLE in 1 CARTON / 1 mL in 1 BOTTLE

This is a package of 1 bottle of Regener-Eyes Ophthalmic Solution LITE XL Glycerin 4 mg/mL Solution/ Drops from M & M PRODUCTS, L.L.C., marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 87354-0001-01
🏷️ FDA NDC (as labeled) 87354-001-01 billing pads the product 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87354-001-01
Product NDC 87354-001
11-digit billing NDC 87354000101
RxCUI 2610311, 2610313
UNII PDC6A3C0OX
Application # M018
SPL Set ID 47ab9609-4291-30b2-e063-6394a90a421e
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 2026-02-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance GLYCERIN
Quick answers
  • RxCUI (RxNorm): 2610311
Why two NDCs? The FDA registers this code as 87354-001-01 — 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 → 87354-0001-01. 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?

Regener-Eyes Ophthalmic Solution LITE XL is an over-the-counter eye drop product containing glycerin. Glycerin is a humectant commonly used in eye drops to help lubricate and moisturize the eye surface. This product is marketed as an OTC monograph drug, meaning it follows established regulatory guidelines for its category rather than undergoing individual FDA review. It is typically used to provide temporary relief of dryness and irritation on the ocular surface.

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 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
87354-0001-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 1 mL in 1 BOTTLE 2026-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Regener-Eyes LITE 12 mg/3mL 82305-0006-01 Regenerative 3 bottles — — Discontinued —
Regener-Eyes Ophthalmic Solution LITE XL 4 mg/mLthis 87354-0001-01 M 1 bottle — — FDA listed —
Regener-Eyes Ophthalmic Solution LITE 4 mg/mL 87354-0003-01 M 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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

LabelerM & M PRODUCTS, L.L.C.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code87354
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio2 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 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 📋 Description 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 88 words ▾

Indications and Uses Uses: For the temporary relief of burning and irritation due to dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.

Indications Regener-Eyes® is formulated to provide temporary relief of burning and irritation due to dryness of the eye. Each product is preservative-free and can be used as a protectant against further irritation or to relieve dryness of the eye.

⏱️ Dosage and Administration 16 words ▾

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

⚠️ Warnings 79 words ▾

Warnings Warnings: External Use Only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

If solution changes color or becomes cloudy, do not use. Stop use and ask a doctor If: You experience 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 If swallowed, get medical help, or contact a Poison Control Center immediately.

🧪 Active Ingredient 6 words ▾

Active Ingredient Active ingredient Glycerin 0.4%

🧪 Inactive Ingredients 10 words ▾

Inactive Ingredients Inactive Ingredients Sterile Water, Tonicity Solution Sodium Chloride.

🎯 Purpose 4 words ▾

Purpose Purpose: Eye Lubricant

📋 Description 211 words ▾

Carton Labeling - Drug Facts and other Panels (Non-PDP) Drug Facts Active ingredient Glycerin 0.4% Purpose: Eye Lubricant Uses: For the temporary relief of burning and irritation due to dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings: External Use Only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

If solution changes color or becomes cloudy, do not use. Stop use and ask a doctor If: You experience 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 If swallowed, get medical help, or contact a Poison Control Center immediately. Directions Instill 1 or 2 drops in the affected eye (s) as needed. Inactive Ingredients Sterile Water, Tonicity Solution Sodium Chloride.

Other information Store at Room Temperature. Questions? (656) 225-2260 Indications Regener-Eyes® is formulated to provide temporary relief of burning and irritation due to dryness of the eye.

Each product is preservative-free and can be used as a protectant against further irritation or to relieve dryness of the eye.

📄 When Using This Product 6 words ▾

When Using Store at Room Temperature.

📄 Keep Out of Reach of Children 24 words ▾

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

📄 Package Label / Principal Display Panel 37 words ▾

Carton PDP - Front Panel - 5mL Proprietary Name: Regener-Eyes Ophthalmic Solutiion LITE XL Product Descriptor: Eye Lubricant Key Claims: To Relieve Dryness of the Eye Net Contents: 5mL LITE XL Label Regener-Eyes LITE XL Carton Artwork

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 — Not published for this NDC No photo available yet for this listing.
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 M & M PRODUCTS, L.L.C.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
M & M PRODUCTS, L.L.C. 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.
← 87353-0001-01 · Dongguan 87354-0002-01 · M →
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.