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TopCare Health Dry Eye Relief Eye Drops glycerin, hypromellose, polyethylene glycol 400 400 1 g/100mL; .2 g/100mL; .2 g/100mL Solution — NDC 36800-0845-01 package photo

TopCare Health Dry Eye Relief Eye Drops glycerin, hypromellose, polyethylene glycol 400 400 1 g/100mL; .2 g/100mL; .2 g/100mL Solution

by Topco Associates LLC · 1 BOTTLE, DROPPER in 1 CARTON (36800-845-01) / 15 mL in 1 BOTTLE, DROPPER
NDC 36800-0845-01
🏷️ FDA NDC (as labeled) 36800-845-01 billing pads the product segment with a zero
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

⚠️
Other active recalls for Glycerin, Hypromellose, Polyethylene Glycol 400 (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 13, 2023 — CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. (K.C. Pharmaceuticals, Inc) · FDA recall D-0898-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 36800-845-01
Product NDC 36800-845
11-digit billing NDC 36800084501
RxCUI 259581
UNII B697894SGQ, 3NXW29V3WO, PDC6A3C0OX
UPC 0036800361003
Application # M018
SPL Set ID 9c617e34-fc66-1a5b-e053-2995a90ace2c
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 2020-02-06
Route OPHTHALMIC
Dosage form SOLUTION
Substance POLYETHYLENE GLYCOL 400; HYPROMELLOSE, UNSPECIFIED; GLYCERIN
Why two NDCs? The FDA registers this code as 36800-845-01 — 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 → 36800-0845-01. 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 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.

🏭 Manufacturer & labeler

LabelerTopco Associates LLC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedFeb 2020
Product typeHuman Otc Drug
Portfolio408 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.

🩺 Clinical

🧪 What is this product?

TopCare Health Dry Eye Relief is an over-the-counter eye drop solution containing three lubricating agents: glycerin, hypromellose, and polyethylene glycol 400. These ingredients are commonly used together in artificial tear products to help moisturize and coat the surface of the eye. This product is formulated as an OTC monograph drug, meaning it follows FDA's established safety and use guidelines for its category rather than being individually approved through a new drug application.

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.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • 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.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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.

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

The official label also statesbenzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

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.
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
Sunmark Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 49348-0095-29 Strategic 1 bottle $0.160 — FDA listed —
GNP Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 46122-0605-05 AmerisourceBergen 1 bottle $0.169 — Discontinued —
Leader Dry Eye Relief Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 70000-0502-01 CARDINAL 1 bottle $0.169 — Availability likely —
Rite Aid Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 11822-1067-02 Rite 1 bottle — — FDA listed —
TopCare Health Dry Eye Relief Eye Drops 400 1 g/100mL; .2 g/100mL; .2 g/100mLthis 36800-0845-01 Topco 1 bottle — — FDA listed —
HEB Dry Eye Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 37808-0748-01 HEB 1 bottle — — FDA listed —
Meijer Dry Eye Relief .2 g/100mL; 400 1 g/100mL; .2 g/100mL 41250-0718-01 Meijer 1 bottle — — FDA listed —
Equate Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 49035-0280-01 Wal-Mart 2 bottles — — FDA listed —
Discount Drug Mart Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 53943-0032-01 Discount 1 bottle — — FDA listed —
Exchange Select Artificial Tears Lubricant Eye Drops 400 1 g/100mL; .2 g/100mL; .2 g/100mL 55301-0178-01 Army 1 bottle — — FDA listed —
Artificial Tears Lubricant Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 55651-0115-01 KC 1 bottle — — FDA listed —
DG Health Dry Eye Relief 400 1 g/100mL; .2 g/100mL; .2 g/100mL 55910-0362-01 Dolgencorp 1 bottle — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 57896-0181-05 Geri-Care 1 bottle — — FDA listed —
Core Values Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 63940-0035-01 Liberty 1 bottle — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 68071-4555-05 NuCare 15 mg — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 68788-7266-00 Preferred 1 bottle — — FDA listed —
Harris Teeter Eye Drops Artificial Tears .2 g/100mL; .2 g/100mL; 400 1 g/100mL 69256-0823-01 Harris 1 bottle — — FDA listed —
Crocodile Tears Lubricant Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 87522-0115-01 Crocodile 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
36800-0845-01 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (36800-845-01) / 15 mL in 1 BOTTLE, DROPPER 2020-02-06 Active

🧭 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 36800-845-01, 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: 36800-0845-01, written without dashes as 36800084501. 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 36800-0845-01, the first segment (36800) is the labeler code FDA assigned to Topco Associates LLC; the middle segment (0845) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates LLC 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 19 words ▾

Uses for protection against further irritation for temporary relief of burning and irritation due to dryness of the eye

⏱️ Dosage and Administration 21 words ▾

Directions instill 1 to 2 drops in the affected eye(s) as needed children under 6 years of age: ask a doctor

⚠️ Warnings 102 words ▾

Warnings For external use onl y Do not use this product if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface. Replace cap after using. 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 If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed , get medical help or contact a Poison Control Center (1-800-222-1222), right away.

🧪 Active Ingredient 12 words ▾

Active ingredients Glycerin ................... 0.2% Hypromellose ........... 0.2% Polyethylene glycol 400 ......1%

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

🎯 Purpose 6 words ▾

Purposes Glycerin.......................Lubricant Hypromellose..............Lubricant Polyethylene glycol 400.........Lubricant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 36800-0844-11 · Topco 36800-0846-07 · Topco →
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.