Home › NDC Lookup › Ingredients › Glycerin, Naphazoline Hydrochloride › 48201-0107-01
Colirio Oftal-Mycin Glycerin, Naphazoline hydrochloride .25 g/100mL; .012 g/100mL Solution/ Drops — NDC 48201-0107-01 package photo

Colirio Oftal-Mycin Glycerin, Naphazoline hydrochloride .25 g/100mL; .012 g/100mL Solution/ Drops

by Grandall Distributing Co., Inc. · 1 BOTTLE, DROPPER in 1 BOX (48201-107-01) / 15 mL in 1 BOTTLE, DROPPER
NDC 48201-0107-01
🏷️ FDA NDC (as labeled) 48201-107-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 10, 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, Naphazoline Hydrochloride (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 · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0414-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 48201-107-01
Product NDC 48201-107
11-digit billing NDC 48201010701
RxCUI 1046700
UNII PDC6A3C0OX, MZ1131787D
UPC 0348201016131, 0348201016155
Application # M018
SPL Set ID 31aa07e9-0cc9-2a77-e063-6394a90a4b9d
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 2024-01-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 48201-107-01 — 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 → 48201-0107-01. 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.

🏭 Manufacturer & labeler

LabelerGrandall Distributing Co., Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code48201
First marketedJan 2024
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.

🩺 Clinical

🧪 What is this product?

Colirio Oftal-Mycin Glycerin is an over-the-counter eye drop solution marketed under FDA's OTC monograph rules. It contains glycerin, which is typically used as a lubricant and protectant for the eye surface, and naphazoline hydrochloride, a decongestant commonly used in eye drops to help reduce redness and minor irritation. This product is applied directly to the eye as drops.

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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • 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 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • 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.

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

The official label also statesbenzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

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
Foster and Thrive Redness Relief Eye Drops .012 g/100mL; .25 g/100mL 70677-1161-01 Strategic 1 bottle $0.101 — Availability likely —
GNP Eye Drops Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 46122-0606-05 AmerisourceBergen 1 bottle $0.105 — Discontinued —
Leader Eye Drops Redness Relief .25 g/100mL; .012 g/100mL 70000-0010-01 Cardinal 1 bottle $0.105 — Availability likely —
Walgreens Redness Relief Eye Drops 15mL .25 g/100mL; .012 g/100mL 00363-4548-01 Walgreen 1 bottle — — FDA listed —
Pure Eyes Sterile Eyes .1 mg/mL; 2.5 mg/mL 20146-7000-01 SAMSON 1 bottle — — FDA listed —
Signature Care Eye Drops Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 21130-0703-01 Better 1 bottle — — FDA listed —
Kroger Eye Drops Redness Relief .25 g/100mL; .012 g/100mL 30142-0573-01 The 1 bottle — — FDA listed —
Meijer Redness Relief .012 g/100mL; .25 g/100mL 41250-0846-01 Meijer 1 bottle — — FDA listed —
Xpect Industrial Eye Relief .012 g/100mL; .25 g/100mL 42961-0255-01 Cintas 1 bottle — — FDA listed —
Colirio Ojo De Aguila Eye Drops .25 g/100mL; .012 g/100mL 48201-0106-01 Grandall 1 bottle — — FDA listed —
Colirio Oftal-Mycin .25 g/100mL; .012 g/100mLthis 48201-0107-01 Grandall 1 bottle — — FDA listed —
Discount Drug Mart Redness Relief Eye Drops .25 g/100mL; .012 g/100mL 53943-0074-01 Discount 1 bottle — — FDA listed —
Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 55651-0620-01 KC 1 bottle — — FDA listed —
Clear Eyes Redness Relief Handy Pocket Pal .00012 mg/mL; .0025 mg/mL 67172-0796-01 Prestige 1 bottle — — Discontinued —
Clear Eyes Redness Relief .12 mg/mL; 2.5 mg/mL 67172-0797-01 Prestige 1 bottle — — FDA listed —
Harris Teeter Redness Relief Eye Drops .25 g/100mL; .012 g/100mL 69256-0979-01 Harris 1 bottle — — FDA listed —
Equate Redness and Dry Eye Relief Eye Drops .25 g/100mL; .012 g/100mL 79903-0012-01 Wal-Mart 1 bottle — — FDA listed —
Equate Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 79903-0362-01 Walmart 1 bottle — — FDA listed —
Equaline Redness Relief Lubricant Eye Drops .25 g/100mL; .012 g/100mL 83455-0213-01 United 1 bottle — — FDA listed —
Code Red Eye Drops Micro 20 mg/8mL; .96 mg/8mL 83817-0102-01 4 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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
48201-0107-01 You're viewing this 1 BOTTLE, DROPPER in 1 BOX (48201-107-01) / 15 mL in 1 BOTTLE, DROPPER 2024-01-01 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 48201-107-01, 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: 48201-0107-01, written without dashes as 48201010701. 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 48201-0107-01, the first segment (48201) is the labeler code FDA assigned to Grandall Distributing Co., Inc.; the middle segment (0107) 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 Grandall Distributing Co., Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Grandall Distributing Co., 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 37 words ▾

Uses relieves redness of the eye due to minor eye irritations for use as a protectant against further irritation or to relieve dryness of the eye temporarily relieves burning and irritation due to dryness of the eye

⏱️ Dosage and Administration 15 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

⚠️ Warnings 112 words ▾

Warnings For external use only Do not use this product if solution changes color or becomes cloudy Ask a doctor before use if you have narrow angle glaucoma When using this product do not touch tip of container to any surface to avoid contamination replace cap after using overuse may cause more redness of the eye pupils may become enlarged temporarily Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens symptoms last for more than 72 hours Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

🧪 Active Ingredient 7 words ▾

Active Ingredients Glycerin 0.25% Naphazoline hydrochloride 0.012%

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

🎯 Purpose 5 words ▾

Purpose Lubricant and redness reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 48201-0106-01 · Grandall 48201-0301-11 · GRANDALL →
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.