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Oftal-Mycin Lubricant Ophthalmic Light Mineral, White Petrolatum 83 g/100g; 15 g/100g Ointment, 3.5 g — NDC 48201-0301-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oftal-Mycin Lubricant Ophthalmic Light Mineral, White Petrolatum 83 g/100g; 15 g/100g Ointment, 3.5 g — NDC 48201-301-11 (Billing 48201-0301-11)

by GRANDALL DISTRIBUTING, LLC · 3.5 g in 1 BOTTLE

This is a package of 3.5 g of Oftal-Mycin Lubricant Ophthalmic Light Mineral, White Petrolatum 83 g/100g; 15 g/100g Ointment from GRANDALL DISTRIBUTING, LLC, marketed since Dec 2024 and currently FDA-listed. It is this product's only package size.

NDC 48201-0301-11
🏷️ FDA NDC (as labeled) 48201-301-11 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 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

NDC database record

One package, one record: these facts belong to NDC 48201-301-11 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
48201 labeler · 301 product · 11 package
Package marketed since
Dec 18, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4820130111 4
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 48201-301-11
Product NDC 48201-301
11-digit billing NDC 48201030111
RxCUI 746083
UNII B6E5W8RQJ4, N6K5787QVP
Application # M014
SPL Set ID 298db04a-21a9-e46e-e063-6294a90acee2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-18
Route OPHTHALMIC
Dosage form OINTMENT
Substance WHITE PETROLATUM; LIGHT MINERAL OIL
Quick answers
  • RxCUI (RxNorm): 746083
Why two NDCs? The FDA registers this code as 48201-301-11 — 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 → 48201-0301-11. 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 Softeners, emollients class.

Drug family (ATC) Softeners, emollients
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?

Oftal-Mycin Lubricant is an over-the-counter ophthalmic ointment containing white petrolatum and light mineral oil. Both ingredients function as lubricants and emollients, and are commonly used in eye ointments to help soothe and protect the eye surface. This type of product is typically applied directly to the eye to provide moisture and reduce dryness or irritation. It is marketed under FDA's over-the-counter monograph rules for lubricating eye products.

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 gPer 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
48201-0301-11 You're viewing this Main listing 3.5 g in 1 BOTTLE 2024-12-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LubriFresh PM 150 mg/g; 830 mg/g 00904-7540-12 Major 1 tube $1.687 — Availability likely —
LubriFresh PM 150 mg/g; 830 mg/g 11716-7540-01 Hanlim 1 tube — — FDA listed —
Oftal-Mycin Lubricant Ophthalmic 83 g/100g; 15 g/100gthis 48201-0301-11 GRANDALL 3.5 g — — FDA listed —
Vis Guard Lubricant EyeOintment PM 830 mg/g; 150 mg/g 73057-0510-11 Ulai 1 tube — — 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
Dec 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.

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 884C3FA9HE
    Lanolin alcohol is a waxy substance derived from sheep's wool. It functions as an emollient and emulsifier in medicines, helping blend oil and water-based ingredients while softening the product's texture.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesLANOLIN ALCOHOLS

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.

Manufacturer & labeler

LabelerGRANDALL DISTRIBUTING, LLC
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code48201
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from GRANDALL DISTRIBUTING, LLC labeler code 48201

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

USES for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun may be used as a protectant against further irritation

⏱️ Dosage and Administration 37 words ▾

DIRECTIONS wash your hands pull down the lower lid of the affected eye and gently apply a small amount (1/4 inch) of ointment to the inside of eyelid, every 3-4 hours or as directed by a doctor

⚠️ Warnings 55 words ▾

WARNINGS For external use only When using this product to avoid contamination do not touch tip of container to any surface keep tube tightly closed 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

📦 Storage and Handling 20 words ▾

OTHER INFORMATION store away from heat protect from freezing use before expiration date on the tube store at 15-25°C (59-77°F)

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENT Light Mineral Oil 15% White Petrolatum 83%

🧪 Inactive Ingredients 4 words ▾

INACTIVE INGREDIENT LANOLIN ALCOHOLS

🎯 Purpose 3 words ▾

PURPOSE EYE LUBRICANT

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Questions or Comments 5 words ▾

QUESTIONS OR COMMENTS? CALL 1800-344-2422

📄 Package Label / Principal Display Panel 1 words ▾

UC

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) ✓ 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 GRANDALL DISTRIBUTING, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GRANDALL DISTRIBUTING, 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.
← 48201-0107-01 · Grandall 48251-0113-01 · Symrise →
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.