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GRAFCO APPLICATOR 45 CM Silver Nitrate 73.4314 mg; 24.4804 mg Stick, 1 stick — NDC 12165-300-01 (Billing 12165-0300-01)

by GF Health Products, Inc. · 1 STICK in 1 TUBE

This is a package of 1 stick of GRAFCO APPLICATOR 45 CM Silver Nitrate 73.4314 mg; 24.4804 mg Stick from GF Health Products, Inc., marketed since Apr 1949 and currently FDA-listed. It is this product's only package size.

NDC 12165-0300-01
🏷️ FDA NDC (as labeled) 12165-300-01 billing pads the product segment with a zero
Rx only 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 12165-300-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
12165 labeler · 300 product · 01 package
Package marketed since
Apr 19, 1949
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 1216530001 8
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 12165-300-01
Product NDC 12165-300
11-digit billing NDC 12165030001
NCPDP billing unit EA — each (per item)
RxCUI 1117536
UNII 95IT3W8JZE, RU45X2JN0Z
SPL Set ID d7622ce1-a327-4c81-b6c0-c9e8dbd39565
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1949-04-19
Route TOPICAL
Dosage form STICK
Substance SILVER NITRATE; POTASSIUM NITRATE
Quick answers
  • RxCUI (RxNorm): 1117536
Why two NDCs? The FDA registers this code as 12165-300-01 — 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 → 12165-0300-01. 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.

Clinical

🧪 What is this product?

This is an unapproved topical stick applicator containing silver nitrate and potassium nitrate. Silver nitrate is a caustic agent traditionally used to cauterize or remove certain skin lesions and growths. Potassium nitrate appears as a companion ingredient in this formulation. The product is applied directly to the skin surface and is marketed as a prescription medication, though it does not have current FDA approval.

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 eachPer 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
12165-0300-01 You're viewing this Main listing 1 STICK in 1 TUBE 1949-04-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Styptstix 38.21 mg/1; 12.74 mg 00404-1000-01 Henry 12 tubes — — FDA listed —
Grafco Applicator 15 Cm 38.21 mg/1; 12.74 mg 12165-0100-01 GF 100 sticks — — FDA listed —
Grafco Applicator 30 Cm 52.451 mg/1; 17.486 mg 12165-0200-03 GF 100 sticks — — FDA listed —
Grafco Applicator 45 Cm 73.4314 mg/1; 24.4804 mgthis 12165-0300-01 GF 1 stick — — FDA listed —
Silver Nitrate Applicators 25 mg/100mg; 75 mg/100mg 12870-0001-01 Arzol 10 packets — — FDA listed —
Grafco Silver Nitrate (75% Silver Nitrate, 25% Potassium Nitrate) 12.74 mg/1; 38.21 mg 51662-1611-01 HF 100 sticks — — FDA listed —
Avoca Flexible Caustic Applicator 30 mg/40mg 65875-0101-09 Bray 10 vials — — FDA listed —
Swabs 25 g/100mL; 75 g/100mL 68599-6303-08 McKesson 10 swabs — — 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

🏛️
1949
On the market since
Apr 1949
📍
2026
Currently FDA-listed
77 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

LabelerGF Health Products, Inc.
Labeler code12165
First marketedApr 1949
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from GF Health Products, Inc. labeler code 12165

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 📦 Storage and Handling 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

INDICATIONS AND USAGE: INDICATIONS: For cauterization of skin or mucous membrane and for removing warts and granulated tissue.

⏱️ Dosage and Administration 129 words ▾

DOSAGE AND ADMINISTRATION: Moisten the applicator tip with distilled, deionized or purified water and apply the silver nitrate to the affected area by holding, rubbing, or rotating the tip along the affected tissue. The strength of the action is controlled by the dilution with distilled, deionized or purified water. One silver nitrate applicator is generally sufficient for each application.

The action of the silver nitrate can be stopped by washing the area with saline solution (0.9% sodium chloride). Using saline solution to wet the applicator tips, or residual saline from wound flushing/washing will interfere with the action of silver nitrate resulting in cauterization failure. Only use distilled, deionized or purified water to wet applicator tips.

Blot dry wounds that have been flushed/washed with saline prior to applying silver nitrate.

💊 Dosage Forms and Strengths 7 words ▾

DOSAGE FORMS AND STRENGTHS: Stick: 98 mg

⛔ Contraindications 69 words ▾

CONTRAINDICATIONS: Silver salts stain tissue black due to deposition of reduced silver. The stain gradually disappears within a period of two weeks. Prolonged ingestion or absorption of silver compounds leads to deposition of silver in connective tissues, producing a slate-blue discoloration of the skin known as argyria. This discoloration may also appear on mucous membranes such as the margins of gums. The sclera of the eye is also stained.

⚠️ Warnings and Cautions 177 words ▾

WARNINGS AND PRECAUTIONS: WARNING: KEEP OUT OF REACH OF CHILDREN. The active ingredients are poisonous and may be fatal when ingested in sufficient doses. The symptoms include toxic gastroenteritis, which may lead to coma, convulsion, paralysis and profound alteration of respiration.

If poisoning occurs, immediately consult a physician. WARNING: DO NOT USE ON THE EYES. In case of eye contact, hold eyes open and immediately flush thoroughly with water for at least 15 minutes and consult a physician.

CAUTION: SILVER NITRATE IS A CAUSTIC SUBSTANCE. Chemical burns may result from inappropriate use of product. • Wear chemical resistant gloves while using this product. Wear other appropriate personal protective equipment as needed. • Take care to confine the silver nitrate to the area being treated by using an appropriate physical or chemical barrier to prevent staining or burning of untreated tissue. • Skin contact time with applicators should be minimal when used on thin delicate skin or neonates. • Avoid prolonged contact with skin or other surfaces since staining may occur.

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

📦 Storage and Handling 57 words ▾

STORAGE: Store in the closed package at room temperature in a dry place protected from light. Silver nitrate will oxidize and turn dark brown upon exposure to light, however this does not affect the product’s potency or utility. Exposure to moisture can cause the tip to break or loosen from the applicator. Store away from vaporous chemicals.

📄 Package Label / Principal Display Panel 7 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL: image description

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for GRAFCO APPLICATOR 45 CM (this brand).

Top reported reactions

Fatigue26
Diarrhoea23
On And Off Phenomenon23
Stoma Site Discharge22
Stoma Site Erythema20
Dyskinesia19
Hallucination19

Age at onset

Neonate2
Adult20
Elderly18

Reporter sex

237 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization103
Life-threatening10
Disabling3
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 26 4
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 GF Health Products, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GF Health Products, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 12165-0200-03 · GF 12213-0200-01 · NexAir →
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.