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STASIS Ferric Sulfate 3150 mg/15mL Solution, 15 mL — NDC 10129-0031-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

STASIS Ferric Sulfate 3150 mg/15mL Solution, 15 mL — NDC 10129-031-01 (Billing 10129-0031-01)

by Gingi-Pak a Division of the Belport · 15 mL in 1 BOTTLE, GLASS

This is a package of 15 mL of STASIS Ferric Sulfate 3150 mg/15mL Solution from Gingi-Pak a Division of the Belport, marketed since Jun 1987 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 10129-0031-01
🏷️ FDA NDC (as labeled) 10129-031-01 billing pads the product segment with a zero
This package
Contains15 mL Pack sizes2 compare ↓
Main listing for product 10129-031 · Also comes in: 40 ml 10129-031-02
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) 10129-031-01
Product NDC 10129-031
11-digit billing NDC 10129003101
RxCUI 630489
UNII 3HWS7HF5XD
SPL Set ID 758b87c1-886f-4316-e053-2a91aa0ac7be
Established class (EPC) Parenteral Iron Replacement; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Chemical class Iron
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-06-26
Route DENTAL, PERIODONTAL, SUBGINGIVAL
Dosage form SOLUTION
Substance FERRIC SULFATE
Quick answers
  • RxCUI (RxNorm): 630489
Why two NDCs? The FDA registers this code as 10129-031-01 — 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 → 10129-0031-01. 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?

STASIS Ferric Sulfate is a dental solution containing ferric sulfate that is applied directly to the gums and below the gum line during dental and periodontal procedures. Ferric sulfate is commonly used in dentistry as a hemostatic agent, meaning it helps control bleeding by promoting blood clotting at the site of application. This product is an unapproved drug marketed without an FDA-approved 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.

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.
Try another pack size: 40 ml
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
10129-0031-01 You're viewing this Main listing 15 mL in 1 BOTTLE, GLASS 1987-06-26 — Active
10129-0031-02 10129-031-02 40 mL in 1 BOTTLE, GLASS 1987-06-26 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 15 mL — 15 ml in 1 bottle, glass.
How does this package differ from NDC 10129-0031-02?
Both are STASIS Ferric Sulfate 3150 mg/15mL Solution — the drug itself is identical. This page's package is the 15 mL one, while NDC 10129-0031-02 is the 40 ml package.
What NDC number is used to bill for this package of STASIS Ferric Sulfate 3150 mg/15mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stasis 3150 mg/15mLthis 10129-0031-01 Gingi-Pak 15 ml — — 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

🏛️
1987
On the market since
Jun 1987
📍
2026
Currently FDA-listed
39 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.

  • 0.45 mL / 15 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.

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

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

LabelerGingi-Pak a Division of the Belport
Labeler code10129
First marketedJun 1987
Product typeHuman Otc Drug
Portfolio14 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 2 words ▾

Uses Uses

⏱️ Dosage and Administration 2 words ▾

Directions Directions

⚠️ Warnings 2 words ▾

Warning Warnings

📦 Storage and Handling 2 words ▾

Storage Storage

🧪 Active Ingredient 4 words ▾

Active Ingredient Active Ingredient

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient Inactive ingredients

🎯 Purpose 2 words ▾

Purpose Purpose

📄 Ask a Doctor Before Use If 12 words ▾

Stop use and ask a doctor Stop use and ask a doctor

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children Keep out of reach of children

⚠️ Precautions 66 words ▾

Precautions Precautions Temporary discoloration of tissue may occur for 24 to 48 hours. (Reassure patient that discoloration will disappear). IT IS NOT RECOMMENDED THAT FERRIC SULFATE SOLUTIONS SUCH AS STASIS BE USED IN COMBINATION WITH EPINEPHRINE OR EPINEPHRINE IMPREGNATED RETRACTION MATERIALS BECAUSE LONG TERM AND POSSIBLE PERMANENT STAINING MIGHT OCCUR. Stains on hands and clothing may generally be removed with the use of 3% Hydrogen Peroxide.

📄 Package Label / Principal Display Panel 16 words ▾

Principal Display-Stasis 15 cc Principal Display-Stasis 15 cc

Principal Display-Stasis 40 cc Principal Display-Stasis 40 cc

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 STASIS (this brand).

Top reported reactions

Nephroangiosclerosis11
Tubulointerstitial Nephritis11
Acute Kidney Injury10
Acidosis9
Hypokalaemia9
Anaemia6
Drug Intolerance6

Age at onset

Adult4
Elderly9

Reporter sex

78 reports
Male · 41%
Female · 59%

Serious outcomes

Hospitalization30
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 5 2
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

Over-the-counter (OTC) 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 ✓ 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 "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 Gingi-Pak a Division of the Belport. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 40 ml (10129-0031-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Gingi-Pak a Division of the Belport 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.
← 10129-0019-03 · Gingi-Pak 10129-0032-03 · Gingi-Pak →
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.