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Gel-Kam Mint Stannous Fluoride 1 mg/g Gel, Dentifrice

by Colgate Oral Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON (0126-0192-93) / 122 g in 1 TUBE
NDC 00126-0192-93
🏷️ FDA NDC (as labeled) 0126-0192-93 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0126-0192-93
Product NDC 0126-0192
11-digit billing NDC 00126019293
NCPDP billing unit GM — per gram (weight)
RxCUI 237847, 750088
UNII 3FTR44B32Q
UPC 0038341192931
Application # M021
SPL Set ID 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-01-01
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance STANNOUS FLUORIDE
GPI-14 88402030004010
GPI class Gel-Kam
GCN Seq No 002625
GCN 07540
HICL code 001128
Ingredient (HICL) Stannous Fluoride
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D2
Therapeutic class — intermediate (HIC2) Drugs Acting On Teeth
HIC3 code D2A
Therapeutic class — specific (HIC3) Fluoride Preparations
AHFS code 34:04.00.00
AHFS class Nutritional Supplements
FDB label name GEL-KAM 0.4% DENTAL GEL
FDB brand name Gel-Kam
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0126-0192-93 — a 4-4-2 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 labeler segment → 00126-0192-93. 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 Caries prophylactic agents class.

Drug family (ATC) Caries prophylactic agents
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

LabelerColgate Oral Pharmaceuticals, Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code00126
First marketedJan 1990
Product typeHuman Otc Drug
Portfolio16 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

Label name GEL-KAM 0.4% DENTAL GEL Ingredient Stannous Fluoride
🧪 What is this product?

Gel-Kam Mint is an over-the-counter toothpaste gel that contains stannous fluoride, a form of fluoride commonly used in dental care products. Stannous fluoride is typically used to help strengthen tooth enamel and reduce tooth sensitivity. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for nonprescription oral care products rather than undergoing individual product 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.

💊 What it looks like

FlavorBerry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.

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

The official label also statesflavor, glycerin, hydroxyethylcellulose

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gel-Kam Fruit and Berry 1 mg/g 00126-0165-93 Colgate 1 tube — — FDA listed —
Gel-Kam Mint 1 mg/gthis 00126-0192-93 Colgate 1 tube — — FDA listed —
Enamelon Preventive Treatment .004 g/g 48783-0500-40 Premier 1 tube — — FDA listed —
Just For Kids .969 mg/g 48878-4020-03 Solventum 1 tube — — FDA listed —
Just For Kids .969 mg/g 48878-4070-03 Solventum 1 tube — — FDA listed —
Ionite H .4 mg/100g 53045-0270-04 Dharma 122 g — — FDA listed —
Ionite H .4 mg/100g 53045-0271-04 Dharma 122 g — — FDA listed —
Kids Choice .12 g/120g 63783-0005-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0006-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0008-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0009-04 Massco 120 g — — FDA listed —
Doctors Choice .12 g/120g 63783-0011-04 Massco 120 g — — FDA listed —
Kids Choice .12 g/120g 63783-0015-04 Massco 120 g — — FDA listed —
Gelato Homecare .116 g/120g 68400-0201-04 Mycone 120 g — — FDA listed —
Gelato Homecare .116 g/120g 68400-0205-04 Mycone 120 g — — 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

🏛️
1990
On the market since
Jan 1990
📍
2026
Currently FDA-listed
36 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.

🔬 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 Gel-Kam Mint (this brand).

Top reported reactions

Oral Discomfort5
Dyspnoea4
Oral Disorder4
Oral Pain4
Anaemia3
Dysphagia3
Fatigue3

Age at onset

Child1
Adult2
Elderly1

Reporter sex

43 reports
Male · 47%
Female · 53%

Serious outcomes

Hospitalization18
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00126-0192-93 You're viewing this 1 TUBE in 1 CARTON (0126-0192-93) / 122 g in 1 TUBE 1990-01-01 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 — Not published for this NDC No photo available yet for this listing.
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 0126-0192-93, 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: 00126-0192-93, written without dashes as 00126019293. 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 00126-0192-93, the first segment (00126) is the labeler code FDA assigned to Colgate Oral Pharmaceuticals, Inc.; the middle segment (0192) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (93) 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 Colgate Oral Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Colgate Oral Pharmaceuticals, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Uses helps protect against cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

⏱️ Dosage and Administration 111 words ▾

Directions adults and children 12 years of age or older: use after regular brushing and flossing shake excess water from your toothbrush and cover bristles with gel brush thoroughly keep on your teeth for one minute and then spit out do not swallow do not rinse, eat or drink for 30 minutes use once a day for cavity protection use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physician make sure all sensitive areas are covered by using a toothbrush or a cotton swab supervise children until capable of using without supervision children under 12 years of age: consult a dentist or physician

⚠️ Warnings 72 words ▾

Warnings Do not use this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician. Stop use and ask a doctor if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 84 words ▾

Other information this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use this product may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist do not use if embossed seal on tube is broken or missing to open tube, remove cap and pierce foil seal with point of cap keep tightly closed when not in use store at controlled room temperature 68-77°F (20-25°C)

🧪 Active Ingredient 6 words ▾

Active ingredient Stannous fluoride 0.4% (w/w)

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients flavor, glycerin, hydroxyethylcellulose

🎯 Purpose 3 words ▾

Purposes Anticavity/Sensitivity Relief

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00126-0165-93 · Colgate 00126-0272-16 · Colgate →
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.