Home › NDC Lookup › Ingredients › Sodium Monofluorophosphate › 78151-0090-02
KarlnHans Fresh Breath Jasmine Mint Sodium Monofluorophosphate .74 g/100g Paste, Dentifrice — NDC 78151-0090-02 package photo

KarlnHans Fresh Breath Jasmine Mint Sodium Monofluorophosphate .74 g/100g Paste, Dentifrice

by PIGEON CORPORATION · 1 TUBE in 1 CARTON (78151-090-02) / 120 g in 1 TUBE (78151-090-01)
NDC 78151-0090-02
🏷️ FDA NDC (as labeled) 78151-090-02 billing pads the product 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) 78151-090-02
Product NDC 78151-090
11-digit billing NDC 78151009002
RxCUI 1737795
UNII C810JCZ56Q
UPC 8801101890567
Application # M021
SPL Set ID 384863bd-b2cb-a46d-e063-6394a90a3ce2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-23
Route TOPICAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM MONOFLUOROPHOSPHATE
Why two NDCs? The FDA registers this code as 78151-090-02 — 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 → 78151-0090-02. 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, Fluoride
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

LabelerPIGEON CORPORATION
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code78151
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio4 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?

KarlnHans Fresh Breath is a toothpaste containing sodium monofluorophosphate, a fluoride compound. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for toothpaste products rather than as an individually approved application. Sodium monofluorophosphate is commonly used in dentifrices to help strengthen tooth enamel and is typically applied topically by brushing onto teeth. The product also contains jasmine mint flavoring for taste.

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 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesSorbitol, Water, Silica, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Jasmine Flavor, Menthol, Stevioside, Jasmine-Mint Flavor, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract

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
unpa Cha Cha Toothpaste .74 g/100g 73134-0010-02 Lycl 1 tube — — FDA listed —
Unpa Cha Cha Toothpaste .74 g/100g 73242-1111-02 DONG 1 tube — — FDA listed —
Karl and Hans Botanic Double Mint .74 g/100g 78151-0040-02 PIGEON 1 tube — — FDA listed —
Karl and Hans Botanic Jasmine .74 g/100g 78151-0060-02 PIGEON 1 tube — — FDA listed —
KarlnHans Fresh Breath Jasmine Mint .74 g/100gthis 78151-0090-02 PIGEON 1 tube — — FDA listed —
KarlnHans Fresh Breath Double Mint .74 g/100g 78151-0100-02 PIGEON 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 KarlnHans Fresh Breath Jasmine Mint (this brand).

Top reported reactions

Pelvic Fracture2
Abdominal Discomfort1
Abdominal Pain Upper1
Bone Metabolism Disorder1
Burning Sensation1
Cardiac Disorder1
Chest Pain1

Age at onset

Adult1

Reporter sex

9 reports
Male · 78%
Female · 22%

Serious outcomes

Hospitalization3
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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
78151-0090-02 You're viewing this 1 TUBE in 1 CARTON (78151-090-02) / 120 g in 1 TUBE (78151-090-01) 2025-06-23 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 78151-090-02, 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: 78151-0090-02, written without dashes as 78151009002. 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 78151-0090-02, the first segment (78151) is the labeler code FDA assigned to PIGEON CORPORATION; the middle segment (0090) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 PIGEON CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PIGEON CORPORATION 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 48 words ▾

Uses ■ Keep your teeth white and strong. ■ Keeps the oral cavity clean. ■ Refreshes the oral cavity. ■ Prevents cavities and eliminates bad breath. ■ Enhance the aesthetic effect. ■ Prevention of gingivitis, periodontitis (pyorrhoea), periodontal disease, prevention of gum disease. ■ Remove dental plaque (anti-prag).

⏱️ Dosage and Administration 9 words ▾

Directions ■ Brushing the teeth with a suitable amount

⚠️ Warnings 124 words ▾

WARNINGS ■ Fluorine content of this product is 977ppm. ■ In the following cases, immediately stop using this product and consult a doctor or dentist. (1) If you experience any abnormalities such as injury to your gums or the inside of your mouth while using this product. (2) If a child under 6 years old swallows a large amount. ■ Other precautions when using this product.

(1) Be careful not to swallow it and rinse your mouth thoroughly after use. (2) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. ■ Precautions for storage.

(1) Keep out of the reach of children under 6 years of age.

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENT Sodium Monofluorophosphate 0.74%

🧪 Inactive Ingredients 31 words ▾

INACTIVE INGREDIENT Sorbitol, Water, Silica, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Jasmine Flavor, Menthol, Stevioside, Jasmine-Mint Flavor, Titanium Dioxide, Sodium Bicarbonate, Alcloxa, Xylitol, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract

🎯 Purpose 3 words ▾

PURPOSE Caries prevention

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 78151-0060-02 · PIGEON 78151-0100-02 · PIGEON →
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.