botalab HERBAL COMPLETE TOOTH Sodium Fluoride .22 g/100g Paste, Dentifrice
by KMPHARMACEUTICAL CO., LTD. · 1 TUBE in 1 CARTON (50555-201-02) / 150 g in 1 TUBE (50555-201-01)
NDC 50555-0201-02
🏷️ FDA NDC (as labeled)
50555-201-02
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 →
🆔 Identity & classification
FDA NDC (as labeled)
50555-201-02
Product NDC
50555-201
11-digit billing NDC
50555020102
RxCUI
245598
UNII
8ZYQ1474W7
Application #
M021
SPL Set ID
51365ef7-ed94-2650-e063-6394a90ab89e
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-05-01
Route
ORAL
Dosage form
PASTE, DENTIFRICE
Substance
SODIUM FLUORIDE
Why two NDCs?
The FDA registers this code as 50555-201-02 — 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 → 50555-0201-02. 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
LabelerKMPHARMACEUTICAL CO., LTD.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code50555
First marketedMay 2026
Product typeHuman Otc Drug
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
📖 About the active ingredient: Sodium Fluoride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗🧪 What is this product?
Botalab Herbal Complete Tooth is an over-the-counter toothpaste that contains sodium fluoride as its active ingredient. Sodium fluoride is commonly included in dental products to help strengthen tooth enamel and reduce the risk of tooth decay. This product is marketed under the FDA's monograph rules for over-the-counter oral care drugs, meaning it follows an established set of safety and effectiveness standards for the category rather than being individually reviewed by the FDA.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Sodium Fluoride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per g | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Charm Tex FLUORIDE Gel .1 g/100g 42086-0052-01 | Jiangsu | 1000 tubes | — | — | FDA listed | — |
| botalab HERBAL COMPLETE TOOTH .22 g/100gthis 50555-0201-02 | KMPHARMACEUTICAL | 1 tube | — | — | FDA listed | — |
| Freshmint Anticavity Fluoride 2.2 mg/g 51824-0068-01 | New | 7.9 g | — | — | FDA listed | — |
| Maximum Security 2.2 mg/g 53247-0130-01 | Bob | 4.3 g | — | — | FDA listed | — |
| CinnaFresh 2.2 mg/g 53247-0134-01 | Bob | 24 g | — | — | FDA listed | — |
| Maximum Security 2.2 mg/g 53247-0143-01 | Bob | 4.3 g | — | — | Discontinued | — |
| Sodium fluoride .22 g/100g 65517-2000-00 | DUKAL | 17 g | — | — | Discontinued | — |
| DawnMist Gel Fluoride .22 g/100g 65517-2004-00 | Dukal | 78 g | — | — | FDA listed | — |
| DawnMist .22 g/100g 65517-2005-00 | Dukal | 17 g | — | — | FDA listed | — |
| Dawnmist Fluoride .22 g/100g 65517-2017-00 | Dukal | 78 g | — | — | Discontinued | — |
| Sodium Fluoride 220 mg/g 67777-0180-03 | Dynarex | 144 tubes | — | — | FDA listed | — |
| Bubble Fresh Toothpaste, with Fluoride 220 mg/g 67777-0191-03 | Dynarex | 144 tubes | — | — | FDA listed | — |
| Fluoride .22 g/g 68599-9573-01 | McKesson | 24.1 g | — | — | FDA listed | — |
| Botao Kids Strawberry Flavored with Fluoride .122 g/100mL 69435-1405-01 | Peer | 1 tube | — | — | FDA listed | — |
| Gerigentle-Good morning .22 g/100g 69771-0091-38 | Geri-Gentle | 43 g | — | — | FDA listed | — |
| Charm Tex FLUORIDE Gel .1 g/100g 71035-0002-01 | Yangzhou | 1000 tubes | — | — | FDA listed | — |
| ZONSEN Gel Fluoride .22 g/100g 72932-0015-00 | Wuhan | 17 g | — | — | FDA listed | — |
| ZONSEN Toothpaste,white .22 g/100g 72932-0016-00 | Wuhan | 17 g | — | — | FDA listed | — |
| DOCTRUST DOUBLEX Tooth .22 g/100g 73242-1122-02 | DONG | 1 tube | — | — | FDA listed | — |
| DOCTRUST DOUBLEX Tooth .22 g/100g 76670-0010-02 | DOCSMEDI | 1 tube | — | — | FDA listed | — |
| Dr. Jen SuperPaste Nano-Hydroxyapatite .22 g/100mL 84181-0357-05 | Dr | 1 tube | — | — | FDA listed | — |
| Dr. Jen SuperPaste Perio .22 g/100mL 84181-0358-08 | Dr | 1 tube | — | — | FDA listed | — |
| Dr. Jen SuperPaste Ortho .22 g/100mL 84181-0359-09 | Dr | 1 tube | — | — | FDA listed | — |
| Dr. Jen SuperPaste Nano-Hydroxyapatite .22 g/100mL 84181-0735-07 | Dr | 1 tube | — | — | FDA listed | — |
| Willo Bubble Twist 1 mg/mL 84185-0102-08 | Willo | 237 ml | — | — | FDA listed | — |
| Willo Berry Splash Dye Free 1 mg/mL 84185-0202-08 | Willo | 237 ml | — | — | FDA listed | — |
| AMERFRESH FLUORIDE gel .1 g/100g 85162-0001-01 | Yangzhou | 144 tubes | — | — | FDA listed | — |
| Amerfresh Fluoride .1 g/100g 85162-0002-01 | Yangzhou | 144 tubes | — | — | FDA listed | — |
| AdoptaPlatoon .1 g/100mL 85162-0004-01 | Yangzhou | 10 ml | — | — | FDA listed | — |
| Amerfresh Toothpowder .1 g/100g 85162-0007-01 | Yangzhou | 454 g | — | — | FDA listed | — |
| Maximum Security Anticavity Gel fresh mint flavor .1 g/100g 85891-0008-01 | SPARROW | 4.25 g | — | — | Discontinued | — |
| Osstem G Gum Health Care Tooth .22 g/100g 87548-0020-02 | Osstem | 1 tube | — | — | FDA listed | — |
| Cloveden Sensitive Care Tooth .22 g/100g 73242-1113-02 | DONG | 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
🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 botalab HERBAL COMPLETE TOOTH (this brand).
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50555-0201-02 You're viewing this | 1 TUBE in 1 CARTON (50555-201-02) / 150 g in 1 TUBE (50555-201-01) | 2026-05-01 | 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) | — 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 "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 50555-201-02, 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: 50555-0201-02, written without dashes as 50555020102. 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 50555-0201-02, the first segment (50555) is the labeler code FDA assigned to KMPHARMACEUTICAL CO., LTD.; the middle segment (0201) 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 KMPHARMACEUTICAL CO., LTD.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
KMPHARMACEUTICAL CO., LTD. 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 ▾
Use(s) ■ Helps prevent cavities
⏱️ Dosage and Administration ▾
Directions ■ Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. ■ Children 2 to 6 years: Use only a pea-sized amount and supervise brushing to minimize swallowing. ■ Children under 2 years: Ask a dentist or physician.
⚠️ Warnings ▾
Warnings ■ Keep out of reach of children under 6 years of age. ■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. ■ If irritation of the mouth or gums occurs, discontinue use and consult a dentist or physician.
🧪 Active Ingredient ▾
Active ingredient(s) Sodium Fluoride 0.22% (0.10% w/w fluoride ion)
🧪 Inactive Ingredients ▾
Inactive ingredients Sorbitol, Water, Silica, Glycerin, Xylitol, Sodium Cocoyl Glutamate, Flavor, 2,3-Butanediol, Cellulose Gum, Lauramidopropyl Betaine, Stevia Rebaudiana Extract, Sodium Bicarbonate, Menthol, Sodium Chloride, p-Cymene, Butylene Glycol, Aloe Barbadensis Leaf Extract, Maltodextrin, Asiaticoside, Madecassic Acid, Asiatic Acid, Papain, Centella Asiatica Extract, Alcohol, Camellia Sinensis Leaf Extract, Eugenia Caryophyllus (Clove) Bud Oil, Salvia Officinalis (Sage) Extract, Daucus Carota Sativa (Carrot) Root Extract, Sodium Metabisulfite, Commiphora Myrrha Resin Extract, Potassium Sorbate, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Dextrin, Citric Acid, Lactic Acid
🎯 Purpose ▾
Purpose Anticavity
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.