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DOCTRUST ONE S Tooth Sodium fluoride, Dental type silica, Potassium nirate .31 g/100g; 18.5 g/100g; 5 g/100g Paste, Dentifrice — NDC 76670-0016-02 package photo

DOCTRUST ONE S Tooth Sodium fluoride, Dental type silica, Potassium nirate .31 g/100g; 18.5 g/100g; 5 g/100g Paste, Dentifrice

by DOCSMEDI Co., Ltd. · 1 TUBE in 1 CARTON (76670-0016-2) / 100 g in 1 TUBE (76670-0016-1)
NDC 76670-0016-02
🏷️ FDA NDC (as labeled) 76670-0016-2 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 76670-0016-2
Product NDC 76670-0016
11-digit billing NDC 76670001602
UNII 8ZYQ1474W7, ETJ7Z6XBU4, RU45X2JN0Z
UPC 8809805370347
SPL Set ID 3382776a-a10e-1823-e063-6394a90a6f91
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE; SILICON DIOXIDE; POTASSIUM NITRATE
Why two NDCs? The FDA registers this code as 76670-0016-2 — a 5-4-1 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 package segment → 76670-0016-02. 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.

🏭 Manufacturer & labeler

LabelerDOCSMEDI Co., Ltd.
Labeler code76670
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio7 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?

Doctrust One S is a toothpaste containing sodium fluoride, potassium nitrate, and dental-type silica. Sodium fluoride is commonly used in dentifrices to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is typically included in toothpastes to address tooth sensitivity by blocking sensation transmission in the tooth nerve. Dental silica functions as a mild abrasive to help remove surface stains during brushing. This product is marketed without an approved FDA 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.

🧪 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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.

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

The official label also statesSodium carboxymethyl cellulose, D-sorbitol solution, Concentrated glycerin, Xylitol, Enzymatically modified stevia, Hydroxyapatite, Taraxacum officinale extract, Turmeric root extract, Green tea extract, Calendula extract, Eucalyptus extract, Salvia officinalis (sage) extract, Aloe extract(09), L-menthol, Herb mint flavor, Cooling flavor, Menthol pulegium oil, Sodium lauroyl sarcosinate, Sodium cocoyl glutamate, Purified water

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
DOCTRUST ONE S Tooth .31 g/100g; 18.5 g/100g; 5 g/100gthis 76670-0016-02 DOCSMEDI 1 tube — — FDA listed —
DOCTRUST ONE S Tooth .31 g/100g; 18.5 g/100g; 5 g/100g 73242-1124-02 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

🏛️
2025
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76670-0016-02 You're viewing this 1 TUBE in 1 CARTON (76670-0016-2) / 100 g in 1 TUBE (76670-0016-1) 2025-04-01 Active

🧭 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 FDA registers it as 76670-0016-2, 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: 76670-0016-02, written without dashes as 76670001602. 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 76670-0016-02, the first segment (76670) is the labeler code FDA assigned to DOCSMEDI Co., Ltd.; the middle segment (0016) 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 DOCSMEDI Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DOCSMEDI 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 16 words ▾

Uses ■ Builds increasing protection against painful sensitivity ■ Aids in the prevention of dental cavities.

⏱️ Dosage and Administration 84 words ▾

Directions ■ Adults and children 12 years of age and older: • Apply at least 1-inch strip of the product onto a soft bristle toothbrush • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. ■ Children under 12 years of age: Consult a dentist or doctor.

⚠️ Warnings 73 words ▾

WARNINGS ■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if ■ For children under 6 years of age, use small amounts of toothpaste. under the supervision of a guardian to avoid sucking or swallowing. ■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. ■ Keep out of the reach of children under 6 years of age.

🧪 Active Ingredient 18 words ▾

ACTIVE INGREDIENT Sodium fluoride 0.3152% (Total Fluoride Content 1,426 ppm Approx.) Dental type silica 18.50% Potassium nirate 5.00%

🧪 Inactive Ingredients 50 words ▾

INACTIVE INGREDIENTS Sodium carboxymethyl cellulose, D-sorbitol solution, Concentrated glycerin, Xylitol, Enzymatically modified stevia, Hydroxyapatite, Taraxacum officinale extract, Turmeric root extract, Green tea extract, Calendula extract, Eucalyptus extract, Salvia officinalis (sage) extract, Aloe extract(09), L-menthol, Herb mint flavor, Cooling flavor, Menthol pulegium oil, Sodium lauroyl sarcosinate, Sodium cocoyl glutamate, Purified water

🎯 Purpose 6 words ▾

PURPOSE Anti plaque, Anticaries, Anticavity, Antihypersensitivity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76670-0015-02 · DOCSMEDI 76670-0017-02 · DOCSMEDI →
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.