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BIS II Tooth Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate .04 g/100g; .1 g/100g; .04 g/100g; .04 g/100g Paste, Dentifrice, 135 g — NDC 69653-0202-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BIS II Tooth Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate .04 g/100g; .1 g/100g; .04 g/100g; .04 g/100g Paste, Dentifrice, 135 g — NDC 69653-202-01 (Billing 69653-0202-01)

by Jewoo Medical CO.,LTD · 135 g in 1 TUBE

This is a package of 135 g of BIS II Tooth Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate .04 g/100g; .1 g/100g; .04 g/100g; .04 g/100g Paste, Dentifrice from Jewoo Medical CO.,LTD, marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 69653-0202-01
🏷️ FDA NDC (as labeled) 69653-202-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 69653-202-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69653 labeler · 202 product · 01 package
Package marketed since
Jan 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6965320201 9
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69653-202-01
Product NDC 69653-202
11-digit billing NDC 69653020201
UNII O7TSZ97GEP, H0G9379FGK, 9E8X80D2L0, 18B8O9DQA2
SPL Set ID 49f942e6-ceef-5505-e063-6394a90a113f
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance DIBASIC CALCIUM PHOSPHATE DIHYDRATE; CALCIUM CARBONATE; .ALPHA.-TOCOPHEROL ACETATE; ALCLOXA
Why two NDCs? The FDA registers this code as 69653-202-01 — 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 → 69653-0202-01. 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?

This is an unapproved over-the-counter toothpaste containing calcium carbonate and dibasic calcium phosphate, which are abrasive and polishing agents typically used in dentifrices to help clean and remove debris from tooth surfaces. The paste also contains alpha-tocopherol acetate (a form of vitamin E) and alcloxa, ingredients commonly found in oral care products. 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69653-0202-01 You're viewing this Main listing 135 g in 1 TUBE 2026-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
BIS II Tooth .04 g/100g; .1 g/100g; .04 g/100g; .04 g/100g 69653-0201-01 Jewoo 100 g — — FDA listed —
BIS II Tooth .04 g/100g; .1 g/100g; .04 g/100g; .04 g/100gthis 69653-0202-01 Jewoo 135 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

🏛️
2026
On the market since
Jan 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.

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 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.

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

The official label also statesGlycerin D-Sorbitol Solution Silica Carboxymethylcellulose Sodium Sodium Cocoyl Glycinate Mica Chitosan Xylitol Steviol Glycoside L-Menthol Glycyrrhiza Extract Sophora Flavescens Extract Scutellaria Baicalensis Root Extract Salvia Officinalis (Sage) Extract Calendula Officinalis Flower Extract Gentiana Lutea Root Extract Rosmarinus Officinalis (Rosemary) Extract Aloe Barbadensis Leaf Extract Citrus Paradisi (Grapefruit) Seed Extract Lavandula Angustifolia (Lavender) Extract Propolis Extract Eucalyptus Globulus Leaf Oil Chamaecyparis Obtusa Oil Pistacia Lentiscus (Mastic) Gum Anethole fravor Silver Activated Carbon Hydroxyapatite 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.

Manufacturer & labeler

LabelerJewoo Medical CO.,LTD
Labeler code69653
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from Jewoo Medical CO.,LTD labeler code 69653

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a tentist or physician. Do not shallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

⏱️ Dosage and Administration 4 words ▾

for external use only

⚠️ Warnings 30 words ▾

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.

🧪 Active Ingredient 12 words ▾

Precipitated Calcium Carbonate Tocopherol Acetate Dibasic Calcium Phosphate Hydrate Aluminium Chlorohydroxy Allantoinate

🧪 Inactive Ingredients 73 words ▾

Glycerin D-Sorbitol Solution Silica Carboxymethylcellulose Sodium Sodium Cocoyl Glycinate Mica Chitosan Xylitol Steviol Glycoside L-Menthol Glycyrrhiza Extract Sophora Flavescens Extract Scutellaria Baicalensis Root Extract Salvia Officinalis (Sage) Extract Calendula Officinalis Flower Extract Gentiana Lutea Root Extract Rosmarinus Officinalis (Rosemary) Extract Aloe Barbadensis Leaf Extract Citrus Paradisi (Grapefruit) Seed Extract Lavandula Angustifolia (Lavender) Extract Propolis Extract Eucalyptus Globulus Leaf Oil Chamaecyparis Obtusa Oil Pistacia Lentiscus (Mastic) Gum Anethole fravor Silver Activated Carbon Hydroxyapatite Water

🎯 Purpose 9 words ▾

Aids in the prevention of cavities, plaque, and gingivitis

📄 Keep Out of Reach of Children 7 words ▾

keep out of reach of the children

📄 Package Label / Principal Display Panel 2 words ▾

1 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Jewoo Medical CO.,LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jewoo Medical 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.
← 69653-0201-01 · Jewoo 69654-0579-30 · Aytu →
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.