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TeethWhitening Kit 3 g/100mL; 12 g/100mL; 1 g/100mL Cream, 6 mL — NDC 83778-012-01 (Billing 83778-0012-01)

by Jiangxi Dentalbright Technology Co., Ltd. · 6 mL in 1 BOTTLE

This is a package of 6 mL of TeethWhitening Kit 3 g/100mL; 12 g/100mL; 1 g/100mL Cream from Jiangxi Dentalbright Technology Co., Ltd., marketed since Dec 2024 and currently FDA-listed. It is this product's only package size.

NDC 83778-0012-01
🏷️ FDA NDC (as labeled) 83778-012-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83778-012-01
Product NDC 83778-012
11-digit billing NDC 83778001201
UNII EE90ONI6FF, 5OEJ6FAL6C, 91D9GV0Z28
Application # M022
SPL Set ID 29393313-217a-dc3a-e063-6294a90addb1
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-14
Route TOPICAL
Dosage form CREAM
Substance POTASSIUM CITRATE; PHTHALIMIDOPEROXYCAPROIC ACID; TRIBASIC CALCIUM PHOSPHATE
Why two NDCs? The FDA registers this code as 83778-012-01 — 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 → 83778-0012-01. 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 over-the-counter topical cream marketed under FDA's monograph rules for teeth whitening products. Phthalimidoperoxycaproic acid is an oxidizing agent commonly used in whitening formulas to help bleach tooth discoloration. Potassium citrate and tribasic calcium phosphate are buffering and abrasive ingredients typically included to protect tooth structure and help polish surfaces during the whitening process.

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
83778-0012-01 You're viewing this Main listing 6 mL in 1 BOTTLE 2024-12-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TeethWhitening Kit 3 g/100mL; 12 g/100mL; 1 g/100mLthis 83778-0012-01 Jiangxi 6 ml — — 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

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.

Manufacturer & labeler

LabelerJiangxi Dentalbright Technology Co., Ltd.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code83778
First marketedDec 2024
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.

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 129 words ▾

1. Dry your teeth and rinse mouthpiece before use 2. Looking in the mirror to recor which stage you are with shadeyuide paper.

3. Twist whitening pen until the gel flows. apply the gel evenly on bath upper and lower..teeth. Each time use about 0.5-0.7ml 4.

Put mouthpiece into your mouth and bite it, then press power bltton for 1.5 secondst with blue color, press again to turn red within 5 to start the treatment.(Tips: stad and blue within 5 seconds.)seconds; double press to turn re 5. The led light will turn off automatically after 16 minutes, rinse themouthpiece andmouth with water and compareour teeth with shade guide paperagain to see howmany stages you have improved 6. Don't eat or drink anything exept water in 30 minutes after treatment.

⏱️ Dosage and Administration 138 words ▾

1. Dry your teeth and rinse mouthpiece before use. 2.

Looking in the mirror to record which stage you are with shade guide paper. 3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower teeth.

Each time use about 0.5-0.7ml. 4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds to start the treatment.

(Tips: start with blue color, press again to turn red within 5 seconds; double press to turn red and blue within 5 seconds.) 5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and mouth with water and compare your teeth with shade guide paper again to see how many stages you have improved. 6.

Don't eat or drink anything except water in 30 minutes after treatment.

⚠️ Warnings 18 words ▾

Don't swallow. Avoid applying gel on the gum and lips.Avoid sunlight and keep in dry & cool place

🧪 Active Ingredient 5 words ▾

Phthalimidoperoxycaproic Acid(PAP) Potassium Citrate Hydroxyapatite

🧪 Inactive Ingredients 13 words ▾

Glycerin􀀀Aqua􀀀Polyvinylpyrrolidone(PVP)􀀀Ammonium Acryloyldimethyltaurate/VP Copolymer􀀀Potassium Hydroxide􀀀Mentha Piperita (peppermint) oil 􀀀Mica􀀀Titanium Dioxide􀀀Saccharin Sodium􀀀Piroctone Olamine PRINCIPAL DISPLAY

🎯 Purpose 4 words ▾

Teeth whitening, anti-sensitivity, remineralization

📄 Ask a Doctor Before Use If 6 words ▾

Stop treatment when feel severe pain

📄 When Using This Product 9 words ▾

Don't swallow. Avoidapplying gel on the gum and lips.

📄 Stop Use and Ask a Doctor If 6 words ▾

Stop treatment when feel severe pain

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 1 words ▾

83778-012-01

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
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 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 Jiangxi Dentalbright Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jiangxi Dentalbright Technology 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.
← 83778-0011-01 · Jiangxi 83778-0090-02 · Jiangxi →
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.