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Bubble Gum Flavor For Kids 25g 50g .25 g/100g Ointment, 25 g — NDC 85215-0001-01 package photo

Bubble Gum Flavor For Kids 25g 50g .25 g/100g Ointment, 25 g

by WORLD DENTISTS ASSOCIATION AMERICA LIMITED · 25 g in 1 TUBE (85215-001-01)
NDC 85215-0001-01
🏷️ FDA NDC (as labeled) 85215-001-01 billing pads the product segment with a zero
This package
Contains25 g Pack sizes2 compare ↓
Also comes in: 50 g 85215-0001-02
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) 85215-001-01
Product NDC 85215-001
11-digit billing NDC 85215000101
UNII 8ZYQ1474W7
UPC 0612461261076, 0612461002440
Application # M022
SPL Set ID 354c1eda-ec5b-a8c7-e063-6294a90a871d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-17
Route DENTAL
Dosage form OINTMENT
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 85215-001-01 — 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 → 85215-0001-01. 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.

🏭 Manufacturer & labeler

LabelerWORLD DENTISTS ASSOCIATION AMERICA LIMITED
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code85215
First marketedMay 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?

This is an over-the-counter dental ointment for kids that contains sodium fluoride, a mineral commonly used to help strengthen tooth enamel and reduce cavity formation. The product comes in a bubblegum flavor and is applied directly to the teeth and gums. As an OTC monograph drug, it is marketed under FDA's established rules for fluoride dental products rather than as an individually reviewed application. Sodium fluoride is typically used in dental care products to support oral health in children.

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 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.
  • UNII 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • 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 77HY82S0LG
    A synthetic polymer used as a binder and lubricant in tablet formulations. It helps hold ingredients together and reduces friction during manufacturing and packaging.
  • UNII ABS794681C
    A plant extract from schisandra berries used in traditional medicine. It may be included as a natural flavoring agent or for its potential antioxidant properties in the formulation.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive ingredients Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

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.
Try another pack size: 50 g
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
Bubble Gum Flavor For Kids 25g 50g .25 g/100gthis 85215-0001-01 WORLD 25 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

🏛️
2025
On the market since
May 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
85215-0001-01 You're viewing this 25 g in 1 TUBE (85215-001-01) 2025-05-17 Active
85215-0001-02 50 g in 1 TUBE (85215-001-02) 2025-05-17 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 85215-0001-01?
NDC 85215-0001-01 contains 25 g — 25 g in 1 tube.
What is the difference between NDC 85215-0001-01 and NDC 85215-0001-02?
Both are Bubble Gum Flavor For Kids 25g 50g .25 g/100g Ointment — the drug itself is identical. NDC 85215-0001-01 is the 25 g package, while NDC 85215-0001-02 is the 50 g package.
What NDC number is used to bill for this package of Bubble Gum Flavor For Kids 25g 50g .25 g/100g Ointment?
Bill NDC 85215-0001-01 — the 11-digit billing format is 85215000101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 85215-001-01, 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: 85215-0001-01, written without dashes as 85215000101. 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 85215-0001-01, the first segment (85215) is the labeler code FDA assigned to WORLD DENTISTS ASSOCIATION AMERICA LIMITED; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 WORLD DENTISTS ASSOCIATION AMERICA LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 g (85215-0001-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
WORLD DENTISTS ASSOCIATION AMERICA LIMITED 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 6 words ▾

Use Use helps protect against cavities

⏱️ Dosage and Administration 58 words ▾

Directions Adults and children 2 years of age 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 child's brushing and rinsing (to minimize swallowing) Children under 2years Ask a dentist or physician

⚠️ Warnings 32 words ▾

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.

📦 Storage and Handling 30 words ▾

Other information Store in a cool place, below 86° F, away from heat Do not use if quality seal is broken or missing Do not use after the expiration date

🧪 Active Ingredient 5 words ▾

Active Ingredient(s) Sodium Fluoride 0.25%

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients Inactive ingredients Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

🎯 Purpose 2 words ▾

Purpose Anticavity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85214-0025-05 · SOUTH 85215-0002-02 · WORLD →
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.