Home › NDC Lookup › Ingredients › Sodium Fluoride › 53247-0143-03
Maximum Security Sodium Fluoride 2.2 mg/g Gel, Dentifrice, 24 g — NDC 53247-0143-03 package photo

Maximum Security Sodium Fluoride 2.2 mg/g Gel, Dentifrice, 24 g

by Bob Barker Company Inc. · 24 g in 1 TUBE (53247-143-03)
NDC 53247-0143-03
🏷️ FDA NDC (as labeled) 53247-143-03 billing pads the product segment with a zero
This package
Contains24 g Pack sizes5 compare ↓
Also comes in: 4.3 g 53247-0143-01 17 g 53247-0143-02 43 g 53247-0143-04 130 g 53247-0143-05
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 53247-143-03
Product NDC 53247-143
11-digit billing NDC 53247014303
RxCUI 245598
UNII 8ZYQ1474W7
Application # M021
SPL Set ID f37ea82f-af0a-4319-9063-97529715420b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2008-01-01
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 53247-143-03 — 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 → 53247-0143-03. 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

LabelerBob Barker Company Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code53247
First marketedJan 2008
Product typeHuman Otc Drug
Portfolio11 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 fluoride gel toothpaste containing sodium fluoride. It is a dental monograph product, meaning it follows FDA's standard rules for fluoride dentifrices rather than being individually reviewed. Sodium fluoride is commonly used in toothpastes and gels to help strengthen tooth enamel and reduce cavity formation. The gel form is applied topically to the teeth during regular brushing.

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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 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 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.

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

The official label also statesWater, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Menthol

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: 4.3 g 17 g 43 g 130 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
Charm Tex FLUORIDE Gel .1 g/100g 42086-0052-01 Jiangsu 1000 tubes — — FDA listed —
botalab HERBAL COMPLETE TOOTH .22 g/100g 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/gthis 53247-0143-03 Bob 24 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 —
Frida Fluoride Watermelon 2.2 mg/g 72705-0501-01 Fridababy, 1 tube — — FDA listed —
Frida Fluoride Sweet Mint 2.2 mg/g 72705-0502-01 Fridababy, 1 tube — — FDA listed —
Frida Fluoride Strawberry Toothbrush Set 2.2 mg/g 72705-0504-01 Fridababy, 1 tube — — FDA listed —
Frida Fluoride Bubble Mint 2.2 mg/g 72705-0503-01 Fridababy, 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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 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.

🔬 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 Maximum Security (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization379
Life-threatening84
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 213 0
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 NDCDescription Marketing startStatus
53247-0143-01 4.3 g in 1 PACKET (53247-143-01) 2008-01-01 Inactivated by FDA
53247-0143-02 17 g in 1 TUBE (53247-143-02) 2008-01-01 Inactivated by FDA
53247-0143-03 You're viewing this 24 g in 1 TUBE (53247-143-03) 2008-01-01 Inactivated by FDA
53247-0143-04 43 g in 1 TUBE (53247-143-04) 2008-01-01 Inactivated by FDA
53247-0143-05 130 g in 1 TUBE (53247-143-05) 2008-01-01 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 53247-0143-03?
NDC 53247-0143-03 contains 24 g — 24 g in 1 tube.
What is the difference between NDC 53247-0143-03 and NDC 53247-0143-01?
Both are Maximum Security Sodium Fluoride 2.2 mg/g Gel, Dentifrice — the drug itself is identical. NDC 53247-0143-03 is the 24 g package, while NDC 53247-0143-01 is the 4.3 g package.
What NDC number is used to bill for this package of Maximum Security Sodium Fluoride 2.2 mg/g Gel, Dentifrice?
Bill NDC 53247-0143-03 — the 11-digit billing format is 53247014303. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 53247-143-03, 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: 53247-0143-03, written without dashes as 53247014303. 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 53247-0143-03, the first segment (53247) is the labeler code FDA assigned to Bob Barker Company Inc.; the middle segment (0143) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 4.3 g (53247-0143-01), 17 g (53247-0143-02), 43 g (53247-0143-04). 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?
Bob Barker Company Inc. 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 5 words ▾

Use Helps protect against cavities.

⏱️ Dosage and Administration 60 words ▾

Directions Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years: Ask a dentist or physician.

⚠️ Warnings 32 words ▾

Warnings Keep out of the 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 immediately.

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENT Sodium Fluoride - 0.22% (0.1% W/V fluoride ion)

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Menthol

🎯 Purpose 3 words ▾

PURPOSE Anticavity toothpaste

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53247-0142-01 · Bob 53247-0144-01 · Bob →
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.