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Sodium Fluoride 5000 ppm Enamel Protect Sodium Fluoride1.1%, Potassium Nitrate 5% 57.5 mg/mL; 5.8 mg/mL Gel, Dentifrice

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBE
NDC 11527-0745-34
🏷️ FDA NDC (as labeled) 11527-745-34 billing pads the product segment with a zero
Rx only 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) 11527-745-34
Product NDC 11527-745
11-digit billing NDC 11527074534
NCPDP billing unit ML — per mL (volume)
UNII RU45X2JN0Z, 8ZYQ1474W7
SPL Set ID 83dfdead-4f71-404e-90ae-dbd6849c7cf1
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-08
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
GPI-14 88409902774020
GPI class Sodium Fluoride 5000 Enamel
GCN Seq No 060841
GCN 27029
HICL code 017889
Ingredient (HICL) Sodium Fluoride/Potassium Nit
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D2
Therapeutic class — intermediate (HIC2) Drugs Acting On Teeth
HIC3 code D2A
Therapeutic class — specific (HIC3) Fluoride Preparations
AHFS code 34:04.00.00
AHFS class Nutritional Supplements
FDB label name SOD FLUORIDE ENAM PROT 5000PPM
FDB brand name Sodium Fluoride Enamel Protect
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 11527-745-34 — 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 → 11527-0745-34. 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

LabelerSheffield Pharmaceuticals LLC
Labeler code11527
First marketedJan 2021
Product typeHuman Prescription Drug
Portfolio29 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

Label name SOD FLUORIDE ENAM PROT 5000PPM Ingredient Sodium Fluoride/Potassium Nit
🧪 What is this product?

This is a dental gel containing sodium fluoride and potassium nitrate. Sodium fluoride is typically used in dental products to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is commonly included in dental formulations to help reduce tooth sensitivity. This product is marketed without an FDA-approved 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 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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII VM53EE110J
    A synthetic polymer used as a binder and filler in tablets and capsules. It helps hold ingredients together, improves flow during manufacturing, and can soften the product for easier swallowing.
  • 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 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 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 statescarrageenan, cocamidopropyl betaine, flavor, hydrated silica, PEG-12, poloxamer 407, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum  

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 mLPer package
Retail pharmacies payNADAC · weekly $0.118 $11.76 / 100 ml
Medicaid paysCMS SDUD · 12 mo $0.1546 $15.46 / 100 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Aug 2022 Dec 2025 Aug 2026 $0.128 $0.107
▼ Down 2% over the last 23 months.
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
Sodium Fluoride 5000 ppm Sensitive 5.8 mg/mL; 57.5 mg/mL 11527-0704-42 Sheffield 1 tube $0.118 — Availability likely —
Sodium Fluoride 5000 ppm Enamel Protect 57.5 mg/mL; 5.8 mg/mLthis 11527-0745-34 Sheffield 1 tube $0.118 — Availability likely —
Denta 5000 Plus Sensitive 5.8 mg/mL; 57.5 mg/mL 16571-0823-10 Rising 100 ml $0.118 — Availability likely —
Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mL 69367-0318-01 Westminster 1 tube $0.118 — Availability likely —
PreviDent 5000 Enamel Protect 5.8 mg/mL; 57.5 mg/mL 00126-0022-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Sensitive 5.8 mg/mL; 57.5 mg/mL 00126-0070-61 Colgate 100 ml — — FDA listed —
Acclean Anti-Cavity Sensitivity Relief 5 g/100g; 1.1 g/100g 00404-0174-04 Henry 1 tube — — FDA listed —
Ionite H 1.1 mg/100g; 5 mg/100g 53045-0280-04 Dharma 122 g — — FDA listed —
Ionite H 1.1 mg/100g; 5 mg/100g 53045-0281-04 Dharma 122 g — — FDA listed —
FluoriMax 5000 Sensitive 1.1 g/100g; 5 g/100g 57511-0503-01 Elevate 96 g — — FDA listed —
Fluoridex 5 mg/g; 50 mg/g 59883-0030-04 DENT-MAT 1 tube — — FDA listed —
Fluoridex 50 mg/g; 5 mg/g 59883-0031-04 DENT-MAT 1 tube — — FDA listed —
Pro-Sys 5 g/100g; 1.1 g/100g 66975-0778-01 Benco 113 g — — FDA listed —
Pro-Sys 1.1 g/100g; 5 g/100g 66975-0779-01 Benco 113 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 11527-0745-34, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7.2K
Units reimbursed last 4 qtrs
705.1K
Gross reimbursed last 4 qtrs
$109K
Avg / prescription
$15.19
Avg / unit
$0.1546
Latest quarter Q4 2025
1.7KRx
Medicaid pays / mL
$0.1546
gross reimbursed
vs
NADAC / mL
$0.1176
acquisition cost
=
Spread
+$0.0370
+31% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
35% FFS 65% MCO
Fee-for-service · 2,518 Rx Managed care · 4,661 Rx
State Medicaid map
Alaska: 3,200 units · 437 per 100k residents AK Maine: 1,500 units · 108 per 100k residents ME Washington: 23,363 units · 299 per 100k residents WA Idaho: 17,900 units · 911 per 100k residents ID Montana: 10,000 units · 883 per 100k residents MT North Dakota: no data reported ND Minnesota: 16,900 units · 295 per 100k residents MN Wisconsin: 58,302 units · 986 per 100k residents WI Michigan: 64,500 units · 643 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 1,200 units · 131 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 18,200 units · 265 per 100k residents IN Ohio: no data reported OH Pennsylvania: 1,100 units · 8.5 per 100k residents PA New Jersey: 35,551 units · 383 per 100k residents NJ Massachusetts: 59,400 units · 848 per 100k residents MA California: 6,000 units · 15.4 per 100k residents CA Utah: no data reported UT Colorado: 10,502 units · 179 per 100k residents CO Nebraska: no data reported NE Missouri: 48,600 units · 784 per 100k residents MO Kentucky: 45,826 units · 1,013 per 100k residents KY West Virginia: 4,900 units · 277 per 100k residents WV Virginia: 2,900 units · 33.3 per 100k residents VA Maryland: no data reported MD Connecticut: 50,000 units · 1,382 per 100k residents CT Rhode Island: no data reported RI Arizona: 3,900 units · 52.5 per 100k residents AZ New Mexico: 8,800 units · 416 per 100k residents NM Kansas: 1,400 units · 47.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 9,800 units · 138 per 100k residents TN North Carolina: 53,600 units · 495 per 100k residents NC South Carolina: 11,000 units · 205 per 100k residents SC Delaware: no data reported DE Oklahoma: 10,700 units · 264 per 100k residents OK Louisiana: 35,100 units · 767 per 100k residents LA Mississippi: 13,800 units · 469 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 47,451 units · 156 per 100k residents TX Florida: 29,700 units · 131 per 100k residents FL
Units reimbursed · per 100k residents
8.51,382
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 1,382 /100k
2 Kentucky 1,013 /100k
3 Wisconsin 986 /100k
4 Idaho 911 /100k
5 Montana 883 /100k
6 Massachusetts 848 /100k
7 Missouri 784 /100k
8 Louisiana 767 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Sodium Fluoride1.1%, Potassium Nitrate 5% — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury1
Acute Myocardial Infarction1
Angina Unstable1
Atrial Fibrillation1
Atrial Flutter1
Cerebral Ischaemia1
Decreased Appetite1

Age at onset

Adult1

Reporter sex

2 reports
Male · 50%
Female · 50%
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1 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
11527-0745-34 You're viewing this 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBE 2021-01-08 Active

🧭 About this NDC listing & data coverage

Finished prescription 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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.
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 11527-745-34, 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: 11527-0745-34, written without dashes as 11527074534. 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 11527-0745-34, the first segment (11527) is the labeler code FDA assigned to Sheffield Pharmaceuticals LLC; the middle segment (0745) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (34) 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 Sheffield Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sheffield Pharmaceuticals LLC 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Inactive Ingredients 📋 Description
🎯 Indications and Usage 137 words ▾

INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adults patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.

1-4 Sodium Fluoride 5000 ppm Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be in used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.

(See WARNINGS for exception.)

⏱️ Dosage and Administration 89 words ▾

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and children 12 years of age and older: Apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by dentist or physician.

Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

⚠️ Warnings 69 words ▾

WARNINGS: Not for systemic treatment- DO NOT SWALLOW. Keep out of the reach of infants and children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

🤒 Adverse Reactions 28 words ▾

ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 127 words ▾

Pregnancy: Teratogenic Effects Pregnancy Category B . It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen.

Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects.

Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

🧒 Pediatric Use 26 words ▾

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

🧓 Geriatric Use 27 words ▾

Geriatric Use: No studies of Sodium Fluoride 5000 ppm Enamel Protect have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.

🆘 Overdosage 181 words ▾

OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomitting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours.

If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomitting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomitting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of Sodium Fluoride 5000 ppm Enamel Protect contains approximately 2.5 mg fluoride. A

3.4FL OZ (100 mL) tube contains approximately 575 mg fluoride.

🧬 Clinical Pharmacology 32 words ▾

CLINICAL PHARMACOLOGY: Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

📦 How Supplied / Storage and Handling 19 words ▾

HOW SUPPLIED: Mint

3.4FL OZ (100 mL) tube NDC 11527-745-34 STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C).

📦 Storage and Handling 8 words ▾

STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C).

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients: carrageenan, cocamidopropyl betaine, flavor, hydrated silica, PEG-12, poloxamer 407, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

📋 Description 14 words ▾

DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11527-0735-16 · Sheffield 11527-0750-43 · Sheffield →
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.