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Sodium Flouride Sodium Fluoride 5 mg/mL Paste, Dentifrice, 1 tube — NDC 42291-0741-51 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Flouride Sodium Fluoride 5 mg/mL Paste, Dentifrice, 1 tube — NDC 42291-741-51 (Billing 42291-0741-51)

by AvKARE · 1 TUBE in 1 CARTON / 53.2 mL in 1 TUBE

This is a package of 1 tube of Sodium Flouride Sodium Fluoride 5 mg/mL Paste, Dentifrice from AvKARE, marketed since Sep 2019 and currently FDA-listed. It is this product's only package size.

NDC 42291-0741-51
🏷️ FDA NDC (as labeled) 42291-741-51 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Past resolved recalls for this product (1)
Class II · Aug 11, 2023 · Terminated — Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste (AVKARE LLC) · FDA recall D-1146-2023

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42291-741-51
Product NDC 42291-741
11-digit billing NDC 42291074151
NCPDP billing unit GM — per gram (weight)
UNII 8ZYQ1474W7
UPC 0342291741515
SPL Set ID 92fef2e0-f9f2-8b0f-e053-2995a90a096a
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-20
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 88402020003721
GPI class Sodium Fluoride
GCN Seq No 024145
GCN 02820
HICL code 001127
Ingredient (HICL) Fluoride (Sodium)
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 SODIUM FLUORIDE 1.1% CREAM
FDB brand name Sodium Fluoride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 024145
  • GCN: 02820
  • GPI-14 (Medi-Span): 88402020003721
  • HICL (First Databank): 001127
  • AHFS class code: 34:04.00.00
Why two NDCs? The FDA registers this code as 42291-741-51 — 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 → 42291-0741-51. 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

Label name SODIUM FLUORIDE 1.1% CREAM Ingredient Fluoride (Sodium)
📖 About the active ingredient: Sodium Fluoride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is a prescription fluoride paste applied directly to the teeth. Sodium fluoride is a mineral compound commonly used in dental products to strengthen tooth enamel and help prevent tooth decay. The paste form allows the fluoride to remain in contact with the tooth surface during 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
42291-0741-51 You're viewing this Main listing 1 TUBE in 1 CARTON / 53.2 mL in 1 TUBE 2019-09-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Denta 5000 Plus 1.1 g/100g 16571-0814-50 Rising 51 g $0.063 — Availability likely —
Sodium Fluoride 5000 Plus 5 mg/g 69367-0309-51 Westminster 1 tube $0.063 — Availability likely —
SF 5000 Plus 5 mg/g 60258-0150-01 Cypress 1 tube $0.093 — FDA listed —
Sodium Fluoride 5000 ppm Fruit 6 mg/mL 11527-0730-44 Sheffield 1 tube $0.097 — Availability likely —
Sodium Fluoride 5000 ppm Spearmint 6 mg/mL 11527-0750-43 Sheffield 1 tube $0.097 — Availability likely —
Sodium Fluoride 5000 ppm Dry Mouth 6.1 mg/mL 11527-0755-34 Sheffield 1 tube $0.097 — Availability likely —
Sodium Fluoride 5000 PPM 6 mg/mL 69367-0311-01 Westminster 100 ml $0.097 — Availability likely —
Sodium Fluoride 5000 PPM 6 mg/mL 69367-0312-01 Westminster 100 ml $0.097 — Availability likely —
DentaGel 1.1 g/100g 16571-0815-60 Rising 56 g $0.108 — Availability likely —
PreviDent 5000 Dry Mouth 6.1 mg/mL 00126-0016-61 Colgate 100 ml — — FDA listed —
PreviDent 5000 Booster Plus Fruitastic 6 mg/mL 00126-0072-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Booster Plus Spearmint 6 mg/mL 00126-0074-92 Colgate 100 ml — — FDA listed —
PreviDent Fresh Mint 5 mg/g 00126-0088-02 Colgate 1 tube — — FDA listed —
PreviDent 5000 Plus Fruitastic 11 mg/g 00126-0286-66 Colgate 1 tube — — FDA listed —
PreviDent 5000 Plus Spearmint 11 mg/g 00126-0287-66 Colgate 1 tube — — FDA listed —
PreviDent Very Berry 5 mg/g 00126-0288-02 Colgate 1 tube — — FDA listed —
PreviDent OrthoDefense 6 mg/mL 00126-0289-92 Colgate 100 ml — — FDA listed —
PreviDent 5000 Kids 6 mg/mL 00126-0311-92 Colgate 100 ml — — FDA listed —
Acclean Anti-Cavity 1.1 g/100g 00404-0173-04 Henry 1 tube — — FDA listed —
Sodium Flouride 5 mg/mLthis 42291-0741-51 AvKARE 1 tube — — FDA listed —
Clinpro 5000 5 mg/g 48878-3120-04 Solventum 1 tube — — FDA listed —
Clinpro 5000 5 mg/g 48878-3130-04 Solventum 1 tube — — FDA listed —
Clinpro 5000 5 mg/g 48878-3140-04 Solventum 1 tube — — FDA listed —
Just Right 5000 1.1 g/100g 57511-0001-01 Elevate 97 g — — FDA listed —
Just Right 5000 1.1 g/100g 57511-0002-01 Elevate 97 g — — FDA listed —
Just Right 5000 1.1 g/100g 57511-0003-01 Elevate 97 g — — FDA listed —
Allday 5000 1.1 g/100g 57511-0005-01 Elevate 2 tubes — — FDA listed —
FluoriMax 5000 1.1 g/100g 57511-0504-01 Elevate 96 g — — FDA listed —
PRO Gel 5000 Mint 5000 ug/g 61578-0215-01 DENTAL 68 g — — FDA listed —
PRO Gel 5000 Citrus 5000 ug/g 61578-0216-01 DENTAL 68 g — — FDA listed —
Neutramaxx 5000 Plus Turbo 1.1 g/112g 63783-0500-04 Massco 112 g — — FDA listed —
Neutramaxx 5000 Tcp 1.1 g/112g 63783-0501-04 Massco 112 g — — FDA listed —
Neutra Maxx 5000 1.428 g/120g 63783-0504-06 Massco 120 g — — FDA listed —
Prosys .11 g/100g 66975-0782-01 Benco 113 g — — FDA listed —
Super Mint Prescription 1.1 g/100g 83729-0102-10 SuperMouth, 1 tube — — FDA listed —
Super Chocolate Prescription 1.1 g/100g 83729-0103-10 SuperMouth, 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color blue
FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 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 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 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 J7I2T6IV1N
    Spearmint is a plant-derived flavoring agent added to medicines to improve taste. It helps mask bitter or unpleasant flavors, making the medication easier to take.
  • 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.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

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

LabelerAvKARE
Labeler code42291
First marketedSep 2019
Product typeHuman Prescription Drug
Portfolio384 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 90 words ▾

INDICATIONS AND USAGE A dental caries preventive; for once daily self-applied topical use. 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 1.1% in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.

May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

⏱️ Dosage and Administration 74 words ▾

DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 1.1% toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime.

2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes.

Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

⚠️ Warnings 93 words ▾

WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream which could cause dental fluorosis. Read directions carefully before using.

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

🤒 Adverse Reactions 46 words ▾

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. You should call your doctor, or dental professional for medical advise about serious adverse events. To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 (Toll Free).

🤰 Pregnancy 126 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 70 words ▾

Pediatric Use The use of Sodium Fluoride 1.1% toothpaste in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11- 14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

🧓 Geriatric Use 128 words ▾

Geriatric Use Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 174 words ▾

OVERDOSAGE Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, 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 vomiting, 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 vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of Sodium Fluoride 1.1% toothpaste contains 2.5 mg fluoride. A 1.8 oz. tube contains 255 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 31 words ▾

HOW SUPPLIED 1.8 oz. (51 g) net wt. tube NDC# 42291-741-51 STORAGE Store at controlled room temperature 20° - 25°C (68°-77°F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN Rx Only

📦 Storage and Handling 20 words ▾

STORAGE Store at controlled room temperature 20° - 25°C (68°-77°F). KEEP THIS PRODUCT OUT OF REACH OF CHILDREN Rx Only

📋 Description 55 words ▾

DESCRIPTION Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Active Ingredient Sodium fluoride 1.1% (w/w). Inactive Ingredients Dicalcium Phosphate, FD&C Blue No. 1, Flavor, Glycerin, Hydrated Silica, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Spearmint Flavor, Titanium Dioxide, Xanthan Gum, Xylitol

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight.

Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting.

Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water.

Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. 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. Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman.

Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use The use of Sodium Fluoride 1.1% toothpaste in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11- 14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

Please refer to the CONTRAINDICATIONS and WARNINGS sections. Geriatric Use Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decrease… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 82 words ▾

Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight).

No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight.

Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed.

In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated.

Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

📚 References 90 words ▾

REFERENCES 1. American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407 (1984).

2. H.R. Englander et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 75, 638-644 (1967).

3. H.R. Englander, et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA 78, 783-787 (1969).

4. H.R. Englander HR et al., Incremental Rates of Dental Caries After Repeated Topical Sodium Fluoride Applications in Children With Lifelong Consumption of Fluoridated Water, JADA, 82, 354-358, (1971).

📄 Package Label / Principal Display Panel 9 words ▾

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton 1

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

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 ✓ 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 AvKARE. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AvKARE 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.
← 42291-0740-30 · AvKARE 42291-0758-01 · AvKARE →
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.