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Sodium Fluoride 5000 ppm Fruit 6 mg/mL Paste, Dentifrice — NDC 11527-0730-44 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Fluoride 5000 ppm Fruit 6 mg/mL Paste, Dentifrice — NDC 11527-730-44 (Billing 11527-0730-44)

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 100 mL in 1 TUBE

This is a package of Sodium Fluoride 5000 ppm Fruit 6 mg/mL Paste, Dentifrice from Sheffield Pharmaceuticals LLC, marketed since Mar 2020 and currently FDA-listed; retail pharmacies pay about $0.0975 per mL (NADAC). It is this product's only package size.

NDC 11527-0730-44
🏷️ FDA NDC (as labeled) 11527-730-44 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11527-730-44
Product NDC 11527-730
11-digit billing NDC 11527073044
NCPDP billing unit ML — per mL (volume)
RxCUI 392038
UNII 8ZYQ1474W7
SPL Set ID a73f72b9-dbcd-4eed-9c20-46a9e8daf859
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-03-26
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE

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

GPI-14 88402020004418
GPI class Sodium Fluoride 5000 PPM
GCN Seq No 060583
GCN 26755
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 5000 PPM PASTE
FDB brand name Sodium Fluoride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060583
  • GCN: 26755
  • GPI-14 (Medi-Span): 88402020004418
  • HICL (First Databank): 001127
  • AHFS class code: 34:04.00.00
  • RxCUI (RxNorm): 392038
Why two NDCs? The FDA registers this code as 11527-730-44 — 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 → 11527-0730-44. 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.

Clinical

Label name SODIUM FLUORIDE 5000 PPM PASTE Ingredient Fluoride (Sodium)
🧪 What is this product?

This is a prescription dental paste containing sodium fluoride at a concentration of 5000 parts per million. Sodium fluoride is typically used in high-strength topical fluoride products to help strengthen tooth enamel and reduce cavity formation. The paste is applied directly to the teeth by a dental professional or as directed. This product is marketed without an approved FDA 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 mLPer package
Retail pharmacies payNADAC · weekly $0.098 $9.75 / 100 ml
Medicaid paysCMS SDUD · 12 mo $0.1474 $14.74 / 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.124 $0.096
▼ Down 3% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11527-0730-44 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 mL in 1 TUBE 2020-03-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Denta 5000 Plus 1.1 g/100g 16571-0814-50 Rising 51 g $0.063 — Availability likely save 35%
Sodium Fluoride 5000 Plus 5 mg/g 69367-0309-51 Westminster 1 tube $0.063 — Availability likely save 35%
SF 5000 Plus 5 mg/g 60258-0150-01 Cypress 1 tube $0.093 — FDA listed save 5%
Sodium Fluoride 5000 ppm Fruit 6 mg/mLthis 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 +11%
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/mL 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

🏛️
2020
On the market since
Mar 2020
📍
2026
Currently FDA-listed
6 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 / pink
FlavorFruit
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSheffield Pharmaceuticals LLC
Labeler code11527
First marketedMar 2020
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.

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Inactive Ingredients 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 97 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 5000 ppm dental cream 1.1% sodium fluoride 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: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 5000 ppm to a toothbrush. Brush thoroughly once daily for at least two minutes, preferably at bedtime. After use, adults expectorate.

For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 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 77 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 can not perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream, which could cause dental fluorosis. Read directions carefully before using.

Keep out of reach of infants and children.

🤒 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 113 words ▾

Pregnancy: 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. 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 5000 ppm 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. 2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

🆘 Overdosage 175 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 emesis, 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 5000 ppm contains 2.5 mg fluoride. A

3.4FLOZ tube (100ml) contains 605 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 28 words ▾

How Supplied

3.4FLOZ (100ml) NET WT. Tube NDC #11527-730-44 FRUIT

3.4FLOZ (100ml) NET WT. Tube NDC #11527-750-43 SPEARMINT STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).

📦 Storage and Handling 8 words ▾

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

🧪 Inactive Ingredients 43 words ▾

Inactive Ingredients: Cellulose Gum, Flavor, Hydrated Silica, Mica, PEG-12, Poloxamer 338, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Tartaric Acid, Titanium Dioxide, Tricalcium Phosphate, Water (Purfied), Xanthum gum. This product also contains flavor, FD&C Blue#1(Spearmint only), FD&C Red No. 33 (Fruit only)

📋 Description 22 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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: 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 have 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: 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. 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 5000 ppm 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.

2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

🍼 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 have 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 33 words ▾

REFERENCES: Accepted Dental Therapeutics, Ed. 40, ADA, Chicago. P. 405-407, 1984. Englander, HR, Keyes et al:JADA 75: 638-644, 1967. Englander, HR, et al:JADA 78: 783-787, 1969. Englander, HR, et al:JADA 83: 354-358, 1971.

📄 Package Label / Principal Display Panel 110 words ▾

PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-750-43 Rx only SODIUM FLUORIDE 5000 ppm SPEARMINT 1.1% Sodium Fluoride Prescription Strength Toothpaste NET WT.

3.4FLOZ. (100ml) Wentworth Spearmint Tube.jpg

PRINCIPAL DISPLAY PANEL - 100ml Carton Wentworth NDC 11527-750-43 Rx only Sodium Fluoride 5000 ppm SPEARMINT 1.1% Sodium Fluoride Prescription Strength toothpaste NET WT 3.4FLOZ (100ml) 544202-SH00147_Carton.jpg

PRINCIPAL DISPLAY PANEL - 100ml Tube Wentworth NDC 11527-730-44 Rx Only Sodium Fluoride 5000 ppm FRUI T 1.1% Sodium Fluoride Prescription Toothpaste

3.4FLOZ (100ml) Wentworth Fruit Tube.jpg

PRINCIPAL DISPLAY PANEL - 100ml Carton Wentworth NDC 11527-730-44 Sodium Fluoride 5000 ppm Rx Only 1.1% Sodium Fluoride Prescription Toothpaste FRUIT

3.4FLOZ (100ml) 544200-SH00146_Fruit_Carton.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
45.3K
Units reimbursed last 4 qtrs
4.6M
Gross reimbursed last 4 qtrs
$672.9K
Avg / prescription
$14.84
Avg / unit
$0.1474
Latest quarter Q1 2026
9.5KRx
Medicaid pays / mL
$0.1474
gross reimbursed
vs
NADAC / mL
$0.0975
acquisition cost
=
Spread
+$0.0499
+51% 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 ⓘ
41% FFS 59% MCO
Fee-for-service · 18,757 Rx Managed care · 26,579 Rx
State Medicaid map
Alaska: 4,700 units · 641 per 100k residents AK Maine: 39,200 units · 2,810 per 100k residents ME Washington: 94,002 units · 1,203 per 100k residents WA Idaho: 42,313 units · 2,154 per 100k residents ID Montana: 19,100 units · 1,687 per 100k residents MT North Dakota: 11,300 units · 1,443 per 100k residents ND Minnesota: 82,900 units · 1,445 per 100k residents MN Wisconsin: 201,565 units · 3,411 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: 26,902 units · 4,158 per 100k residents VT New Hampshire: no data reported NH Oregon: 24,551 units · 580 per 100k residents OR Nevada: 18,600 units · 582 per 100k residents NV Wyoming: no data reported WY South Dakota: 7,160 units · 779 per 100k residents SD Iowa: 48,804 units · 1,522 per 100k residents IA Illinois: 3,600 units · 28.7 per 100k residents IL Indiana: 48,002 units · 700 per 100k residents IN Ohio: no data reported OH Pennsylvania: 235,109 units · 1,814 per 100k residents PA New Jersey: 106,100 units · 1,142 per 100k residents NJ Massachusetts: 489,553 units · 6,993 per 100k residents MA California: 702,206 units · 1,802 per 100k residents CA Utah: 14,300 units · 418 per 100k residents UT Colorado: 62,000 units · 1,055 per 100k residents CO Nebraska: 5,900 units · 298 per 100k residents NE Missouri: 120,500 units · 1,945 per 100k residents MO Kentucky: 167,969 units · 3,711 per 100k residents KY West Virginia: 49,600 units · 2,802 per 100k residents WV Virginia: 29,800 units · 342 per 100k residents VA Maryland: 56,926 units · 921 per 100k residents MD Connecticut: 276,766 units · 7,652 per 100k residents CT Rhode Island: no data reported RI Arizona: 49,800 units · 670 per 100k residents AZ New Mexico: 71,003 units · 3,359 per 100k residents NM Kansas: 21,800 units · 741 per 100k residents KS Arkansas: no data reported AR Tennessee: 70,114 units · 984 per 100k residents TN North Carolina: 350,301 units · 3,233 per 100k residents NC South Carolina: 114,451 units · 2,130 per 100k residents SC Delaware: no data reported DE Oklahoma: 45,500 units · 1,123 per 100k residents OK Louisiana: 86,000 units · 1,880 per 100k residents LA Mississippi: 34,400 units · 1,170 per 100k residents MS Alabama: 17,460 units · 342 per 100k residents AL Georgia: 44,303 units · 402 per 100k residents GA D.C.: 22,300 units · 3,284 per 100k residents DC Hawaii: no data reported HI Texas: 436,473 units · 1,431 per 100k residents TX Florida: 212,761 units · 941 per 100k residents FL
Units reimbursed · per 100k residents
28.77,652
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 7,652 /100k
2 Massachusetts 6,993 /100k
3 Vermont 4,158 /100k
4 Kentucky 3,711 /100k
5 Wisconsin 3,411 /100k
6 New Mexico 3,359 /100k
7 D.C. 3,284 /100k
8 North Carolina 3,233 /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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 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 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.
← 11527-0725-07 · Sheffield 11527-0735-16 · 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.