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Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mL Gel — NDC 69367-318-01 (Billing 69367-0318-01)

by Westminster Pharmaceuticals, LLC · 1 TUBE in 1 CARTON / 100 mL in 1 TUBE

This is a package of Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mL Gel from Westminster Pharmaceuticals, LLC, marketed since Jun 2022 and currently FDA-listed; retail pharmacies pay about $0.1161 per mL (NADAC). It is this product's only package size.

NDC 69367-0318-01
🏷️ FDA NDC (as labeled) 69367-318-01 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 69367-318-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69367 labeler · 318 product · 01 package
Package marketed since
Jun 15, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6936731801 3
Medicaid fills, this package
1,486 prescriptions in the last four reported quarters
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69367-318-01
Product NDC 69367-318
11-digit billing NDC 69367031801
NCPDP billing unit ML — per mL (volume)
RxCUI 637365
UNII 8ZYQ1474W7, RU45X2JN0Z
SPL Set ID 7a051d80-879d-4995-96ef-77b60dad26b7
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-15
Route DENTAL
Dosage form GEL
Substance SODIUM FLUORIDE; POTASSIUM NITRATE

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

GPI-14 88409902774020
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 SODIUM FLUORIDE-POTASSIUM NITR
FDB brand name Sodium Fluoride-Potassium Nitr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060841
  • GCN: 27029
  • GPI-14 (Medi-Span): 88409902774020
  • HICL (First Databank): 017889
  • AHFS class code: 34:04.00.00
  • RxCUI (RxNorm): 637365
Why two NDCs? The FDA registers this code as 69367-318-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69367-0318-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name SODIUM FLUORIDE-POTASSIUM NITR Ingredient Sodium Fluoride/Potassium Nit
🧪 What is this product?

This is a dental gel containing sodium fluoride and potassium nitrate. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. Potassium nitrate is typically included in products designed to address tooth sensitivity by reducing pain signals from the tooth surface. This product is an unapproved drug marketed without a current 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 $0.116 $11.61 / 100 ml
Medicaid paysCMS SDUD · 12 mo $0.1806 $18.06 / 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 2025 Mar 2026 Jun 2026 Sep 2026 $0.119 $0.107
▲ Up 8% over the last 10 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
69367-0318-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 mL in 1 TUBE 2022-06-15 — Active

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 $0.116 — Availability likely —
Sodium Fluoride 5000 ppm Enamel Protect 57.5 mg/mL; 5.8 mg/mL 11527-0745-34 Sheffield 1 tube $0.116 — Availability likely —
Denta 5000 Plus Sensitive 5.8 mg/mL; 57.5 mg/mL 16571-0823-10 Rising 100 ml $0.116 — Availability likely —
Sodium Fluoride and Potassium Nitrate 5.8 mg/mL; 57.5 mg/mLthis 69367-0318-01 Westminster 1 tube $0.116 — 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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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 Green
FlavorPeppermint
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

LabelerWestminster Pharmaceuticals, LLC
Labeler code69367
First marketedJun 2022
Product typeHuman Prescription Drug
Portfolio186 products on file

More NDCs from Westminster Pharmaceuticals, LLC labeler code 69367

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 🧓 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 128 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, acid, sweets or contact in adult 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 1.1% and Potassium Nitrate 5% Sensitive in a squeeze-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 used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis.

(See WARNINGS for exception.)

⏱️ Dosage and Administration 91 words ▾

DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: Adults and children 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice daily, (morning and evening) or as recommended by a 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 68 words ▾

WARNINGS Not for systemic treatment - DO NOT SWALLOW. Keep out of the reach of 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 Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 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 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 29 words ▾

Geriatric Use No studies of Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.

🆘 Overdosage 182 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 1.1% and Potassium Nitrate 5% Sensitive 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 21 words ▾

How Supplied

3.4FL OZ (100mL) net wt. tube NDC 69367-318-01 Mild Mint 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)

📋 Description 52 words ▾

DESCRIPTION Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate. Active Ingredients Sodium Fluoride 1.1% (w/w) Potassium Nitrate 5% Inactive Ingredients D&C Yellow No.10, Dicalcium Phosphate, FD&C Blue No.1, Glycerin, Hydrated Silica, Mint Flavor, Purified Water, Sodium Benzoate, Sodium Luaryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Xanthum Gum.

⚠️ Precautions ~2 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 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 No studies of Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.

🍼 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 36 words ▾

REFERENCES American Dental Association, Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407(1984). H.R. Englander et al., JADA, 75, 638-644 (1967). H.R. Englander et al., JADA, 78, 783-787 (1969). H.R. Englander et al., JADA, 82, 354-358 (1971).

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton MILD MINT NDC 69367-318-01 Rx Only Sodium Fluoride 1.1% and Potassium Nitrate 5% Prescription Strength Toothpaste for Sensitive Teeth Sensitive

3.4FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

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
1.5K
Units reimbursed last 4 qtrs
147K
Gross reimbursed last 4 qtrs
$26.6K
Avg / prescription
$17.87
Avg / unit
$0.1806
Latest quarter Q1 2026
516Rx
Medicaid pays / mL
$0.1806
gross reimbursed
vs
NADAC / mL
$0.1161
acquisition cost
=
Spread
+$0.0645
+56% 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 ⓘ
55% FFS 45% MCO
Fee-for-service · 822 Rx Managed care · 664 Rx
State Medicaid map
Alaska: 3,800 units · 518 per 100k residents AK Maine: no data reported ME Washington: 18,000 units · 230 per 100k residents WA Idaho: 2,700 units · 137 per 100k residents ID Montana: 7,200 units · 636 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,100 units · 18.6 per 100k residents WI Michigan: 9,751 units · 97.2 per 100k residents MI New York: 50,405 units · 258 per 100k residents NY Vermont: 8,700 units · 1,345 per 100k residents VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 6,400 units · 200 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 6,200 units · 52.6 per 100k residents OH Pennsylvania: 4,800 units · 37.0 per 100k residents PA New Jersey: 8,951 units · 96.4 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 1,900 units · 32.3 per 100k residents CO Nebraska: no data reported NE Missouri: 5,700 units · 92.0 per 100k residents MO Kentucky: 3,300 units · 72.9 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,800 units · 16.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 6,301 units · 138 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
16.61,345
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 Vermont 1,345 /100k
2 Montana 636 /100k
3 Alaska 518 /100k
4 New York 258 /100k
5 Washington 230 /100k
6 Iowa 200 /100k
7 Louisiana 138 /100k
8 Idaho 137 /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 Fluoride and Potassium Nitrate — the ingredient across all brands.

Top reported reactions

Fatigue80
Nausea71
Diarrhoea68
Fall53
Headache52
Pain50
Rash43

Age at onset

Child1
Adolescent2
Adult84
Elderly77

Reporter sex

1,035 reports
Male · 37%
Female · 63%

Serious outcomes

Hospitalization266
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 129 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.

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) — 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 Westminster Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Westminster 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.
← 69367-0312-01 · Westminster 69367-0323-04 · Westminster →
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.