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Sodium Fluoride 5000 Plus 5 mg/g Cream — NDC 69367-0309-51 package photo

Sodium Fluoride 5000 Plus 5 mg/g Cream

by Westminster Pharmaceuticals, LLC · 1 TUBE in 1 CARTON (69367-309-51) / 51 g in 1 TUBE
NDC 69367-0309-51
🏷️ FDA NDC (as labeled) 69367-309-51 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69367-309-51
Product NDC 69367-309
11-digit billing NDC 69367030951
NCPDP billing unit GM — per gram (weight)
RxCUI 392038
UNII 8ZYQ1474W7
SPL Set ID 157b975e-0229-4081-8d7d-b5f933e178e0
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-09
Route DENTAL
Dosage form CREAM
Substance SODIUM FLUORIDE
GPI-14 88402020003721
GPI class Sodium Fluoride 5000 Plus
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 5000 PLUS CRM
FDB brand name Sodium Fluoride 5000 Plus
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 69367-309-51 — 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 → 69367-0309-51. 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.

🏷️ RxNorm drug class

This medicine belongs to the Caries prophylactic agents class.

Drug family (ATC) Caries prophylactic agents, Fluoride
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerWestminster Pharmaceuticals, LLC
Labeler code69367
First marketedMar 2021
Product typeHuman Prescription Drug
Portfolio186 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SODIUM FLUORIDE 5000 PLUS CRM 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 dental cream containing sodium fluoride at a concentration of 5 mg per gram. Sodium fluoride is a fluoride compound typically used in dental products to help strengthen tooth enamel and reduce tooth decay. This product is marketed without an approved FDA application and is available only by prescription.

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.

💊 What it looks like

FlavorSpearmint
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 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 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.

9 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.

💲 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 $0.065 $3.33 / 51 g
Medicaid paysCMS SDUD · 12 mo $0.2117 $10.80 / 51 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.098 $0.064
▼ Down 27% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Denta 5000 Plus 1.1 g/100g 16571-0814-50 Rising 51 g $0.065 — Availability likely —
Sodium Fluoride 5000 Plus 5 mg/gthis 69367-0309-51 Westminster 1 tube $0.065 — Availability likely —
SF 5000 Plus 5 mg/g 60258-0150-01 Cypress 1 tube $0.093 — FDA listed +42%
Sodium Fluoride 5000 ppm Fruit 6 mg/mL 11527-0730-44 Sheffield 1 tube $0.097 — Availability likely +49%
Sodium Fluoride 5000 ppm Spearmint 6 mg/mL 11527-0750-43 Sheffield 1 tube $0.097 — Availability likely +49%
Sodium Fluoride 5000 ppm Dry Mouth 6.1 mg/mL 11527-0755-34 Sheffield 1 tube $0.097 — Availability likely +49%
Sodium Fluoride 5000 PPM 6 mg/mL 69367-0311-01 Westminster 100 ml $0.097 — Availability likely +49%
Sodium Fluoride 5000 PPM 6 mg/mL 69367-0312-01 Westminster 100 ml $0.097 — Availability likely +49%
DentaGel 1.1 g/100g 16571-0815-60 Rising 56 g $0.110 — Availability likely +68%
Sodium Fluoride 1.1% Gel 5 mg/g 69367-0310-56 Westminster 1 tube $0.110 — Availability likely +68%
Sodium Fluoride Gel 5 mg/g 50268-0733-56 AvPAK 1 tube $0.110 — Availability likely +68%
Sodium Fluoride 1.1% 5 mg/g 35573-0435-56 Burel 1 tube $0.110 — Availability likely +68%
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 —
Fluoridex 5 mg/g 59883-0016-04 DEN-MAT 1 tube — — FDA listed —
Fluoridex 5 mg/g 59883-0020-04 DEN-MAT 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 69367-0309-51, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
52.4K
Units reimbursed last 4 qtrs
2.9M
Gross reimbursed last 4 qtrs
$621.5K
Avg / prescription
$11.86
Avg / unit
$0.2117
Latest quarter Q4 2025
12.1KRx
Medicaid pays / g
$0.2117
gross reimbursed
vs
NADAC / g
$0.0653
acquisition cost
=
Spread
+$0.1464
+224% vs cost
What Medicaid paid per g (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 ⓘ
49% FFS 51% MCO
Fee-for-service · 25,744 Rx Managed care · 26,669 Rx
State Medicaid map
Alaska: 561 units · 76.5 per 100k residents AK Maine: 204,663 units · 14,671 per 100k residents ME Washington: 3,060 units · 39.2 per 100k residents WA Idaho: 25,958 units · 1,322 per 100k residents ID Montana: 21,320 units · 1,883 per 100k residents MT North Dakota: 4,539 units · 580 per 100k residents ND Minnesota: 60,037 units · 1,046 per 100k residents MN Wisconsin: 121,334 units · 2,053 per 100k residents WI Michigan: 248,793 units · 2,479 per 100k residents MI New York: 619,125 units · 3,163 per 100k residents NY Vermont: 52,276 units · 8,080 per 100k residents VT New Hampshire: 561 units · 40.0 per 100k residents NH Oregon: 25,194 units · 595 per 100k residents OR Nevada: 9,435 units · 295 per 100k residents NV Wyoming: no data reported WY South Dakota: 18,309 units · 1,992 per 100k residents SD Iowa: 125,558 units · 3,915 per 100k residents IA Illinois: no data reported IL Indiana: 37,637 units · 548 per 100k residents IN Ohio: 117,451 units · 997 per 100k residents OH Pennsylvania: 200,131 units · 1,544 per 100k residents PA New Jersey: 81,039 units · 872 per 100k residents NJ Massachusetts: 109,485 units · 1,564 per 100k residents MA California: 11,730 units · 30.1 per 100k residents CA Utah: 13,056 units · 382 per 100k residents UT Colorado: 16,728 units · 285 per 100k residents CO Nebraska: 29,325 units · 1,483 per 100k residents NE Missouri: 59,368 units · 958 per 100k residents MO Kentucky: 55,886 units · 1,235 per 100k residents KY West Virginia: 23,611 units · 1,334 per 100k residents WV Virginia: 25,186 units · 289 per 100k residents VA Maryland: 63,437 units · 1,026 per 100k residents MD Connecticut: 89,559 units · 2,476 per 100k residents CT Rhode Island: no data reported RI Arizona: 12,998 units · 175 per 100k residents AZ New Mexico: 7,293 units · 345 per 100k residents NM Kansas: 6,783 units · 231 per 100k residents KS Arkansas: 6,987 units · 228 per 100k residents AR Tennessee: 12,597 units · 177 per 100k residents TN North Carolina: 87,861 units · 811 per 100k residents NC South Carolina: 14,127 units · 263 per 100k residents SC Delaware: 10,506 units · 1,019 per 100k residents DE Oklahoma: 21,216 units · 523 per 100k residents OK Louisiana: 17,640 units · 386 per 100k residents LA Mississippi: 27,232 units · 926 per 100k residents MS Alabama: 612 units · 12.0 per 100k residents AL Georgia: 4,896 units · 44.4 per 100k residents GA D.C.: 814 units · 120 per 100k residents DC Hawaii: 9,231 units · 643 per 100k residents HI Texas: 220,465 units · 723 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
12.014,671
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 Maine 14,671 /100k
2 Vermont 8,080 /100k
3 Iowa 3,915 /100k
4 New York 3,163 /100k
5 Michigan 2,479 /100k
6 Connecticut 2,476 /100k
7 Wisconsin 2,053 /100k
8 South Dakota 1,992 /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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Fluoride 5000 Plus — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Fluoride 5000 Plus. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$39K
Claims incl. refills
4.9K
Beneficiaries
3.7K
Spend / beneficiary
$10.61
Spend / claim
$7.93
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 5000 Plus (this brand).

Top reported reactions

Pyrexia173
Nausea162
Weight Increased162
Fatigue161
Vomiting160
Pain158
Nasopharyngitis156

Age at onset

Child16
Adolescent6
Adult75
Elderly78

Reporter sex

0 reports

Serious outcomes

Hospitalization387
Disabling80
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 218 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69367-0309-51 You're viewing this 1 TUBE in 1 CARTON (69367-309-51) / 51 g in 1 TUBE 2021-03-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69367-309-51, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69367-0309-51, written without dashes as 69367030951. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69367-0309-51, the first segment (69367) is the labeler code FDA assigned to Westminster Pharmaceuticals, LLC; the middle segment (0309) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (51) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by 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.

📄 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 📋 Description
🎯 Indications and Usage 96 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 SF 5000 Plus brand of 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 73 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 SF 5000 Plus 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 112 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.

If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

🤒 Adverse Reactions 11 words ▾

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.

🤰 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 SF 5000 Plus 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.

🆘 Overdosage 168 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., 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, 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., 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of SF 5000 Plus 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 49 words ▾

HOW SUPPLIED 1.8 oz. (51 g) net wt. tube Flavor: Spearmint NDC 69367-309-51 You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 (Toll Free). Rx Only

📦 Storage and Handling 36 words ▾

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 (Toll Free). 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 INGREDIENTS: Sodium Fluoride USP 1.1% (w/w) INACTIVE INGREDIENTS: FD&C Blue No. 1, glycerin, hydrated silica, purified water, sodium benzoate, sodium lauryl sulfate, sorbitol, spearmint flavor, titanium dioxide, xanthan gum, dicalcium phosphate, xylitol

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69367-0308-09 · Westminster 69367-0310-56 · 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.