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CVS Enamel Guard Fluoride .15 g/100g; 5 g/100g Paste, Dentifrice — NDC 51316-0128-89 package photo

CVS Enamel Guard Fluoride .15 g/100g; 5 g/100g Paste, Dentifrice

by CVS Pharmacy · 1 TUBE in 1 CARTON (51316-128-89) / 113 g in 1 TUBE
NDC 51316-0128-89
🏷️ FDA NDC (as labeled) 51316-128-89 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 51316-128-89
Product NDC 51316-128
11-digit billing NDC 51316012889
RxCUI 1038929
UNII 8ZYQ1474W7, RU45X2JN0Z
UPC 0050428058053
Application # M022
SPL Set ID d9dfa515-426b-9059-e053-2a95a90a3885
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-01-20
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Why two NDCs? The FDA registers this code as 51316-128-89 — 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 → 51316-0128-89. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerCVS Pharmacy
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedJan 2011
Product typeHuman Otc Drug
Portfolio550 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

📗 Our plain-language guide HelloPharmacist
  • Fluoride toothpaste works to protect your teeth from cavities. When you brush with it regularly, it helps shield your teeth from the acids that break down enamel (the hard outer la...
  • What is fluoride toothpaste actually doing for my teeth?
  • Both 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity and Equate Anticavity Oral Rinse are meant to be used twice a day, after you've already brushed your te...
  • How often should I use a fluoride mouth rinse?
📖 Read our full Fluoride guide →

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

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

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 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.

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

The official label also stateswater, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sensodyne Extra Whitening 50 mg/g; 1.11 mg/g 00135-0525-03 Haleon 1 tube — — FDA listed —
Aquafresh Sensitive Maximum Strength 50 mg/g; 1.1 mg/g 00135-0605-01 Haleon 1 tube — — FDA listed —
Sensodyne Extra Whitening Cool Mint 50 mg/g; 1.15 mg/g 00135-0643-01 Haleon 1 tube — — FDA listed —
Walgreens Sensitive Extra Whitening 5 g/100g; .15 g/100g 00363-1588-09 Walgreens 1 tube — — FDA listed —
TheraBreath .24 g/100g; 5 g/100g 10237-0273-04 Church 1 tube — — FDA listed —
Sensitive Teeth and Gums 2.43 mg/g; 50 mg/g 10237-0669-45 Church 1 tube — — FDA listed —
Target Sensitive Whitening TP 5 g/100g; .24 g/100g 11673-0237-79 Target 1 tube — — FDA listed —
Rite Aid Extra Whitening .15 g/100g; 5 g/100g 11822-5020-09 Rite 1 tube — — FDA listed —
Signature Care Enamel Guard Sensitive Gentle Whitening .15 g/100g; 5 g/100g 21130-0350-19 Safeway 1 tube — — FDA listed —
Signature Care Sensitive Maximum Strength .15 g/100g; 5 g/100g 21130-0351-19 Safeway 1 tube — — FDA listed —
Kroger Extra Whitening .15 g/100g; 5 g/100g 30142-0149-99 Kroger 1 tube — — FDA listed —
Kroger Enamel Protection Sensitive Gentle Whitening 5 g/100g; .15 g/100g 30142-0362-99 Kroger 1 tube — — FDA listed —
Colgate Sensitive plus Whitening 50 mg/g; 1.1 mg/g 35000-0023-34 Colgate-Palmolive 2 tubes — — FDA listed —
Colgate Sensitive Complete Protection 50 mg/g; 1.1 mg/g 35000-0024-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sensitive Prevent and Repair 50 mg/g; 1.1 mg/g 35000-0128-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sensitive Enamel Health 50 mg/g; 1.1 mg/g 35000-0130-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sensitive Whitening 50 mg/g; 1.1 mg/g 35000-0131-34 Colgate-Palmolive 2 tubes — — FDA listed —
Colgate Sensitive Complete Protection 50 mg/g; 1.1 mg/g 35000-0132-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Stain Fighter Sens Relief 1.5 mg/g; 50 mg/g 35000-0998-60 Colgate-Palmolive 1 tube — — FDA listed —
Topco Associates LLC Maximum Strength .15 g/100g; 5 g/100g 36800-0364-10 Topco 1 tube — — FDA listed —
TopCare Sensitive Extra Whitening .15 g/100g; 5 g/100g 36800-0451-59 TOPCO 1 tube — — FDA listed —
Top Care Enamel Guard .15 g/100g; 5 g/100g 36800-0681-19 TOPCO 1 tube — — FDA listed —
HEB Sensitive Extra Whitening Twin .15 g/100g; 5 g/100g 37808-0237-10 HEB 2 tubes — — FDA listed —
HEB Extra Whitening .15 g/100g; 5 g/100g 37808-0681-19 HEB 1 tube — — Discontinued —
HEB Extra Whitening .15 g/100g; 5 g/100g 37808-0961-19 HEB 1 tube — — FDA listed —
Meijer Enamel Guard .15 g/100g; 5 g/100g 41250-0514-09 Meijer 1 tube — — FDA listed —
Care One Maximum Strength .15 g/100g; 5 g/100g 41520-0415-09 American 1 tube — — FDA listed —
Care One Maximum Strength .15 g/100g; 5 g/100g 41520-0582-19 American 1 tube — — FDA listed —
equate Sensitive 5 g/100g; .15 g/100g 49035-0257-29 Wal-Mart 1 tube — — FDA listed —
Opalescence Whitening Sensitivity Relief 1.1 mg/g; 50 mg/g 51206-0315-01 Ultradent 1 tube — — FDA listed —
CVS Enamel Guard .15 g/100g; 5 g/100gthis 51316-0128-89 CVS 1 tube — — FDA listed —
Freshmint Sensitive 2.4 mg/g; 50 mg/g 51824-0053-02 New 1 tube — — FDA listed —
DG health Sensitive Maximum Strength .24 g/100g; 5 g/100g 55910-0360-39 Dolgencorp, 1 tube — — FDA listed —
Rexall Sensitive Extra Whitening 5 g/100g; .24 g/100g 55910-0817-01 Old 1 tube — — FDA listed —
Rexall Sensitive Freshmint 5 g/100g; .24 g/100g 55910-0819-01 Old 1 tube — — FDA listed —
Sensitive Extra Whitening .15 g/100g; 5 g/100g 56062-0413-33 Publix 1 tube — — FDA listed —
CVS Extra Whitening .15 g/100g; 5 g/100g 59779-0122-29 CVS 1 tube — — Discontinued —
MIPaste One 5 g/100g; .24 g/100g 61596-0400-10 GC 1 tube — — FDA listed —
Natural White Sensitive Enamel Guard Alpine Mint .15 g/100g; 5 g/100g 62721-0002-01 Lornamead 1 tube — — FDA listed —
Lornamead Natural White .15 g/100g; 5 g/100g 62721-0470-07 Lornamead 1 tube — — FDA listed —
Made by Dentists Enamel Rebuilding Professional 50 mg/g; 1.5 mg/g 62776-0003-01 Fulijaya 1 tube — — FDA listed —
Made by Dentists Sensitive and Whitening Professional 50 mg/g; 1.5 mg/g 62776-0004-01 Fulijaya 1 tube — — FDA listed —
Quality Choice Natural White .15 g/100g; 5 g/100g 63868-0172-23 CHAIN 1 tube — — Discontinued —
Colgate Optic White Relief 50 mg/g; 1.5 mg/g 65954-0834-59 Mission 1 tube — — FDA listed —
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT 5 g/100g; .24 g/100g 70108-0254-01 Ashtel 1 tube — — FDA listed —
dentalux SENSITIVE ANTI-CAVITY FLUORIDE 5 g/100g; .24 g/100g 71141-0187-10 Lidl 1 tube — — FDA listed —
Trader Joes 2.4 mg/g; 50 mg/g 71270-0110-06 TRADER 170 g — — FDA listed —
Wintergreen Peppermint 50 mg/g; 1.5 mg/g 72164-0005-00 Twice 96 g — — FDA listed —
Made By Dentists, Inc. Rebuilding 5 g/100g; .24 g/100g 75065-0019-06 Made 1 tube — — Discontinued —
Made by Dentists Enamel Rebuilding Fresh Mint 50 mg/g; 1.5 mg/g 75065-0028-06 MADE 1 tube — — FDA listed —
Made by Dentists Sensitive and Whitening Fresh Mint 50 mg/g; 1.5 mg/g 75065-0029-06 MADE 1 tube — — FDA listed —
Freshen Up 5 g/100g; 24 mg/100g 77782-0002-13 MKJ 113 g — — FDA listed —
Sensitive Mint Tooth-paste 50 mg/g; 2.43 mg/g 79481-0009-01 Meijer, 1 tube — — FDA listed —
meijer Sensitive EXTRA WHITENING 5 g/100g; .24 g/100g 79481-0038-01 Meijer, 1 tube — — FDA listed —
meijer Sensitive FRESH MINT 5 g/100g; .24 g/100g 79481-0039-01 Meijer, 1 tube — — FDA listed —
Ollie Fresh Mint 2.4 mg/g; 50 mg/g 87493-0000-01 Brio 1 tube — — FDA listed —
Topco Associates LLC Maximum Strength .15 g/100g; 5 g/100g 36800-0481-49 Topco 1 tube — — FDA listed —
Pronamel Repair Whitening .15 g/100g; 5 g/100g 11822-6310-01 Rite 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

🏛️
2011
On the market since
Jan 2011
📍
2026
Currently FDA-listed
15 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.

🔬 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 CVS Enamel Guard (this brand).

Top reported reactions

Toxicity To Various Agents16
Headache15
Completed Suicide14
Nausea13
Asthenia12
Fatigue11
Insomnia11

Age at onset

Infant2
Adult4
Elderly2

Reporter sex

220 reports
Male · 38%
Female · 61%
Unknown · 0%

Serious outcomes

Hospitalization49
Death26
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 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
51316-0128-89 You're viewing this 1 TUBE in 1 CARTON (51316-128-89) / 113 g in 1 TUBE 2012-11-30 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51316-128-89, 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: 51316-0128-89, written without dashes as 51316012889. 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 51316-0128-89, the first segment (51316) is the labeler code FDA assigned to CVS Pharmacy; the middle segment (0128) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (89) 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 CVS Pharmacy. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Pharmacy 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 46 words ▾

Directions Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

⏱️ Dosage and Administration 54 words ▾

adults and children 12 years of age and older: a pply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush thoroughly for at least one minute twice a day, or as recommended by a dentist or doctor. Children under 12 years of age: Consult a dentist or a doctor.

⚠️ Warnings 70 words ▾

When using this product, if irritation accurs discontinue use. Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a dentist if if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use.

🧪 Active Ingredient 14 words ▾

Active ingredients / Purpose Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0..24% (0.15% w/v fluoride ion).........................Anticavity

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

🎯 Purpose 23 words ▾

Uses builds increasing protection against painful sensitivty of teeth to cold, heat, acids, sweets or contact aids in the prevention of dental cavities

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51316-0124-48 · CVS 51316-0129-01 · CVS →
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.