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Whitening Tooth Polish Sodium Fluoride .26244 g/108g Paste, 108 g — NDC 54473-0301-04 package photo

Whitening Tooth Polish Sodium Fluoride .26244 g/108g Paste, 108 g

by Melaleuca, Inc. · 108 g in 1 TUBE (54473-301-04)
NDC 54473-0301-04
🏷️ FDA NDC (as labeled) 54473-301-04 billing pads the product segment with a zero
OTC 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) 54473-301-04
Product NDC 54473-301
11-digit billing NDC 54473030104
RxCUI 891775
UNII 8ZYQ1474W7
Application # M021
SPL Set ID 6893405a-a2c4-068e-e053-2a91aa0ae5b1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-04-01
Route TOPICAL
Dosage form PASTE
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 54473-301-04 — 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 → 54473-0301-04. 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

LabelerMelaleuca, Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code54473
First marketedApr 2010
Product typeHuman Otc Drug
Portfolio22 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

📖 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 topical toothpaste containing sodium fluoride, marketed as an over-the-counter monograph product under FDA's established rules for oral care. Sodium fluoride is typically used in dental products to help strengthen tooth enamel and reduce the risk of cavities. The product is formulated as a paste applied directly to the teeth during brushing. It is intended for routine oral hygiene and cavity prevention.

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

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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • 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 H74221J5J4
    Myrrh oil is a fragrant resin extracted from myrrh tree bark. It is used in medicines as a flavoring agent and to add aroma or taste to the product.
  • UNII A236A06Y32
    Papain is an enzyme derived from papaya fruit. In medicines, it works as a proteolytic agent to help break down proteins and improve the dissolving or absorption of active ingredients in the formulation.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII B9W4019H5G
    Tetrapotassium pyrophosphate is a mineral salt used as a buffering agent and emulsifier in medicines. It helps stabilize formulations and maintain proper pH levels.
  • 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 O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • 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 VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesInactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol

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
Dr Tichenors With Extra Whitening and Tartar Control 2.43 mg/g 11291-0243-02 Dr. 1 tube — — FDA listed —
Tanners Tasty Cha Cha Chocolate 2.43 mg/g 11527-0044-58 Sheffield 119 g — — FDA listed —
Tanners Tasty Ooh La La Orange 2.43 mg/g 11527-0045-42 Sheffield 119 g — — FDA listed —
Tanners Tasty Vanilla Bling 2.43 mg/g 11527-0180-58 Sheffield 119 g — — FDA listed —
Target Kids Watermelon Mint .15 g/100g 11673-0308-01 Target 1 tube — — FDA listed —
Spry Dentifrice 2.43 mg/g 27017-0142-01 Xlear 1 g — — FDA listed —
The Natural Dentist Groovy Grape .243 g/100g 34362-0233-02 Caldwell 141 g — — FDA listed —
Peppermint Twist .243 g/100g 34362-0237-02 Caldwell 1 tube — — FDA listed —
Crest Cavity Protection Regular 1.5 mg/g 37000-0005-01 The 2.5 g — — Discontinued —
Crest Tartar Protection 1.5 mg/g 37000-0008-02 The 1 tube — — Discontinued —
Crest Tartar Protection Fresh Mint Gel 1.5 mg/g 37000-0009-06 The 1 tube — — Discontinued —
Crest Cavity Protection Cool Mint Gel 1.5 mg/g 37000-0025-08 The 1 tube — — FDA listed —
Crest Baking Soda and Peroxide Whitening with Tartar Protection 1.6 mg/g 37000-0044-02 The 2 tubes — — FDA listed —
Kids Crest Cavity Protection Sparkle Fun 1.5 mg/g 37000-0049-01 The 1 tube — — FDA listed —
Crest Strawberry 1.5 mg/g 37000-0171-42 The 119 g — — FDA listed —
Crest Bubblegum 1.5 mg/g 37000-0174-42 The 119 g — — FDA listed —
Crest 3D White Whitening Therapy Deep Clean Charcoal 1.5 mg/g 37000-0215-24 Procter 1 tube — — FDA listed —
Crest Complete plus Whitening plus Scope Outlast 1.5 mg/g 37000-0445-40 The 1 tube — — FDA listed —
Crest Complete Multi Benefit Whitening plus Scope Outlast 1.5 mg/g 37000-0504-05 The 1 cello — — Discontinued —
Kids Crest Strawberry Rush 1.5 mg/g 37000-0511-42 The 1 tube — — FDA listed —
Crest Complete Multi-Benefit Plus Scope 1.1 mg/g 37000-0822-04 The 130 g — — FDA listed —
Kids Crest Bubblegum Flavor 1.5 mg/g 37000-0839-01 The 119 g — — FDA listed —
Crest Fresh and White 1.5 mg/g 37000-0868-02 The 1 tube — — Discontinued —
Crest 3D White Brilliance 1.6 mg/g 37000-0873-04 The 1 tube — — Discontinued —
Crest 3D White Arctic Fresh 1.5 mg/g 37000-0875-02 The 2 tubes — — FDA listed —
Crest 3D White Radiant Mint 1.5 mg/g 37000-0876-01 The 1 tube — — FDA listed —
Crest 3D White Brilliance Blast 1.6 mg/g 37000-0916-35 The 1 tube — — FDA listed —
Burts Bees Extra White Zen Peppermint 1.3 mg/g 37000-0925-47 Procter 1 tube — — FDA listed —
Crest 3D White Stain Shield 1.6 mg/g 37000-0938-02 The 2 tubes — — Discontinued —
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions 1.5 mg/g 37000-0943-06 The 1 tube — — Discontinued —
Crest 3D White Charcoal 1.5 mg/g 37000-0945-02 Procter 1 cello — — FDA listed —
Crest complete plus Whitening Deep Clean 1.4 mg/g 37000-0946-02 The 2 tubes — — FDA listed —
Burts Bees Charcoal Peppermint 1.3 mg/g 37000-0965-47 Procter 1 tube — — FDA listed —
Native Whitening 1.4 mg/g 37000-0973-41 Procter 1 tube — — FDA listed —
Burts Bees Kids Strawberry Splash 1.3 mg/g 37000-0980-42 Procter 119 g — — Discontinued —
Crest Complete Plus Scope Outlast 1.5 mg/g 37000-0983-04 The 130 g — — FDA listed —
Crest Complete Plus 3 in 1 1.5 mg/g 37000-0984-04 The 130 g — — FDA listed —
Crest 3D White Brilliance Charcoal 1.5 mg/g 37000-0989-39 Procter 1 tube — — FDA listed —
Crest Premium Plus Scope Dual Blast Active Foam 1.5 mg/g 37000-0990-03 The 1 cello — — Discontinued —
Crest Premium Plus Scope Outlast Active Foam 1.5 mg/g 37000-0991-03 The 1 cello — — FDA listed —
Crest Premium Plus Advanced Whitening Active Foam 1.5 mg/g 37000-0993-72 The 1 tube — — FDA listed —
Crest Premium Plus Deep Clean Active Foam 1.5 mg/g 37000-0994-52 The 1 tube — — FDA listed —
HEB Gleaming White Arctic Mint .15 g/100g 37808-0320-59 HEB 1 tube — — FDA listed —
HEB Gleaming White Fresh Mint .15 g/100g 37808-0330-59 HEB 1 tube — — FDA listed —
MediChoice Premium Anticavity Fluoride 2.43 mg/g 39892-0603-02 O&M 24 g — — FDA listed —
EUTHYMOL Extraordinary Pink Whitening 1.6 mg/g 43136-0501-06 Tai 1 tube — — FDA listed —
EUTHYMOL Extraordinary Pink Whitening 1.6 mg/g 43136-0502-20 Tai 1 tube — — FDA listed —
POP Hint Of Mint 1.4 mg/g 43136-0511-20 Tai 1 tube — — FDA listed —
POP Feeling Peachy 1.4 mg/g 43136-0512-20 TAI 1 tube — — FDA listed —
POP Gel Pumpin Strawberry 1.3 mg/g 43136-0521-60 Tai 1 tube — — FDA listed —
POP Gel Whatzzup Watermelon 1.3 mg/g 43136-0522-60 Tai 1 tube — — FDA listed —
HIMALAYA PINK SALT Intensive Whitening Spearmint 1.5 mg/g 43136-0591-20 Tai 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste 1.5 mg/g 43136-0592-10 Tai 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint 1.5 mg/g 43136-0593-11 Tai 1 tube — — FDA listed —
PERIOE POP Advanced Whitening Prebiotic Cool Mint 1.6 mg/g 43136-0602-01 Tai 1 tube — — FDA listed —
PERIOE POP Complete Protection Prebiotic Mint Blast 1.4 mg/g 43136-0603-01 Tai 1 tube — — FDA listed —
AVON Whitening Essentials 10X Charcoal Black Clean Mint 1.6 mg/g 43136-0801-01 Tai 1 tube — — FDA listed —
PERIOE Whitening Essentials Fresh Aloe Green Mint 1.6 mg/g 43136-0802-01 Tai 1 tube — — FDA listed —
PERIOE Whitening Essentials 10X Charcoal Black Clean Mint 1.6 mg/g 43136-0803-02 Tai 1 tube — — FDA listed —
PERIOE Microbiome Whitening Cool Mint 1.6 mg/g 43136-0810-01 Tai 1 tube — — FDA listed —
PERIOE Microbiome Total Care Strong Mint 1.4 mg/g 43136-0820-01 Tai 1 tube — — FDA listed —
AVON Whitening Essentials Original Cool Mint 1.6 mg/g 43136-0901-01 Tai 1 tube — — FDA listed —
AVON Whitening Essentials Blanc Charcoal Fresh Mint 1.6 mg/g 43136-0902-01 Tai 1 tube — — FDA listed —
AVON Whitening Essentials Blanc Charcoal Fresh Mint 1.6 mg/g 43136-0903-01 Tai 1 tube — — FDA listed —
Crest Cavity Protection Cool Mint 1.5 mg/g 50090-6233-00 A-S 24 tubes — — FDA listed —
Toms Luminous White Fluoride Clean Mint cavity protection / whitening .00243 g/g 51009-0218-40 Tom's 1 tube — — FDA listed —
Ocean Friends Anticavity Fluoride Watermelon Flavor .243 g/100g 51316-0162-01 CVS 130 g — — FDA listed —
Ocean Friends Anticavity Fluoride Bubblegum Flavor .243 g/100g 51316-0163-01 CVS 130 g — — FDA listed —
Freshmint Premium Anticavity 2.43 mg/g 51824-0029-02 New 144 tubes — — FDA listed —
Freshmint Premium Anticavity 2.43 mg/g 51824-0034-01 New 130 g — — FDA listed —
Freshmint Premium Anticavity Gel 2.43 mg/g 51824-0046-02 New 144 tubes — — FDA listed —
Universal Charcoal With Aloe Vera Anti-Cavity Fluoride .15 g/100g 52000-0110-01 Universal 122 g — — FDA listed —
PERIOE KAKAO KIDS Strawberry 1.3 mg/g 53208-0461-60 LG 1 bottle — — FDA listed —
EUTHYMOL Extraordinary Pink Whitening 1.6 mg/g 53208-0561-06 LG 1 tube — — FDA listed —
EUTHYMOL Extraordinary Pink Whitening 1.6 mg/g 53208-0562-20 LG 1 tube — — FDA listed —
Euthymol Whitening 1.5 mg/g 53208-0566-65 LG 1 tube — — FDA listed —
Euthymol Whitening Set 53208-0568-00 LG 1 kit — — FDA listed —
Euthymol Whitening Travel 53208-0569-00 LG 1 kit — — FDA listed —
POP Hint Of Mint 1.4 mg/g 53208-0571-20 LG 1 tube — — FDA listed —
POP Feeling Peachy 1.4 mg/g 53208-0572-20 LG 1 tube — — FDA listed —
EUTHYMOL WHITENING GIFT SET (40gX3) 53208-0573-00 LG 1 kit — — FDA listed —
Euthymol Whitening Special Gift Set 53208-0574-00 LG 1 kit — — FDA listed —
POP Gel Pumpin Strawberry 1.3 mg/g 53208-0581-60 LG 1 tube — — FDA listed —
POP Gel Whatzzup Watermelon 1.3 mg/g 53208-0582-60 LG 1 tube — — FDA listed —
HIMALAYA PINK SALT Intensive Whitening Spearmint 1.5 mg/g 53208-0591-20 LG 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste 1.5 mg/g 53208-0592-10 LG 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint 1.5 mg/g 53208-0593-11 LG 1 tube — — FDA listed —
Whitening Tooth Polish .26244 g/108gthis 54473-0301-04 Melaleuca, 108 g — — FDA listed —
Crest Cavity Protection Regular 1.5 mg/g 58933-0005-04 Procter 1 tube — — Discontinued —
Crest Tartar Protection 1.5 mg/g 58933-0008-02 Procter 1 tube — — Discontinued —
Crest Complete Multi-Benefit Whitening plus Scope 1.5 mg/g 58933-0020-03 Procter 1 tube — — FDA listed —
Crest Kids SparkleFun Bubblegum 1.5 mg/g 58933-0023-42 Procter 119 g — — FDA listed —
Crest Strawberry 1.5 mg/g 58933-0045-42 Procter 119 g — — FDA listed —
Crest Bubblegum 1.5 mg/g 58933-0046-42 Procter 119 g — — FDA listed —
Crest Bubblegum 1.5 mg/g 58933-0047-42 Procter 119 g — — FDA listed —
Crest Strawberry 1.5 mg/g 58933-0048-42 Procter 119 g — — FDA listed —
Kids Crest Cavity Protection Sparkle Fun 1.5 mg/g 58933-0049-01 Procter 24 g — — FDA listed —
Crest Strawberry 1.5 mg/g 58933-0171-42 Procter 119 g — — FDA listed —
Crest Fresh and White 1.5 mg/g 58933-0868-02 Procter 1 tube — — Discontinued —
Crest 3D White Stain Eraser 1.5 mg/g 58933-0879-23 Procter 1 tube — — FDA listed —
Crest 3D White Fresh Mint 1.5 mg/g 58933-0881-23 Procter 1 tube — — FDA listed —
Crest 3D White Stain Eraser Icy Clean Mint 1.5 mg/g 58933-0932-35 Procter 1 tube — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0723-01 9055-7588 120 g — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0724-01 9055-7588 120 g — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0725-01 9055-7588 120 g — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0730-01 9055-7588 120 g — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0731-01 9055-7588 120 g — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0732-01 9055-7588 120 g — — FDA listed —
Bio Spectra Attitude .243 g/100g 61649-0734-01 9055-7588 120 g — — FDA listed —
Natural White Radiant White .15 g/100g 62721-0473-09 Lornamead 1 tube — — FDA listed —
Toothpaste, plus Toothbrush 66715-7011-05 Lil' 1 kit — — FDA listed —
Rembrandt Intense Stain 24.3 mg/g 66923-0373-02 Ranir 1 tube — — FDA listed —
Sodium Fluoride 2.43 mg/g 67239-0226-00 Safco 24 g — — FDA listed —
Sodium Fluoride 2.43 mg/g 67239-0227-00 Safco 72 tubes — — FDA listed —
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope 1.5 mg/g 67751-0095-01 Navajo 1 tube — — FDA listed —
Crest Cavity Protection Regular 1.5 mg/g 67751-0124-01 Navajo 1 tube — — FDA listed —
Crest 3D White Brilliance Pro Enamel Protect 1.6 mg/g 69423-0750-03 The 1 tube — — FDA listed —
Crest 3D White Advanced Express White 1.5 mg/g 69423-0762-38 The 1 tube — — FDA listed —
Crest 3D White Advanced Charcoal 1.5 mg/g 69423-0767-27 The 1 tube — — FDA listed —
Crest 3D White Advanced Glamorous White 1.6 mg/g 69423-0768-38 The 1 tube — — FDA listed —
Crest 3D White Advanced Luminous Mint 1.6 mg/g 69423-0769-37 The 1 tube — — FDA listed —
Crest 3D White Advanced Radiant Mint 1.5 mg/g 69423-0770-22 The 2 tubes — — Discontinued —
Crest 3D White Advanced Stain Shield 1.5 mg/g 69423-0772-38 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Icy Clean Mint 1.5 mg/g 69423-0773-31 The 1 tube — — FDA listed —
Crest 3D White Vibrant Mint 1.5 mg/g 69423-0774-23 The 1 tube — — FDA listed —
Crest 3D White Brilliance Luminous Purple 1.6 mg/g 69423-0787-35 The 1 tube — — FDA listed —
Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection 1.6 mg/g 69423-0814-11 The 2 tubes — — FDA listed —
Crest Cavity Protection Cool Mint Gel 1.5 mg/g 69423-0815-11 The 2 tubes — — FDA listed —
Crest Plus Cavity Protection Cool Mint Gel 1.5 mg/g 69423-0816-57 The 1 tube — — FDA listed —
Crest Plus Tartar Protection 1.5 mg/g 69423-0817-24 The 1 tube — — FDA listed —
Crest plus Tartar Protection Whitening 1.5 mg/g 69423-0818-57 The 1 tube — — FDA listed —
Burts Bees Kids Strawberry Splash 1.3 mg/g 69423-0819-47 Procter 133 g — — FDA listed —
Crest Plus Active Fresh plus Whitening Scope 1.5 mg/g 69423-0823-55 The 1 tube — — FDA listed —
Burts Bees Complete Multi-Care 1.3 mg/g 69423-0835-14 Procter 1 cello — — FDA listed —
Crest 3D White Advanced Deep Clean 1.5 mg/g 69423-0836-23 Procter 2 tubes — — FDA listed —
Crest Plus Cinnamon Expressions plus Whitening 1.5 mg/g 69423-0840-23 The 1 tube — — FDA listed —
Crest Plus Whitening Deep Clean 1.5 mg/g 69423-0842-02 The 2 tubes — — FDA listed —
Crest 3D White Ultra Vivid Mint 1.5 mg/g 69423-0850-52 The 1 tube — — FDA listed —
Crest 4in1 1.5 mg/g 69423-0852-24 The 1 tube — — FDA listed —
Crest 3D White Advanced Whitening 1.6 mg/g 69423-0853-05 The 1 cello — — Discontinued —
Crest 3D White Stain Eraser Fresh Mint 1.5 mg/g 69423-0891-23 The 1 tube — — FDA listed —
Crest Fresh and White 1.5 mg/g 69423-0897-24 The 1 tube — — FDA listed —
Crest 3D White Glamorous White 1.6 mg/g 69423-0914-02 The 2 tubes — — FDA listed —
Crest Complete Plus Scope Outlast Ultra 1.5 mg/g 69423-0918-65 The 1 tube — — FDA listed —
Crest Complete Plus Active Fresh plus Whitening Scope 1.5 mg/g 69423-0932-55 The 1 tube — — FDA listed —
Crest Complete plus Whitening plus Scope 1.5 mg/g 69423-0933-02 The 2 tubes — — FDA listed —
Crest Premium Plus Active Foam Whitening scope 1.5 mg/g 69423-0949-52 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Polishing Mint 1.5 mg/g 69423-0958-23 The 1 tube — — Discontinued —
Burts Bees Deep Clean plus Whitening 1.3 mg/g 69423-0961-47 Procter 1 tube — — FDA listed —
Burts Bees Extra White 1.3 mg/g 69423-0962-47 Procter 1 tube — — FDA listed —
Crayola ANTICAVITY BUBBLE GUM FLAVOR .243 g/100g 70108-0076-01 Ashtel 1 tube — — FDA listed —
Crayola ANTICAVITY STRAWBERRY FLAVOR .243 g/100g 70108-0080-01 Ashtel 1 tube — — FDA listed —
Crayola ANTICAVITY WATERMELON FLAVOR .243 g/100g 70108-0081-01 Ashtel 1 tube — — FDA listed —
Barbie Bubble Gum ANTICAVITY FLUORIDE .243 g/100g 70108-0082-01 Ashtel 1 tube — — FDA listed —
Brush Buddies - Hot Wheels ANTICAVITY FLUORIDE .243 g/100g 70108-0083-01 Ashtel 1 tube — — FDA listed —
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR .243 g/100g 70108-0102-01 Ashtel 1 tube — — FDA listed —
Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE .243 g/100g 70108-0112-01 Ashtel 1 tube — — FDA listed —
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride .243 g/100g 70108-0235-01 Ashtel 1 tube — — FDA listed —
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride .243 g/100g 70108-0236-01 Ashtel 1 tube — — FDA listed —
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride .243 g/100g 70108-0237-01 Ashtel 1 tube — — FDA listed —
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride .243 g/100g 70108-0238-01 Ashtel 1 tube — — FDA listed —
Aru Cavity Protection .243 g/100g 70108-0287-01 Ashtel 1 tube — — FDA listed —
Dentisse 1.1 mg/g 70683-0703-02 Dentisse, 91 g — — FDA listed —
dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum .243 g/100g 71141-0184-10 Lidl 1 tube — — FDA listed —
dentalux ANTI-CAVITY FLUORIDE WHITENING MINT .243 g/100g 71141-0185-10 Lidl 1 tube — — FDA listed —
Equate Sculpted White TP Equate Sculpted White TP .15 g/100g 79903-0282-87 Walmart 107 g — — FDA listed —
AutoBrush bubblegum .243 g/100g 82913-0005-01 Lander 1 tube — — FDA listed —
AutoBrush Mint .243 g/100g 82913-0006-01 Lander 1 tube — — FDA listed —
Watermelon Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0337-10 HISMILE 100 g — — FDA listed —
Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0338-10 HISMILE 100 g — — FDA listed —
Strawberry Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0339-10 HISMILE 100 g — — FDA listed —
Classic Mint Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0340-10 HISMILE 100 g — — FDA listed —
Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0341-10 HISMILE 100 g — — FDA listed —
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g 83013-0344-10 HISMILE 100 g — — FDA listed —
Crest 3D White Brilliance Bright Mint 1.5 mg/g 84126-0601-43 Procter 1 tube — — FDA listed —
Crest Complete plus Scope Pro Advanced Freshness 1.5 mg/g 84126-0614-01 The 1 tube — — FDA listed —
Crest 3D White Sparkle Mint 1.5 mg/g 84126-0620-24 The 1 tube — — FDA listed —
Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam 1.5 mg/g 84126-0628-04 The 1 cello — — FDA listed —
Crest 3D White Advanced Radiant Mint with Stain Blasting Foam 1.5 mg/g 84126-0629-02 The 1 cello — — FDA listed —
Crest 3D White Advanced Deep Clean with Stain-Blasting Foam 1.5 mg/g 84126-0631-33 The 1 tube — — FDA listed —
Crest 3D White Advanced Glamorous White with Stain-Blasting Foam 1.5 mg/g 84126-0632-03 The 1 cello — — FDA listed —
Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep 1.5 mg/g 84126-0633-37 The 1 tube — — FDA listed —
Crest 3D White Advanced Charcoal with Stain-Blasting Foam 1.5 mg/g 84126-0634-03 The 1 cello — — FDA listed —
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint 1.5 mg/g 84126-0635-02 The 2 tubes — — FDA listed —
Crest 3D White Stain Eraser Daily Stain Prevention Polishing Mint 1.5 mg/g 84126-0636-38 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint 1.5 mg/g 84126-0637-23 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Luxe Mint 1.5 mg/g 84126-0645-23 The 1 tube — — FDA listed —
Crest 3D White Stain Eraser Mint Splash 1.5 mg/g 84126-0646-23 The 1 tube — — FDA listed —
Crest 3D White Ultra Whitening with Stain-Blasting Foam Vivid Mint 1.5 mg/g 84126-0653-05 The 1 cello — — FDA listed —
Crest Plus Cinnamon plus Whitening 1.5 mg/g 84126-0655-23 The 1 tube — — FDA listed —
Crest Plus Deep Clean plus Whitening 1.5 mg/g 84126-0656-23 The 1 tube — — Discontinued —
Crest Plus Scope plus Whitening with Mouthwash 1.5 mg/g 84126-0658-23 The 1 tube — — FDA listed —
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash 1.5 mg/g 84126-0659-23 The 1 tube — — FDA listed —
Crest Premium Plus Active Foam Whitening scope 1.5 mg/g 84126-0660-03 The 3 tubes — — FDA listed —
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint 1.5 mg/g 84126-0661-03 The 3 tubes — — FDA listed —
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint 1.5 mg/g 84126-0662-52 The 1 tube — — FDA listed —
Crest Plus Scope plus Whitening Outlast Mint 1.5 mg/g 84126-0663-02 The 2 tubes — — FDA listed —
Crest Plus Scope plus Whitening Outlast Mint 1.5 mg/g 84126-0664-23 The 1 tube — — FDA listed —
Crest Plus Active Fresh Scope plus Whitening 1.5 mg/g 84126-0665-04 The 1 cello — — FDA listed —
Crest Plus Extra Whitening 1.5 mg/g 84126-0666-54 The 1 tube — — FDA listed —
Pop On Toothpaste. .243 g/100g 87409-0001-01 POPONSMILES,LLC 60 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

🏛️
2010
On the market since
Apr 2010
📍
2026
Currently FDA-listed
16 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 Whitening Tooth Polish (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization379
Death347
Life-threatening84
Disabling79
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 213 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
54473-0301-04 You're viewing this 108 g in 1 TUBE (54473-301-04) 2018-01-01 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 54473-301-04, 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: 54473-0301-04, written without dashes as 54473030104. 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 54473-0301-04, the first segment (54473) is the labeler code FDA assigned to Melaleuca, Inc.; the middle segment (0301) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Melaleuca, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Melaleuca, Inc. 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 8 words ▾

Use aids in the prevention of dental cavities

⏱️ Dosage and Administration 68 words ▾

Directions adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 2 years of age: consult a dentist or physician

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 5 words ▾

Active ingredient Sodium Fluoride (0.243%)

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol

🎯 Purpose 2 words ▾

Purpose Anticavity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54473-0300-04 · Melaleuca, 54473-0302-04 · Melaleuca, →
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.