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Anticavity Sodium fluoride .1 mg/mL Mouthwash, 474 mL — NDC 56062-0435-43 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Anticavity Sodium fluoride .1 mg/mL Mouthwash, 474 mL — NDC 56062-435-43 (Billing 56062-0435-43)

by Publix Super Markets, Inc. · 474 mL in 1 BOTTLE, PLASTIC

This is a package of 474 mL of Anticavity Sodium fluoride .1 mg/mL Mouthwash from Publix Super Markets, Inc., no longer marketed (first marketed Sep 2015), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 56062-0435-43
🏷️ FDA NDC (as labeled) 56062-435-43 billing pads the product segment with a zero
This package
Contains474 mL Pack sizes2 compare ↓
Main listing for product 56062-435 · Also comes in: 946 ml 56062-435-45
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 56062-435-43
Product NDC 56062-435
11-digit billing NDC 56062043543
RxCUI 313029
UNII 8ZYQ1474W7
UPC 0041415091726
Application # M021
SPL Set ID 14494238-872b-49e2-8bf7-df3844a0a6c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2015-09-15
Route ORAL
Dosage form MOUTHWASH
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 313029
Why two NDCs? The FDA registers this code as 56062-435-43 — 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 → 56062-0435-43. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Caries prophylactic agents class.

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

Clinical

📖 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 an over-the-counter mouthwash product containing sodium fluoride. It is sold under the FDA's OTC monograph rules for anticavity rinses rather than as an individually approved product. Sodium fluoride is commonly used in oral rinses to help strengthen tooth enamel and reduce tooth decay risk when used as directed for rinsing.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer 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.
Try another pack size: 946 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
56062-0435-43 You're viewing this Main listing 474 mL in 1 BOTTLE, PLASTIC 2015-09-15 — Discontinued by firm
56062-0435-45 56062-435-45 946 mL in 1 BOTTLE, PLASTIC 2015-09-15 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 474 mL — 474 ml in 1 bottle, plastic.
How does this package differ from NDC 56062-0435-45?
Both are Anticavity Sodium fluoride .1 mg/mL Mouthwash — the drug itself is identical. This page's package is the 474 mL one, while NDC 56062-0435-45 is the 946 ml package.
What NDC number is used to bill for this package of Anticavity Sodium fluoride .1 mg/mL Mouthwash?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride 2 mg/10mL 00126-0032-46 Colgate 500 ml — — FDA listed —
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride 2 mg/10mL 00126-0034-46 Colgate 500 ml — — FDA listed —
Anticavity .1 mg/mL 00363-0171-86 Walgreen 1000 ml — — Discontinued —
Anticavity Fluoride Rinse .1 mg/mL 11673-0163-86 Target 1000 ml — — FDA listed —
Anticavity .2 mg/mL 11822-9718-06 Rite 1000 ml — — FDA listed —
Anticavity .2 mg/mL 30142-0163-86 The 1000 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 30142-0482-86 The 1000 ml — — FDA listed —
Colgate Kids Unicorn Alcohol Free .1 mg/mL 35000-0334-84 Colgate-Palmolive 500 ml — — FDA listed —
Colgate Enamel Strength Mouthwash .1 mg/mL 35000-0734-98 Colgate-Palmolive 500 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 36800-0482-86 Topco 1000 ml — — FDA listed —
Anticavity .1 mg/mL 36800-0803-43 Topco 474 ml — — FDA listed —
Anticavity .1 mg/mL 36800-0971-86 Topco 1000 ml — — FDA listed —
Kids Crest Bubblegum Rush .1 mg/mL 37000-0167-05 The 500 ml — — FDA listed —
Crest Pro-Health Advanced w/Extra Whitening .1 mg/mL 37000-0867-01 The 473 ml — — FDA listed —
Anticavity .1 mg/mL 37808-0119-86 H 1000 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 37808-0163-77 H 500 ml — — Discontinued —
Anticavity .1 mg/mL 37808-0435-45 H 946 ml — — FDA listed —
Alcohol Free Refreshing Mint .1 mg/mL 37808-0576-86 H 1000 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 37808-0942-86 H 1000 ml — — FDA listed —
Anticavity .1 mg/mL 41163-0011-45 United 946 ml — — FDA listed —
Anticavity .2 mg/mL 41163-0581-86 United 1000 ml — — FDA listed —
Anticavity .1 mg/mL 41163-0971-86 United 1000 ml — — FDA listed —
Act Total Care Anticavity Fluoride Fresh Mint .09 mg/mL 41167-0943-03 Chattem, 1000 ml — — FDA listed —
ACT Total Care Anticavity Fluoride Icy Clean Mint .09 mg/mL 41167-0966-07 Chattem, 1000 ml — — FDA listed —
ACT Total Care Dry Mouth Anticavity Mouth .09 mg/mL 41167-0968-00 Chattem, 532 ml — — FDA listed —
ACT Restoring Anticavity Fluoride Mint Burst .2 mg/mL 41167-0978-01 Chattem, 30 ml — — FDA listed —
ACT Restoring Anticavity Fluoride Cool Mint .09 mg/mL 41167-0981-07 Chattem, 1000 ml — — FDA listed —
ACT Whitening Anticavity Gentle Mint .09 mg/mL 41167-0983-02 Chattem, 500 ml — — FDA listed —
Anticavity .2 mg/mL 41250-0163-86 Meijer, 1000 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 41250-0482-86 Meijer, 1000 ml — — FDA listed —
Oral Antivavity .1 mg/mL 41250-0576-86 Meijer, 1000 ml — — FDA listed —
Anticavity .2 mg/mL 41250-0581-86 Meijer, 1000 ml — — FDA listed —
Anticavity .1 mg/mL 41250-0971-86 Meijer, 1000 ml — — FDA listed —
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity .1 mg/mL 42681-0048-01 WHOLE 500 ml — — FDA listed —
Anticavity .1 mg/mL 49035-0163-86 Walmart 1000 ml — — FDA listed —
Anticavity .2 mg/mL 49035-0581-86 Walmart 1000 ml — — FDA listed —
Anticavity .1 mg/mL 49035-0971-86 Walmart 1000 ml — — FDA listed —
Toms Whole Care Mouthwash Fresh Mint 1 mg/10mL 51009-0837-52 Tom's 473 ml — — FDA listed —
Anticavity .2 mg/mL 53942-0163-86 Demoulas 1000 ml — — FDA listed —
Glowing White .1 mg/mL 53942-0435-45 Demoulas 946 ml — — FDA listed —
Sodium fluoride .2 mg/mL 53942-0581-86 Demoulas 1000 ml — — FDA listed —
Anticavity .1 mg/mL 53942-0971-86 Demoulas 1000 ml — — FDA listed —
Anticavity .1 mg/mL 55301-0435-43 Your 473 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 55301-0482-86 Your 1000 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 55319-0163-86 Family 1000 ml — — FDA listed —
Anticavity .1 mg/mL 55910-0163-86 Old 1000 ml — — Discontinued —
Anticavity .1 mg/mL 55910-0971-86 Old 1000 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 56062-0163-86 Publix 1000 ml — — FDA listed —
Anticavity .1 mg/mLthis 56062-0435-43 Publix 474 ml — — Discontinued —
Anticavity .1 mg/mL 56062-0971-86 Publix 1000 ml — — FDA listed —
Plaque Refresh Remineralizing Rinse Fresh Mint .1 mg/mL 57660-0003-01 TJA 473 ml — — Discontinued —
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse .02 g/100mL 58578-0517-01 Rowpar 1 bottle — — FDA listed —
Anticavity .1 mg/mL 59450-0971-86 The 1000 ml — — FDA listed —
Crest Pro-Health Advanced Complete Care Anticavity Fluoride .1 mg/mL 69423-0751-01 The 1000 ml — — FDA listed —
Crest 3D White Brilliance Pro Rinse .1 mg/mL 69423-0838-32 The 946 ml — — FDA listed —
Crest Braces Care Anticavity Fluoride Rinse .1 mg/mL 69423-0881-16 The 475 ml — — FDA listed —
Crest Pro Health Densify Rinse .1 mg/mL 69423-0882-32 The 946 ml — — FDA listed —
Kids Crest Strawberry Rush .1 mg/mL 69423-0895-16 The 500 ml — — FDA listed —
Anticavity .1 mg/mL 69842-0548-86 CVS 1000 ml — — FDA listed —
sodium fluoride rinse .1 mg/mL 69892-0971-86 Rockland 1000 ml — — FDA listed —
Listerine Total Care Fresh Mint Anticavity .1 mg/mL 69968-0178-01 Kenvue 250 ml — — Discontinued —
Listerine Total Care Zero Alcohol Anticavity Fresh Mint .1 mg/mL 69968-0194-01 Kenvue 1000 ml — — FDA listed —
Listerine Smart Rinse Berry Splash .1 mg/mL 69968-0606-03 Kenvue 27 ml — — FDA listed —
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash .1 mg/mL 69968-0687-05 Kenvue 500 ml — — FDA listed —
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield .1 mg/mL 69968-0689-05 Kenvue 500 ml — — FDA listed —
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast .1 mg/mL 69968-0690-05 Kenvue 500 ml — — FDA listed —
Listerine Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor .1 mg/mL 69968-0691-05 Kenvue 500 ml — — Discontinued —
Listerine Total Care Fresh Mint Anticavity Fluoride .1 mg/mL 69968-0787-01 Kenvue 1000 ml — — FDA listed —
Listerine Clinical Solutions Teeth Strength Alpine Mint .1 mg/mL 69968-0819-01 Kenvue 1000 ml — — FDA listed —
Listerine Clinical Solutions Enamel Strength Alpine Mint .1 mg/mL 69968-0881-01 Kenvue 1000 ml — — FDA listed —
Listerine Total Care Kids Anticavity Fluoride Rinse Mint Shield .1 mg/mL 69968-0902-05 Kenvue 500 ml — — FDA listed —
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble Blast .1 mg/mL 69968-0903-05 Kenvue 500 ml — — FDA listed —
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash .1 mg/mL 69968-0904-03 Kenvue 27 ml — — FDA listed —
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint .1 mg/mL 69968-0924-01 Kenvue 1000 ml — — FDA listed —
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash .1 mg/mL 69968-0950-01 Kenvue 1000 ml — — FDA listed —
Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash .1 mg/mL 69968-0951-01 Kenvue 1000 ml — — FDA listed —
Listerine Total Care Intense Anticavity Fluoride Mouthwash .1 mg/mL 69968-0952-01 Kenvue 1000 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR .02 g/100mL 70108-0088-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR .02 g/100mL 70108-0089-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR .02 g/100mL 70108-0090-01 Ashtel 355 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 71141-0159-32 Lidl 1000 ml — — FDA listed —
Oral Antivavity .1 mg/mL 72036-0576-86 HARRIS 1000 ml — — FDA listed —
Anticavity .2 mg/mL 72288-0439-43 Amazon.com 473 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 72288-0482-86 Amazon.com 1000 ml — — FDA listed —
Oral Antivavity .1 mg/mL 72288-0576-86 Amazon.com 1000 ml — — FDA listed —
Anticavity .1 mg/mL 72476-0005-86 ADUSA 1000 ml — — FDA listed —
Anticavity .1 mg/mL 72476-0435-43 ADUSA 473 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 72476-0482-86 Retail 1000 ml — — FDA listed —
Anticavity .2 mg/mL 72476-0971-86 Retail 1000 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Watermelon .02 g/100mL 73928-0041-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Strawberry .02 g/100mL 73928-0042-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Bubblegum .02 g/100mL 73928-0043-01 Kingkey 355 ml — — Discontinued —
Oral Antivavity .1 mg/mL 76162-0576-86 Topco 1000 ml — — FDA listed —
Alcohol-Free Anticavity .1 mg/mL 79903-0279-10 Walmart 1000 ml — — FDA listed —
Dentalclean Doctor Duck Kids Flouride Mouthwash .1 mg/mL 84035-0010-20 Rabbit 600 ml — — FDA listed —
Dentalclean Dr. Duck Strawberry flouride Mouthwash .1 mg/mL 84035-0011-20 Rabbit 600 ml — — FDA listed —
Crest Pro-Health Advanced Multi-Protection .1 mg/mL 84126-0600-02 The 2 bottles — — FDA listed —
Crest Deep Cleanse Cavity Defense .1 mg/mL 84126-0607-16 The 475 ml — — FDA listed —
Crest Pro-Health Mouthwash Multi-Protection Strong Mint .1 mg/mL 84126-0647-01 The 1000 ml — — FDA listed —
Crest Pro-Health Multi-Protection plus Extra Whitening .1 mg/mL 84126-0651-01 The 946 ml — — FDA listed —
Crest 3D White Strength Whitening Enamel Protection .1 mg/mL 84126-0652-16 The 946 ml — — FDA listed —
Anticavity mouth rinse Low-foaming Spearmint .02 g/100mL 87649-7180-01 Dyson 400 ml — — FDA listed —
Anticavity .1 mg/mL 55301-0163-86 Your 1000 ml — — FDA listed —
Anticavity .1 mg/mL 41163-0043-86 United 1000 ml — — FDA listed —
Mouth Rinse .1 mg/mL 36800-0001-86 Topco 1000 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 59779-0163-77 CVS 500 ml — — Discontinued —
Mouth Rinse .1 mg/mL 00363-0163-86 Walgreen 1000 ml — — FDA listed —
Crest 3D White Luxe Diamond Strong .1 mg/mL 37000-0862-01 The 473 ml — — FDA listed —
Listerine Whitening Extra Mild Alcohol Free Anticavity Fluoride Mouthwash .1 mg/mL 69968-1008-01 Kenvue 1000 ml — — FDA listed —
sodium fluoride .1 mg/mL 71141-0576-86 Lidl 1000 ml — — 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

🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII BBX060AN9V
    Hydrogen peroxide is a chemical solution used in medicines as a cleansing agent or preservative. It helps prevent bacterial growth and is sometimes used in oral or topical formulations.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • 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 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 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also stateswater, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

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.

Manufacturer & labeler

LabelerPublix Super Markets, Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code56062
First marketedSep 2015
Product typeHuman Otc Drug
Portfolio33 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.

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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use Aids in the prevention of dental cavities

⏱️ Dosage and Administration 89 words ▾

Directions Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor

⚠️ Warnings 4 words ▾

Warnings for this product

🤒 Adverse Reactions 29 words ▾

ADVERSE REACTION Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway Lakeland, FL 33811 publix.com PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK Publix ® DSP-TN-15000 DSP-MO-34 SDS-TN-15012

📦 Storage and Handling 6 words ▾

Other information store at room temperature.

🧪 Active Ingredient 11 words ▾

Active Ingredient Sodium fluoride 0.02% (0.01% w/v fluoride ion) Purpose Anticavity

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 26 words ▾

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 62 words ▾

Principal Display Panel P Antivavity Glowing white Mouthrinse Begins working on contact 5 days to whiter teeth Helps strengthen teeth Kills germs that cause bad breath *Compare to the ingredients of Listerine ® Healthywhite™ Vibrant Anticavity Fluoride Mouthrinse Sealed with printed neckband for your protection IMPORTANT: Read directions for proper use. 32 FL OZ (1 QT) 946 mL image description image description

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

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 Anticavity (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

0 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization379
Death347
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 136 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 946 ml (56062-0435-45). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Publix Super Markets, 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.
← 56062-0432-62 · Publix 56062-0437-71 · Publix →
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.