HomeNDC LookupIngredientsSodium Fluoride › 69968-0902-05
Listerine Total Care Kids Anticavity Fluoride Rinse Mint Shield Sodium .1 mg/mL Mouthwash, 500 mL — NDC 69968-0902-05 package photo

Listerine Total Care Kids Anticavity Fluoride Rinse Mint Shield Sodium .1 mg/mL Mouthwash, 500 mL

by Kenvue Brands LLC · 500 mL in 1 BOTTLE (69968-0902-5)
NDC 69968-0902-05
🏷️ FDA NDC (as labeled) 69968-0902-5 billing pads the package 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 →

🆔 Identity & classification

FDA NDC (as labeled) 69968-0902-5
Product NDC 69968-0902
11-digit billing NDC 69968090205
RxCUI 313029, 1798474
UNII 8ZYQ1474W7
UPC 0312547115797
Application # M021
SPL Set ID 2e01b69a-b8f7-f2b9-e063-6294a90af388
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-11
Route ORAL
Dosage form MOUTHWASH
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 69968-0902-5 — a 5-4-1 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 package segment → 69968-0902-05. 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

LabelerKenvue Brands LLC
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio564 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 an over-the-counter mouthwash rinse containing sodium fluoride, an anticavity ingredient typically used to help strengthen tooth enamel and reduce the risk of dental decay. Marketed as an OTC monograph product, it is formulated for children and flavored with mint. The product is used by rinsing in the mouth and then spitting out.

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.

🧪 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 D9OM4SK49P
    Cetylpyridinium chloride is a chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial growth and extends the shelf life of liquid formulations.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 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 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 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, Sorbitol, Sucralose, Phosphoric Acid, Cetylpyridinium Chloride, Menthol, Disodium Phosphate, Flavor, Yellow 6, Blue 1

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 DailyMedingredient 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 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.
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
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/mL 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/mLthis 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
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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69968-0902-05 You're viewing this 500 mL in 1 BOTTLE (69968-0902-5) 2024-12-11 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 69968-0902-5, 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: 69968-0902-05, written without dashes as 69968090205. 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 69968-0902-05, the first segment (69968) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0902) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kenvue Brands LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as 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 8 words

Use Aids in the prevention of dental cavities

⏱️ Dosage and Administration 90 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 a doctor

⚠️ Warnings 28 words

Warnings 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.

📦 Storage and Handling 13 words

Other information Store at room temperature Cold weather may temporarily cloud this product

🧪 Active Ingredient 9 words

Active ingredient Sodium fluoride 0.02% (0.01% w/v fluoride ion)

🧪 Inactive Ingredients 17 words

Inactive ingredients Water, Sorbitol, Sucralose, Phosphoric Acid, Cetylpyridinium Chloride, Menthol, Disodium Phosphate, Flavor, Yellow 6, Blue 1

🎯 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 ↗
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.