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365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity .1 mg/mL Mouthwash, 500 mL — NDC 42681-0048-1 (Billing 42681-0048-01)

by WHOLE FOODS · 500 mL in 1 BOTTLE

This is a package of 500 mL of 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity .1 mg/mL Mouthwash from WHOLE FOODS, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 42681-0048-01
🏷️ FDA NDC (as labeled) 42681-0048-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42681-0048-1
Product NDC 42681-0048
11-digit billing NDC 42681004801
RxCUI 313029
UNII Q80VPU408O
Application # M022
SPL Set ID 25bc7ab1-116d-143a-e063-6394a90aa970
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-31
Route ORAL
Dosage form MOUTHWASH
Substance FLUORIDE ION
Quick answers
  • RxCUI (RxNorm): 313029
Why two NDCs? The FDA registers this code as 42681-0048-1 — 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 → 42681-0048-01. 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

📗 Our plain-language guide HelloPharmacist
  • Mostly it helps prevent cavities. Some toothpastes are also labeled for tooth sensitivity (H E B) or for bleeding gums and plaque linked to gingivitis (CVS Pharmacy). Check your pr...
  • For the 365 Whole Foods Market and Equate rinses, use it twice a day after brushing, if you're 6 or older. Swish 10 mL (2 teaspoonfuls) for 1 minute, then spit it out. Don't eat or...
  • Yes, with care. Children under 6 should be taught to spit and be supervised, and many toothpastes call for a pea-sized amount. Check the age directions on your product. Under 2 yea...
  • If more than a normal brushing amount is swallowed, get medical help or call Poison Control right away. Don't wait for symptoms.
📖 Read our full Fluoride guide →

Supplement & herbal interactions

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

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
42681-0048-01 You're viewing this Main listing 500 mL in 1 BOTTLE 2026-05-01 — Active

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/mLthis 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/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 —
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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • UNII 43XOA705ZD
    A chemical compound combining menthol and salicylic acid. In medicines, it's used as a topical counterirritant to produce cooling and warming sensations that may help mask minor pain or discomfort in creams and ointments.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 6TC6NN0876
    A natural sweetener extracted from stevia plant leaves. It sweetens the medicine to improve taste without adding calories, helping make medications easier to take.
  • UNII 3J50XA376E
    Thymol is a natural compound derived from thyme and other plants. It acts as a preservative and flavoring agent in medicines, helping prevent microbial growth and add taste.
  • 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.

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

The official label also statesWater, Alcohol (12%), Sorbitol, Polysorbate 80, Stevia Rebaudiana Leaf Extract, Sodium Benzoate, Natural Flavor, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Citric Acid, Sodium Hydroxide.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerWHOLE FOODS
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code42681
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio2 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 8 words ▾

Use Aids in the prevention of dental cavities

⏱️ Dosage and Administration 92 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 milliliters (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 7 words ▾

Warnings keep out of reach of children.

📦 Storage and Handling 25 words ▾

Other Information. • This rinse is not intended to replace brushing or flossing • 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 25 words ▾

Inactive Ingredients Water, Alcohol (12%), Sorbitol, Polysorbate 80, Stevia Rebaudiana Leaf Extract, Sodium Benzoate, Natural Flavor, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Citric Acid, Sodium Hydroxide.

🎯 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 ↗

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 — Not published for this NDC No photo available yet for this listing.
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 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.
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 WHOLE FOODS. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WHOLE FOODS 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.
← 42681-0047-01 · Whole 42681-0050-01 · Whole →
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.