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Zohar Anti Cavity Mouthwash Fresh Mint Flavour SODIUM FLUORIDE .2 mg/mL Liquid, 500 mL — NDC 84045-0003-00 package photo

Zohar Anti Cavity Mouthwash Fresh Mint Flavour SODIUM FLUORIDE .2 mg/mL Liquid, 500 mL

by ZOHAR KOSHER LIMITED · 500 mL in 1 BOTTLE (84045-003-00)
NDC 84045-0003-00
🏷️ FDA NDC (as labeled) 84045-003-00 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. 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

FDA NDC (as labeled) 84045-003-00
Product NDC 84045-003
11-digit billing NDC 84045000300
RxCUI 240698
UNII 8ZYQ1474W7
UPC 5012741045023
Application # M021
SPL Set ID c7d29e98-50f3-4f77-bebb-30d911864843
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2024-03-15
Route DENTAL
Dosage form LIQUID
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 84045-003-00 — 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 → 84045-0003-00. 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

LabelerZOHAR KOSHER LIMITED
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code84045
First marketedMar 2024
Product typeHuman Otc Drug
Portfolio6 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

🧪 What is this product?

This is an over-the-counter mouthwash rinse marketed under FDA's OTC monograph rules for oral care products. Sodium fluoride, the active ingredient, is commonly used in dental rinses to help strengthen tooth enamel and reduce cavity formation. The product is a liquid intended for rinsing or swishing in the mouth and comes in a fresh mint flavor.

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.

🧪 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 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 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 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 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 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 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.

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

The official label also statesWater, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1, FD&C Yellow#6.

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint .5 mg/mL 00135-0449-01 Haleon 500 ml — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh .5 mg/mL 00135-0451-01 Haleon 500 ml — — FDA listed —
TheraBreath for Kids Anticavity Wacky Watermelon .5 mg/mL 10237-0255-10 Church 296 ml — — FDA listed —
TheraBreath for Kids Anticavity Strawberry Splash .5 mg/mL 10237-0256-10 Church 296 ml — — FDA listed —
Therabreath Overnight Chamomile Mint 5 mg/10mL 10237-0262-16 Church 473 ml — — FDA listed —
TheraBreath AM-PM Twin Pack 10237-0268-01 Church 1 kit — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 11344-0004-44 Nice-Pak 532 ml — — FDA listed —
Anticavity .2 mg/mL 11673-0004-77 Target 500 ml — — FDA listed —
Fluoride Mouth Rinse Anticavity .2 mg/mL 11673-0213-44 Target 532 ml — — FDA listed —
Anticavity Rinse .5 mg/mL 11822-4004-04 Rite 532 ml — — FDA listed —
Anticavity .2 mg/mL 30142-0004-77 The 500 ml — — FDA listed —
Hello Wild Strawberry .02 g/100mL 35000-0685-10 Colgate-Palmolive 473 ml — — FDA listed —
Hello Unicorn Splash unicorn splash anticavity fluoride rinse .02 g/100mL 35000-0687-10 Colgate-Palmolive 473 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 36800-0004-44 Topco 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 36800-0213-44 Topco 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 37808-0213-44 H 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 37808-0808-44 H 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 41163-0213-44 United 532 ml — — FDA listed —
ACT Kids Pure Protect Anticavity- Simply Strawberry .5 mg/mL 41167-0915-00 Chattem, 500 ml — — FDA listed —
ACT Anticavity Fluoride Arctic Blast .2 mg/mL 41167-0937-02 Chattem, 532 ml — — FDA listed —
ACT Kids Anticavity Fluoride Wild Watermelon .5 mg/mL 41167-0938-01 Chattem, 500 ml — — FDA listed —
ACT Anticavity Fluoride Cinnamon .2 mg/mL 41167-0940-08 Chattem, 532 ml — — FDA listed —
ACT Anticavity Fluoride Mint .2 mg/mL 41167-0942-01 Chattem, 30 ml — — FDA listed —
ACT Anticavity Fluoride Kids Bubblegum .2 mg/mL 41167-0944-01 Chattem, 30 ml — — FDA listed —
ACT Anticavity Fluoride Kids Groovy Grape .2 mg/mL 41167-0945-00 Chattem, 500 ml — — FDA listed —
ACT Kids Anticavity Fluoride Pineapple Punch .2 mg/mL 41167-0953-05 Chattem, 500 ml — — FDA listed —
ACT Restoring Anticavity Fluoride Cool Mint .2 mg/mL 41167-0957-05 Chattem, 532 ml — — FDA listed —
ACT Total Care Anticavity Fluoride Fresh Mint .2 mg/mL 41167-0961-00 Chattem, 532 ml — — FDA listed —
ACT Total Care Anticavity Fluoride Icy Clean Mint .2 mg/mL 41167-0965-00 Chattem, 532 ml — — FDA listed —
ACT Kids Berry Blast .5 mg/mL 41167-0976-00 Chattem, 500 ml — — FDA listed —
ACT Restoring Anticavity Fluoride Mint Burst .5 mg/mL 41167-0979-00 Chattem, 532 ml — — Discontinued —
Anticavity Rinse .2 mg/mL 41250-0004-44 Meijer, 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 41250-0213-44 Meijer, 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 49035-0004-44 Walmart 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 53942-0004-44 Demoulas 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 53942-0213-44 Demoulas 532 ml — — FDA listed —
Kids Flouride Rinse .2 mg/mL 55301-0004-44 Your 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 55301-0213-44 Your 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 55319-0004-44 Family 532 ml — — FDA listed —
Anticavity .2 mg/mL 55910-0030-77 Old 500 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 59779-0004-77 CVS 500 ml — — FDA listed —
Anticavity .2 mg/mL 59779-0213-44 CVS 532 ml — — FDA listed —
Maintenance Rinse Mint 226 ug/mL 61578-0311-01 Dental 473 ml — — FDA listed —
Maintenance Rinse Citrus 226 ug/mL 61578-0312-01 Dental 473 ml — — FDA listed —
Maintenance Rinse Grape 226 ug/mL 61578-0313-01 Dental 473 ml — — FDA listed —
Treatment Rinse Mint 226 ug/mL 61578-0314-01 DENTAL 2 bottles — — FDA listed —
Treatment Rinse Apple 226 ug/mL 61578-0315-01 DENTAL 2 bottles — — FDA listed —
Cavity Protection Fresh Mint Anticavity Mouthwash .5 mg/mL 63615-0001-01 Oxyfresh 473 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 63941-0170-44 Valu 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 63941-0904-77 Valu 500 ml — — FDA listed —
Firefly Anticavity Fluoride .5 mg/mL 66923-0003-34 Ranir 237 ml — — Discontinued —
Firefly Anticavity Fluoride .5 mg/mL 66923-0007-00 Ranir 473 ml — — FDA listed —
Firefly Anticavity Fluoride .5 mg/mL 66923-0111-43 Ranir 473 ml — — FDA listed —
PerCara Kids Bubble Gum .05 g/100mL 67933-0016-01 LEC 532 ml — — FDA listed —
Quip Anticavity Fluoride Concentrate .05 g/100mL 69261-0005-03 Quip 117.5 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR .05 g/100mL 70108-0091-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR .05 g/100mL 70108-0092-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR .05 g/100mL 70108-0093-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor .05 g/100mL 70108-0094-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR .05 g/100mL 70108-0095-01 Ashtel 355 ml — — FDA listed —
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR .05 g/100mL 70108-0103-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Oral Rinse Sparkle Mint .2 mg/mL 70108-0206-01 ASHTEL 473 ml — — FDA listed —
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE .05 g/100mL 70108-0210-01 Ashtel 296 ml — — FDA listed —
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike Strawberry .05 g/100mL 70108-0314-01 Ashtel 355 ml — — FDA listed —
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELON .05 g/100mL 70108-0315-01 Ashtel 355 ml — — FDA listed —
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey Punch .05 g/100mL 70108-0316-01 Ashtel 355 ml — — FDA listed —
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard Berry .05 g/100mL 70108-0317-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRY .05 g/100mL 70108-0318-01 Ashtel 355 ml — — FDA listed —
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape .05 g/100mL 70108-0319-01 Ashtel 355 ml — — FDA listed —
GuruNanda Anti-Cavity .2 mg/mL 70708-0890-16 GURUNANDA, 473 ml — — FDA listed —
GuruNanda Anticavity .2 mg/mL 70708-0927-16 GURUNANDA, 499 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 72036-0213-44 HARRIS 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 72288-0004-77 Amazon.com 500 ml — — Discontinued —
Anticavity Fluoride Rinse .2 mg/mL 72288-0213-44 Amazon.com 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 72476-0204-44 Retail 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 72476-0213-44 Retail 532 ml — — FDA listed —
EverSmile Squirt .05 g/100mL 72655-0702-01 Everbrands, 100 ml — — FDA listed —
Cool sense Care Plus .05 g/100mL 73242-1121-01 DONG 250 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0033-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Watermelon .05 g/100mL 73928-0036-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Bubblegum .05 g/100mL 73928-0037-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0038-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Brbie Anticavity Fluoride Bubblegum .05 g/100mL 73928-0039-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0046-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0047-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Brbie Anticavity Fluoride Bubblegum .05 g/100mL 73928-0048-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Squishmallows Anticavity Fluoride Mint Falvor .05 g/100mL 73928-0050-01 Kingkey 355 ml — — FDA listed —
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash .05 g/100mL 73928-0051-01 Kingkey 296 ml — — FDA listed —
Brush Buddies Mouthwash 12oz Star Wars Saber Strike Strawberry .05 g/100mL 73928-0130-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Disney Cars Chow Cherry .05 g/100mL 73928-0131-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Frozen Blizzard Berry .05 g/100mL 73928-0132-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Disney Princesses Grand Grape .05 g/100mL 73928-0133-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch .05 g/100mL 73928-0134-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Toy Story Wild West Watermelon .05 g/100mL 73928-0135-01 Kingkey 355 ml — — FDA listed —
Anticavity fluoride rinse .2 mg/mL 76162-0838-38 Topco 296 ml — — FDA listed —
Cool sense Care Plus .05 g/100mL 76670-0013-01 DOCSMEDI 250 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 79481-0201-01 Meijer, 532 ml — — FDA listed —
Anticavity fluoride rinse .2 mg/mL 79481-0838-01 Meijer, 296 ml — — FDA listed —
Anticavity .2 mg/mL 79903-0033-44 Walmart 532 ml — — FDA listed —
Target Up And Up Anticavity .05 g/100mL 82442-0106-16 TARGET 473 ml — — FDA listed —
Dentalclean Blue Diamond Alcohol Free Mouthwash .2 mg/mL 84035-0009-01 Rabbit 1000 ml — — FDA listed —
Dentalclean Green Diamond Alcohol Free Mouthwash .2 mg/mL 84035-0012-20 Rabbit 1000 ml — — FDA listed —
Zohar Anti Cavity Mouthwash Coolmint Flavour .2 mg/mL 84045-0001-00 ZOHAR 500 ml — — Discontinued —
Zohar Anti Cavity Mouthwash Bubble Gum Flavour .2 mg/mL 84045-0002-00 ZOHAR 250 ml — — Discontinued —
Zohar Anti Cavity Mouthwash Fresh Mint Flavour .2 mg/mLthis 84045-0003-00 ZOHAR 500 ml — — Discontinued —
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
Mar 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.

🔬 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 SODIUM FLUORIDE — the ingredient across all brands.

Top reported reactions

Fatigue367
Nausea343
Pain305
Diarrhoea300
Vomiting263
Pneumonia246
Dizziness244

Age at onset

Infant5
Child31
Adolescent20
Adult287
Elderly246

Reporter sex

4,794 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization1,047
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 760 107
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
84045-0003-00 You're viewing this 500 mL in 1 BOTTLE (84045-003-00) 2024-03-15 Inactivated by FDA

🧭 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 FDA registers it as 84045-003-00, 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: 84045-0003-00, written without dashes as 84045000300. 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 84045-0003-00, the first segment (84045) is the labeler code FDA assigned to ZOHAR KOSHER LIMITED; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
ZOHAR KOSHER LIMITED 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 89 words ▾

Directions Adults and children 6 years of age and older: use once 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 untill capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.

⚠️ Warnings 27 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.

🧪 Active Ingredient 11 words ▾

Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion) Purpose Anticavity

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1, FD&C Yellow#6.

🎯 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 ↗
← 84045-0002-00 · ZOHAR 84045-0004-00 · ZOHAR →
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.