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SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh sodium fluoride .5 mg/mL Liquid, 500 mL — NDC 00135-0451-01 package photo

SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh sodium fluoride .5 mg/mL Liquid, 500 mL

by Haleon US Holdings LLC · 500 mL in 1 BOTTLE (0135-0451-01)
NDC 00135-0451-01
🏷️ FDA NDC (as labeled) 0135-0451-01 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0135-0451-01
Product NDC 0135-0451
11-digit billing NDC 00135045101
RxCUI 240698
UNII 8ZYQ1474W7
Application # M022
SPL Set ID 817c0dad-d109-428e-adb5-3354604acc94
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-02
Route ORAL
Dosage form LIQUID
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 0135-0451-01 — a 4-4-2 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 labeler segment → 00135-0451-01. 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.

🏭 Manufacturer & labeler

LabelerHaleon US Holdings LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio404 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?

Sensodyne Pronamel Intensive Enamel Repair Extra Fresh is an over-the-counter oral liquid rinse containing sodium fluoride. This product is a monograph drug marketed under FDA's established rules for fluoride rinses. Sodium fluoride is commonly used in oral care products to help strengthen tooth enamel and reduce tooth sensitivity. The liquid form is typically used as a rinse applied directly to the teeth.

Supplement & herbal interactions

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

💊 What it looks like

Color Blue
FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 25IH6R4SGF
    Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 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 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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 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.

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

The official label also stateswater, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 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 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
Sodium Fluoride .5 mg/mL 58657-0322-50 Method 50 ml $0.156 — Availability likely —
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/mLthis 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/mL 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
Jan 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
00135-0451-01 You're viewing this 500 mL in 1 BOTTLE (0135-0451-01) 2024-01-02 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 0135-0451-01, 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: 00135-0451-01, written without dashes as 00135045101. 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 00135-0451-01, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0451) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Haleon US Holdings 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 32 words ▾

Uses • aids in the prevention of dental cavities. • the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

⏱️ Dosage and Administration 130 words ▾

Directions • adults and children 6 years of age and older: • use once a day after brushing your teeth with a toothpaste. • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. • do not swallow the rinse. • do not drink from the bottle. • do not rinse mouth with water. • 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 27 words ▾

Warning 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 9 words ▾

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

🧪 Inactive Ingredients 68 words ▾

Inactive ingredients (Clean Mint) water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate

Inactive ingredients (Extra Fresh) water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 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 ↗
← 00135-0450-01 · Haleon 00135-0456-01 · Haleon →
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.