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Opal by Opalescence Complete 1.1 mg/g Gel, Dentifrice — NDC 51206-0313-01 package photo

Opal by Opalescence Complete 1.1 mg/g Gel, Dentifrice

by Ultradent Products, Inc. · 1 TUBE in 1 CARTON (51206-313-01) / 133 g in 1 TUBE
NDC 51206-0313-01
🏷️ FDA NDC (as labeled) 51206-313-01 billing pads the product segment with a zero
This package
Contains133 g in 1 tube Pack sizes2 compare ↓
Also comes in: 133 g 51206-0313-02
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 51206-313-01
Product NDC 51206-313
11-digit billing NDC 51206031301
UNII 3FTR44B32Q
Application # M021
SPL Set ID 249cc46a-dad6-0345-e063-6394a90a4447
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-21
Marketing end 2027-08-14
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance STANNOUS FLUORIDE
Why two NDCs? The FDA registers this code as 51206-313-01 — 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 → 51206-0313-01. 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.

🏭 Manufacturer & labeler

LabelerUltradent Products, Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code51206
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio7 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: Stannous 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?

Opal by Opalescence Complete is a fluoride toothpaste gel sold over the counter as an OTC monograph product. Its active ingredient is stannous fluoride, which is commonly used in dental products to help strengthen tooth enamel and reduce cavities. This dentifrice is applied to teeth by brushing and is a standard fluoride-based oral care product.

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 green
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 HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII KG6KU384XW
    A natural mint flavoring derived from spice extracts. It enhances taste in the medicine to improve palatability and make the product more pleasant to consume.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • 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.
  • UNII K72I3DEX9B
    Zinc citrate is a zinc salt combined with citric acid. It's used in medicines as a source of zinc and sometimes as a buffer to help maintain the product's pH balance.

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

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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 133 g
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 Repair and Protect Extra Fresh 1.1 mg/g 00135-0547-02 Haleon 1 tube — — FDA listed —
SENSODYNE Repair and Protect 1.1 mg/g 00135-0548-01 Haleon 1 tube — — FDA listed —
Sensodyne Complete Protection Extra Fresh 1.1 mg/g 00135-0572-02 Haleon 1 tube — — FDA listed —
Sensodyne Complete Protection 1.1 mg/g 00135-0573-02 Haleon 1 tube — — FDA listed —
SENSODYNE Repair and Protect Whitening 1.1 mg/g 00135-0575-01 Haleon 1 tube — — FDA listed —
parodontax 1.1 mg/g 00135-0598-01 Haleon 1 tube — — FDA listed —
parodontax 1.1 mg/g 00135-0601-01 Haleon 1 tube — — FDA listed —
SENSODYNE Rapid Relief 1.1 mg/g 00135-0621-01 Haleon 1 tube — — FDA listed —
SENSODYNE Rapid Relief 1.1 mg/g 00135-0622-01 Haleon 1 tube — — FDA listed —
parodontax Complete Protection 1.1 mg/g 00135-0627-01 Haleon 1 tube — — FDA listed —
SENSODYNE Rapid Relief 1.1 mg/g 00135-0632-01 Haleon 1 tube — — FDA listed —
parodontax Complete Protection 1.1 mg/g 00135-0634-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair 1.1 mg/g 00135-0637-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair Whitening 1.1 mg/g 00135-0638-03 Haleon 1 tube — — FDA listed —
Parodontax Gum Strengthen and Protect 1.5 mg/g 00135-0655-01 Haleon 1 tube — — FDA listed —
Polident ProPartial 1.5 mg/g 00135-0710-01 Haleon 1 tube — — FDA listed —
parodontax Active Gum Repair Breath Freshener 1.1 mg/g 00135-0737-01 Haleon 1 tube — — FDA listed —
SENSODYNE Sensitivity Gum and Enamel Mint 1.1 mg/g 00135-5022-01 Haleon 1 tube — — FDA listed —
SENSODYNE Sensitivity and Gum Mint 1.1 mg/g 00135-5023-01 Haleon 1 tube — — FDA listed —
SENSODYNE Sensitivity and Gum Whitening 1.1 mg/g 00135-5024-01 Haleon 1 tube — — FDA listed —
Sensodyne Sensitivity And Gum Clean And Fresh 1.1 mg/g 00135-5025-01 Haleon 1 tube — — FDA listed —
Sensodyne Fresh Clean 15 mg/g 00135-5912-01 Haleon 1 tube — — FDA listed —
Sensodyne Whiten and Shine 15 mg/g 00135-5913-01 Haleon 1 tube — — FDA listed —
Walgreens Restore and Defend .15 g/100g 00363-1599-09 Walgreens 1 tube — — FDA listed —
Therabreath Deep Clean .454 g/100g 10237-0270-04 Church 1 tube — — FDA listed —
Therabreath Healthy Gums .454 g/100g 10237-0271-04 Church 1 tube — — FDA listed —
Complete Protection .15 g/100g 11673-0366-09 Target 1 tube — — FDA listed —
Complete Protection TP .15 g/100g 11822-5005-09 Rite 1 tube — — FDA listed —
Gum Detoxify .14 g/100g 11822-5006-09 Rite 1 tube — — FDA listed —
Rite Aid Sensitivity and Gum .15 g/100g 11822-5060-09 Rite 1 tube — — FDA listed —
Rite Aid Sensitive Rapid Protection .15 g/100g 11822-6031-09 Rite 1 tube — — FDA listed —
Restore and Defend Whitening TP .15 g/100g 30142-0256-01 Kroger 1 tube — — FDA listed —
Colgate Total SF Advanced Deep Clean 1.1 mg/g 35000-0169-25 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Clean Mint 1.1 mg/g 35000-0172-14 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total SF Mint Stripe Gel 1.1 mg/g 35000-0174-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening Gel 1.1 mg/g 35000-0175-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0176-14 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Advanced Whitening 1.1 mg/g 35000-0178-14 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total Whitening Fresh Boost 1.1 mg/g 35000-0179-48 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Total Plaque Pro Release Fresh Mint 1.1 mg/g 35000-0180-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Plaque Pro Release Whitening 1.1 mg/g 35000-0181-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Deep Clean 1.1 mg/g 35000-0270-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Advanced Whitening 1.1 mg/g 35000-0271-18 Colgate-Palmolive 1 cello — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 35000-0272-21 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Fresh Mint Stripe 1.1 mg/g 35000-0273-32 COLGATE 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0274-14 COLGATE 1 tube — — FDA listed —
Colgate Total SF Whitening 1.1 mg/g 35000-0275-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total SF Whitening Charcoal 1.1 mg/g 35000-0276-47 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Gum Protect Whitening 1.1 mg/g 35000-0277-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Gum Protect Fresh Mint 1.1 mg/g 35000-0278-63 COLGATE 1 tube — — FDA listed —
Colgate Total Plaque Cleanse 1.1 mg/g 35000-0282-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Sensitivity Mineral Shield 1.1 mg/g 35000-0283-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Enamel Strength 1.1 mg/g 35000-0284-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Active Prevention Clean Mint 1.1 mg/g 35000-0431-25 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Total Whitening Charcoal 1.1 mg/g 35000-0571-32 Colgate-Palmolive 1 tube — — FDA listed —
Hello Mighty Multi tasker 1.1 mg/g 35000-0681-10 Colgate-Palmolive 1 tube — — FDA listed —
Sensitive Whitening Anticavity .15 g/100g 36800-0201-19 Topco 1 tube — — FDA listed —
Crest 3D White Brilliance Daily Cleansing and Whitening System 37000-0863-04 The 1 kit — — FDA listed —
Crest Premium Plus Anti-Bacterial 1.4 mg/g 37000-0992-70 The 1 tube — — FDA listed —
H E B Restore and Defend .15 g/100g 37808-0230-09 HEB 1 tube — — FDA listed —
Meijer Restore and Defend Sensitive .15 g/100g 41250-0530-19 Meijer 1 tube — — FDA listed —
Care One Restore and Defend Sensitive Whitening .15 g/100g 41520-0722-19 Foodhold 1 tube — — FDA listed —
PERIOE POP Sensitivity Care Prebiotic Clean Mint 1.4 mg/g 43136-0601-01 Tai 1 tube — — FDA listed —
PERIOE Microbiome Sensitive Clean Mint 1.4 mg/g 43136-0830-01 Tai 1 tube — — FDA listed —
Enamelon .00454 g/g 48783-0520-08 Premier 1 tube — — FDA listed —
Gum Detoxify .15 g/100g 49035-0174-10 Walmart 1 tube — — FDA listed —
Opal by Opalescence Complete 1.1 mg/gthis 51206-0313-01 Ultradent 1 tube — — FDA listed —
Sensitivity and Gum .15 g/100g 55910-0569-19 DG 1 tube — — FDA listed —
Rexall Restore and Defend Sensitive Whitening 4.54 mg/g 55910-0820-01 Old 1 tube — — FDA listed —
MIPaste One Perio .454 g/100g 61596-0300-10 GC 10 bottles — — FDA listed —
Natural White Sensitivity and Gum .15 g/100g 62721-0003-01 Lornamead 1 tube — — FDA listed —
Total Tp Clean Mint Pst 1.1 mg/g 65954-0833-25 Mission 1 tube — — FDA listed —
Colgate Total SF Clean Mint 1.1 mg/g 67751-0224-01 Navajo 1 tube — — FDA listed —
Crest Pro-Health Densify Sensitive Care 1.5 mg/g 69423-0753-41 The 1 tube — — FDA listed —
Crest Pro-Health Densify Active Repair 1.5 mg/g 69423-0754-35 The 1 tube — — FDA listed —
Crest Pro-Health Densify Pro Intensive Repair 1.5 mg/g 69423-0755-25 The 1 tube — — FDA listed —
Crest Pro-health Gum Detoxify Deep Clean 1.5 mg/g 69423-0756-26 The 1 tube — — FDA listed —
Crest Pro-health Gum Detoxify Deep Clean 1.5 mg/g 69423-0757-37 The 1 tube — — FDA listed —
Crest Pro-Health Gum Detoxify Gentle Whitening 1.5 mg/g 69423-0758-37 The 1 tube — — FDA listed —
Crest Pro Health Enamel Repair and Gum Intensive Clean 1.5 mg/g 69423-0761-37 The 1 tube — — FDA listed —
Crest Pro Health Gum Detoxify and Restore Pro Deep Clean 1.5 mg/g 69423-0763-25 The 1 tube — — FDA listed —
Crest Pro Health Gum Detoxify and Restore Pro Whitening 1.5 mg/g 69423-0764-35 The 1 tube — — FDA listed —
Crest Pro-Health Sensitive and Gum All Day Protection 1.5 mg/g 69423-0765-16 The 1 cello — — Discontinued —
Crest Pro Health Enamel Repair and Gum Advanced Whitening 1.5 mg/g 69423-0766-26 The 1 tube — — FDA listed —
Crest Pro Health Clean Mint 1.5 mg/g 69423-0781-43 The 1 tube — — FDA listed —
Crest Pro Health Clean and Free 1.5 mg/g 69423-0782-43 The 1 tube — — FDA listed —
Crest Pro Health Sensitive and Enamel Shield 1.5 mg/g 69423-0783-26 The 1 tube — — FDA listed —
Crest Pro Health with a Touch of Scope 1.5 mg/g 69423-0784-43 The 1 tube — — FDA listed —
Crest Pro Health Whitening Gel 1.5 mg/g 69423-0786-43 The 1 tube — — FDA listed —
Crest Pro Health Advanced Antibacterial Protection 1.4 mg/g 69423-0857-50 The 1 tube — — FDA listed —
Crest Pro Health Advanced Whitening Charcoal 1.4 mg/g 69423-0860-46 The 1 tube — — FDA listed —
Crest Pro Health Advanced Whitening Intensive Cleaning 1.4 mg/g 69423-0861-58 The 1 tube — — FDA listed —
KIDS Crest Advanced Enamel Plus Cavity Protection 1.5 mg/g 69423-0862-41 The 1 tube — — FDA listed —
Crest Pro Health Advanced Gum Protection 1.6 mg/g 69423-0867-35 The 1 tube — — FDA listed —
Crest Pro Health Advanced Sensitive Relief 1.6 mg/g 69423-0868-10 The 1 cello — — Discontinued —
Crest Pro Health Advanced Deep Clean Mint 1.6 mg/g 69423-0869-35 The 1 tube — — FDA listed —
Crest Densify Daily Protection 1.5 mg/g 69423-0873-41 The 1 tube — — FDA listed —
Crest Densify Daily Whitening 1.5 mg/g 69423-0875-41 The 1 tube — — FDA listed —
Crest Pro Health Advanced Enamel Restore 1.6 mg/g 69423-0877-51 The 1 tube — — FDA listed —
Crest Braces Care Cavity Protection 1.4 mg/g 69423-0879-46 The 1 tube — — Discontinued —
Crest Premium Plus Breath Bacteria Blast 1.4 mg/g 69423-0912-52 The 1 tube — — FDA listed —
Crest Pro-Health Advanced Gum Restore Deep Clean 1.4 mg/g 69423-0925-27 The 1 tube — — FDA listed —
Crest Pro-Health Advanced Gum Restore Whitening 1.4 mg/g 69423-0926-37 The 1 tube — — FDA listed —
Crest Pro Health Breath Purify and Gum Deep Clean 1.4 mg/g 69423-0935-41 The 1 tube — — FDA listed —
Crest Pro-Health Advanced Extra Whitening 1.6 mg/g 69423-0938-35 The 1 tube — — FDA listed —
Crest Pro-Health Gum Detoxify Ultra 1.4 mg/g 69423-0952-52 The 1 tube — — FDA listed —
Crest Pro-Health Bacteria Shield and Gum Deep Clean 1.4 mg/g 69423-0956-41 The 1 tube — — Discontinued —
CVS Restore and Defend Sensitive Whitening .454 g/100g 69842-0218-19 CVS 1 tube — — FDA listed —
CVS Pharmacy Restore and Defend .15 g/100g 69842-0251-19 CVS 1 tube — — FDA listed —
CVS Rapid Protection Sensitive .15 g/100g 69842-0252-19 CVS 1 tube — — FDA listed —
CVS Complete Protection .15 g/100g 69842-0549-99 CVS 1 tube — — FDA listed —
CVS Sens Whtng .15 g/100g 69842-0563-39 CVS 1 tube — — FDA listed —
Gum Detoxify .14 g/100g 69842-0948-89 CVS 1 tube — — FDA listed —
Aru Gum Health .11 g/100g 70108-0288-01 Ashtel 1 tube — — FDA listed —
Curodont Protect .14 g/100g 72247-0107-10 CREDENTIS 10 tubes — — FDA listed —
SmileSense .11 g/100g 72644-0639-01 SGII, 108 g — — FDA listed —
Gum Detoxify .14 g/100g 79481-0121-09 Meijer, 1 tube — — FDA listed —
Gum Detoxify .14 g/100g 79903-0025-59 Walmart 116 g — — FDA listed —
Equate Repair and Protect .15 g/100g 79903-0082-29 Walmart 1 tube — — FDA listed —
Equate Optimal Care TP Equate Optimal Care TP .16 g/100g 79903-0280-63 Walmart 1 tube — — FDA listed —
Equate Pro-Advanced TP Equate Pro-Advanced TP .16 g/100g 79903-0281-70 Walmart 1 tube — — FDA listed —
Crest Pro-Health Maximum Cavity Protection 1.5 mg/g 84126-0608-03 The 3 tubes — — FDA listed —
Crest Pro-Health Gum Rescue Pro Soothing Clean 1.5 mg/g 84126-0609-46 The 1 tube — — FDA listed —
KIDS Crest Advanced Sugar and Bacteria Shield 1.5 mg/g 84126-0612-03 The 1 cello — — FDA listed —
Crest Pro-Health Gum Detoxify Plus 1.5 mg/g 84126-0613-45 The 1 tube — — FDA listed —
Crest Pro Health Peppermint Frost 1.5 mg/g 84126-0618-43 The 1 tube — — FDA listed —
Crest Snowberry 1.5 mg/g 84126-0619-41 The 1 tube — — FDA listed —
Crest Pro-Health Gum Recession 1.5 mg/g 84126-0623-06 The 6 tubes — — FDA listed —
Crest Pro-Health Advanced Max Cavity and Erosion Prevention 1.5 mg/g 84126-0624-02 The 1 cello — — FDA listed —
Crest Clean Breath Spearmint 1.5 mg/g 84126-0627-03 The 1 cello — — FDA listed —
Crest Pro-Health Advanced Bacteria Protection 1.4 mg/g 84126-0638-05 The 2 tubes — — FDA listed —
Crest Clean Breath Peppermint 1.5 mg/g 84126-0641-25 The 1 tube — — FDA listed —
Crest Clean Breath Spearmint 1.5 mg/g 84126-0642-03 The 1 cello — — FDA listed —
Crest Clean Breath Smooth Mint 1.5 mg/g 84126-0643-03 The 3 tubes — — FDA listed —
Crest Pro Health Advanced Protection 1.4 mg/g 84126-0657-58 The 1 tube — — FDA listed —
Livfresh Gum Protect 4.54 mg/g 87398-0001-01 Livionex 1 tube — — 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
Oct 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
51206-0313-01 You're viewing this 1 TUBE in 1 CARTON (51206-313-01) / 133 g in 1 TUBE 2024-10-21 Active
51206-0313-02 12 CARTON in 1 PACKAGE, COMBINATION (51206-313-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 2024-10-21 Active

Pack size FAQ

What quantity is in NDC 51206-0313-01?
NDC 51206-0313-01 is listed by the FDA — 1 tube in 1 carton / 133 g in 1 tube.
What NDC number is used to bill for this package of Opal by Opalescence Complete 1.1 mg/g Gel, Dentifrice?
Bill NDC 51206-0313-01 — the 11-digit billing format is 51206031301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 51206-313-01, 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: 51206-0313-01, written without dashes as 51206031301. 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 51206-0313-01, the first segment (51206) is the labeler code FDA assigned to Ultradent Products, Inc.; the middle segment (0313) 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 it is currently marketed — but Ultradent Products, Inc. has reported a marketing end date of 2027-08-14, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (51206-0313-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Ultradent Products, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
⚠️ Warnings
⚠️ Warnings 31 words ▾

Keep out of reach of children under 6 years of age. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51206-0312-02 · Ultradent 51206-0314-01 · Ultradent →
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.