HomeNDC LookupIngredientsStannous Fluoride › 00135-0573-02
Sensodyne Complete Protection stannous fluoride 1.1 mg/g Paste, 1 tube — NDC 00135-0573-02 package photo

Sensodyne Complete Protection stannous fluoride 1.1 mg/g Paste, 1 tube

by Haleon US Holdings LLC · 1 TUBE in 1 CARTON (0135-0573-02) / 96.4 g in 1 TUBE
NDC 00135-0573-02
🏷️ FDA NDC (as labeled) 0135-0573-02 billing pads the labeler segment with a zero
This package
Contains1 tube Pack sizes2 compare ↓
Also comes in: 23 g 00135-0573-03
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0135-0573-02
Product NDC 0135-0573
11-digit billing NDC 00135057302
RxCUI 416784
UNII 3FTR44B32Q
Application # M022
SPL Set ID e3cc3146-8aed-4f6b-a252-e379418c2b8d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-07-14
Route DENTAL
Dosage form PASTE
Substance STANNOUS FLUORIDE
Why two NDCs? The FDA registers this code as 0135-0573-02 — 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 → 00135-0573-02. 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
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 marketedJul 2014
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

🧪 What is this product?

Sensodyne Complete Protection is a toothpaste containing stannous fluoride, marketed as an over-the-counter monograph product. Stannous fluoride is commonly used in dental care products to help strengthen tooth enamel and reduce sensitivity. This paste is applied topically to the teeth during brushing as part of regular oral hygiene.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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: 23 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/gthis 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/g 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
Colgate Sensitive ProRelief Whitening 1.1 mg/g 35000-0285-47 Colgate-Palmolive 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

🏛️
2014
On the market since
Jul 2014
📍
2026
Currently FDA-listed
12 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 Sensodyne Complete Protection (this brand).

Top reported reactions

Oral Discomfort10
Dyspnoea6
Oral Pain6
Glossodynia5
Oral Mucosal Exfoliation5
Stomatitis5
Cough4

Age at onset

Child1
Adult1
Elderly1

Reporter sex

68 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization18
Death6
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 13 1
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
00135-0573-02 You're viewing this 1 TUBE in 1 CARTON (0135-0573-02) / 96.4 g in 1 TUBE 2014-07-14 Active
00135-0573-03 1 TUBE in 1 CARTON (0135-0573-03) / 23 g in 1 TUBE 2014-07-14 Active

Pack size FAQ

What quantity is in NDC 00135-0573-02?
NDC 00135-0573-02 contains 1 tube — 1 tube in 1 carton / 96.4 g in 1 tube.
What NDC number is used to bill for this package of Sensodyne Complete Protection stannous fluoride 1.1 mg/g Paste?
Bill NDC 00135-0573-02 — the 11-digit billing format is 00135057302. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 0135-0573-02, 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: 00135-0573-02, written without dashes as 00135057302. 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 00135-0573-02, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0573) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (00135-0573-03). 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?
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 47 words

Uses • aids in the prevention of dental cavities. • helps prevent gingivitis, an early form of gum disease. • helps interfere with harmful effects of plaque associated with gingivitis. • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

⏱️ Dosage and Administration 85 words

Directions • adults and children 12 years of age and older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush. • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • children under 12 years of age: Consult a dentist or doctor.

⚠️ Warnings 109 words

Warnings Stop use and ask a dentist if: • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use. • gingivitis, bleeding, or redness persists for more than 2 weeks. • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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

🧪 Active Ingredient 8 words

Active ingredient Stannous fluoride 0.454% (0.15%w/v fluoride ion)

🧪 Inactive Ingredients 43 words

Inactive ingredients (Mint) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

Inactive ingredients (Extra Fresh) glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

🎯 Purpose 4 words

Purposes Anticavity, Antigingivitis, Antihypersensitivity

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.