NDC 84126-0611-31 — Crest 3D White Deep Stain Remover Ultra White

🆔 Identity & classification

FDA NDC (as labeled) 84126-611-31

Product NDC 84126-611

11-digit billing NDC 84126061131

RxCUI 1038995

UNII C810JCZ56Q

Application # M021

SPL Set ID 2f24a9eb-7a89-30e1-e063-6394a90a032b

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-01-07

Route ORAL

Dosage form PASTE, DENTIFRICE

Substance SODIUM MONOFLUOROPHOSPHATE

Why two NDCs? The FDA registers this code as 84126-611-31 — 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 → 84126-0611-31. 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

LabelerThe Procter & Gamble Manufacturing Company

FDA applicationM021 (OTC MONOGRAPH DRUG)

Labeler code84126

First marketedJan 2023

Product typeHuman Otc Drug

Portfolio846 products on file

🔎 All NDCs from The Procter & Gamble Manufacturing Compa...

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 a toothpaste marketed as an over-the-counter monograph drug under FDA's established rules for oral dentifrices. The active ingredient is sodium monofluorophosphate, a fluorine compound typically used in toothpastes to help strengthen tooth enamel and reduce cavity formation. The product is formulated as a paste applied by toothbrush and is intended for regular oral hygiene use.

Patient education

📘 MedlinePlus patient leaflet ↗

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 white

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 5C69YCD2YJ
Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
UNII 5OCF3O11KX
A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
UNII Y6O7T4G8P9
Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
UNII V8A1AW0880
Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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 H5WVD9LZUD
A mineral salt used in medicines as a buffer to help maintain proper acidity levels and as a texturing agent in solid dosage forms. It helps stabilize the medicine and improve its shelf life.
UNII P1BM4ZH95L
A salt derived from phosphoric acid, sodium polymetaphosphate acts as a sequestrant and buffering agent in medicines. It helps maintain stability and control acidity in liquid formulations.
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 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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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.

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

The official label also stateswater, sorbitol, hydrated silica, sodium hexametaphosphate, disodium pyrophosphate, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, sodium saccharin, cocamidopropyl betaine, phosphoric acid, sucralose, mica, titanium dioxide

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 system	Per g	Per 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: 59 g 24 g 2 tubes 2 tubes 4 tubes

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Colgate Optic White Pro Series Enamel Renewal Soothing Mint 1.5 mg/g 35000-0791-62	Colgate-Palmolive	2 tubes	—	—	FDA listed	—
Colgate Optic White Pro Series High Impact White 1.5 mg/g 35000-0792-63	Colgate-Palmolive	1 tube	—	—	FDA listed	—
Colgate Optic White Advanced Enamel Strength 1.5 mg/g 35000-0921-32	Colgate-Palmolive	1 tube	—	—	FDA listed	—
Colgate Optic White Advanced Oxygenating White 1.5 mg/g 35000-0933-32	Colgate-Palmolive	1 tube	—	—	FDA listed	—
Colgate Optic White Advanced Vibrant Clean 1.5 mg/g 35000-0979-32	Colgate-Palmolive	1 tube	—	—	Discontinued	—
Colgate Optic White Pro Series Hi White 1.5 mg/g 65954-0841-63	Mission	1 tube	—	—	FDA listed	—
Colgate Optic White Pro Series 11.4 mg/g 65954-0845-62	Mission	2 tubes	—	—	FDA listed	—
Crest 3D White Advanced 1.7 mg/g 69423-0752-30	The	1 tube	—	—	FDA listed	—
Crest 3D White Brilliance Pro Ultra White 1.7 mg/g 69423-0760-30	The	1 tube	—	—	FDA listed	—
ARC 2 in 1 Whitening and Anticavity 1.7 mg/g 69423-0837-30	The	1 tube	—	—	FDA listed	—
Crest 3D White Brilliance Advanced Whitening Fresh Mint 1.7 mg/g 69423-0959-04	The	1 cello	—	—	FDA listed	—
Hapee Explosive Menthol Red 150 .15 g/100g 1480003401156	LAMOIYAN	1 tube	—	—	FDA listed	—
Hapee Fresh And Cool White 150 .15 g/100g 1480003401136	LAMOIYAN	1 tube	—	—	FDA listed	—
Hapee Fresh And Cool White 100 .15 g/100g 1480003401135	LAMOIYAN	1 tube	—	—	FDA listed	—
Hapee Gumtect Gum Care .15 g/100g 1480003401325	LAMOIYAN	1 tube	—	—	FDA listed	—
Hapee Fresh Green Outburst 100 .15 g/100g 1480003401165	LAMOIYAN	1 tube	—	—	FDA listed	—
Hapee Fresh Green Outburst 150 .15 g/100g 1480003401166	LAMOIYAN	1 tube	—	—	FDA listed	—
Hapee Outrageous Blue Chill 150 .15 g/100g 1480003401336	LAMOIYAN	1 tube	—	—	FDA listed	—
Crest 3D White Deep Stain Remover Dazzling Mint 2 mg/g 84126-0610-21	The	1 tube	—	—	FDA listed	—
Crest 3D White Deep Stain Remover Ultra White 2 mg/gthis 84126-0611-31	The	1 tube	—	—	FDA listed	—
Crest 3D White Brilliance Pro Ultra White 1.7 mg/g 84126-0616-38	The	1 tube	—	—	FDA listed	—
Crest 3D White Deep Stain Remover Brilliant White 2 mg/g 84126-0626-03	The	2 tubes	—	—	FDA listed	—
Crest 3D White Deep Stain Remover Enamel Strength 2 mg/g 84126-0644-21	The	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

🏛️

2023

On the market since

Jan 2023

📍

2026

Currently FDA-listed

3 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 Crest 3D White Deep Stain Remover Ultra White (this brand).

Top reported reactions

Gingivitis4

Tooth Loss4

Anaphylactic Reaction3

Dyspnoea3

Mouth Swelling3

Sensitivity Of Teeth3

Tooth Fracture3

Age at onset

Adult4

Reporter sex

Male · 44%

Female · 56%

Serious outcomes

Hospitalization5

Disabling2

Life-threatening1

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
84126-0611-02	2 TUBE in 1 CARTON (84126-611-02) / 59 g in 1 TUBE	2026-01-06	Active
84126-0611-03	2 TUBE in 1 CARTON (84126-611-03) / 87 g in 1 TUBE	2025-05-01	Active
84126-0611-04	4 TUBE in 1 CARTON (84126-611-04) / 59 g in 1 TUBE	2023-01-07	Active
84126-0611-21	1 TUBE in 1 CARTON (84126-611-21) / 59 g in 1 TUBE	2023-01-07	Active
84126-0611-31 You're viewing this	1 TUBE in 1 CARTON (84126-611-31) / 87 g in 1 TUBE	2023-01-07	Active
84126-0611-85	1 TUBE in 1 CARTON (84126-611-85) / 24 g in 1 TUBE	2026-07-01	Active

Pack size FAQ

What quantity is in NDC 84126-0611-31?

NDC 84126-0611-31 is listed by the FDA — 1 tube in 1 carton / 87 g in 1 tube.

What NDC number is used to bill for this package of Crest 3D White Deep Stain Remover Ultra White Sodium monofluorophosphate 2 mg/g Paste, Dentifrice?

Bill NDC 84126-0611-31 — the 11-digit billing format is 84126061131. 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 84126-611-31, 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: 84126-0611-31, written without dashes as 84126061131. 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 84126-0611-31, the first segment (84126) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0611) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) 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 The Procter & Gamble Manufacturing Company. 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 5 other package presentations of this same product, including 1 tube (84126-0611-21), 1 tube (84126-0611-85), 2 tubes (84126-0611-02). 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?

The Procter & Gamble Manufacturing Company 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 5 words ▾

Use helps protect against cavities

⏱️ Dosage and Administration 41 words ▾

Directions adults and children 6 yrs. & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. • do not swallow • children under 6 yrs.: ask a dentist

🧪 Active Ingredient 9 words ▾

Drug Facts Sodium monofluorophosphate 1.14% (0.20% w/v fluoride ion)

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients water, sorbitol, hydrated silica, sodium hexametaphosphate, disodium pyrophosphate, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, sodium saccharin, cocamidopropyl betaine, phosphoric acid, sucralose, mica, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Anticavity toothpaste

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Sodium Monofluorophosphate NDCsSame ingredient 🏭 All The labeler NDCsLabeler code 84126 📖 Read the Sodium Monofluorophosphate drug informationUses, warnings & side effects