NDC 65954-0845-63 — COLGATE OPTIC WHITE PRO SERIES SODIUM

🆔 Identity & classification

FDA NDC (as labeled) 65954-845-63

Product NDC 65954-845

11-digit billing NDC 65954084563

RxCUI 1038995

UNII C810JCZ56Q

UPC 0827854028468

Application # M022

SPL Set ID a48e83ae-a02a-4a6d-a601-7acaba3bbbc9

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-11-24

Route DENTAL

Dosage form PASTE, DENTIFRICE

Substance SODIUM MONOFLUOROPHOSPHATE

Why two NDCs? The FDA registers this code as 65954-845-63 — 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 → 65954-0845-63. 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

LabelerMission Hills, S.A. de C.V.

FDA applicationM022 (OTC MONOGRAPH DRUG)

Labeler code65954

First marketedNov 2025

Product typeHuman Otc Drug

Portfolio15 products on file

🔎 All NDCs from Mission Hills, S.A. de C.V.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter toothpaste containing sodium monofluorophosphate, a fluoride compound. The product is a dental paste applied by brushing teeth. Sodium monofluorophosphate is typically used in toothpastes to help strengthen tooth enamel and reduce the risk of cavities. This product is marketed under the FDA's over-the-counter monograph rules for anticavity toothpastes.

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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.

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 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: 2 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/gthis 65954-0845-63	Mission	1 tube	—	—	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/g 84126-0611-02	The	2 tubes	—	—	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

🏛️

2025

On the market since

Nov 2025

📍

2026

Currently FDA-listed

1 year 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 COLGATE OPTIC WHITE PRO SERIES (this brand).

Top reported reactions

Pelvic Fracture2

Abdominal Discomfort1

Abdominal Pain Upper1

Bone Metabolism Disorder1

Burning Sensation1

Cardiac Disorder1

Chest Pain1

Age at onset

Adult1

Reporter sex

Male · 78%

Female · 22%

Serious outcomes

Hospitalization3

Life-threatening1

Disabling1

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
65954-0845-62	2 TUBE in 1 CARTON (65954-845-62) / 85 g in 1 TUBE	2025-11-24	Active
65954-0845-63 You're viewing this	1 TUBE in 1 CARTON (65954-845-63) / 85 g in 1 TUBE	2025-11-24	Active

Pack size FAQ

What quantity is in NDC 65954-0845-63?

NDC 65954-0845-63 is listed by the FDA — 1 tube in 1 carton / 85 g in 1 tube.

What NDC number is used to bill for this package of COLGATE OPTIC WHITE PRO SERIES SODIUM MONOFLUOROPHOSPHATE 11.4 mg/g Paste, Dentifrice?

Bill NDC 65954-0845-63 — the 11-digit billing format is 65954084563. 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	— Not published for this NDC No photo available yet for this listing.
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 65954-845-63, 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: 65954-0845-63, written without dashes as 65954084563. 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 65954-0845-63, the first segment (65954) is the labeler code FDA assigned to Mission Hills, S.A. de C.V.; the middle segment (0845) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (63) 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 Mission Hills, S.A. de C.V.. 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 2 tubes (65954-0845-62). 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?

Mission Hills, S.A. de C.V. 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 5 words ▾

Use helps protect against cavities

⏱️ Dosage and Administration 65 words ▾

Directions adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 6 years do not use unless directed by a dentist or physician

⚠️ Warnings 32 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium Monofluorophosphate 1.14% (0.18% w/v fluoride ion)

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Propylene Glycol, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Flavor, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

🎯 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 ↗

🔗 Related NDC lookups

🧪 All Sodium Monofluorophosphate NDCsSame ingredient 🏭 All Mission labeler NDCsLabeler code 65954 📖 Read the Sodium Monofluorophosphate drug informationUses, warnings & side effects