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COLGATE Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice — NDC 35000-0913-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

COLGATE Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice — NDC 35000-913-01 (Billing 35000-0913-01)

by Colgate-Palmolive Company · 1 TUBE in 1 CARTON / 28 g in 1 TUBE

This is a package of COLGATE Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice from Colgate-Palmolive Company, marketed since Nov 2005 and currently FDA-listed. It is the main listing for this product, which comes in 17 package sizes.

NDC 35000-0913-01
🏷️ FDA NDC (as labeled) 35000-913-01 billing pads the product segment with a zero
This package
Contains28 g in 1 tube Pack sizes17 compare ↓
Main listing for product 35000-913 · Also comes in: 36.8 g 35000-913-33 130 g 35000-913-46 226 g 35000-913-48 70 g 35000-913-58 181 g 35000-913-64 113 g 35000-913-69 79 g 35000-913-79 232 g 35000-913-82 141 g 35000-913-92 170 g 35000-913-62 2 tubes 35000-913-34 3 tubes 35000-913-30 4.25 g 35000-913-04 24 g 35000-913-20 99 g 35000-913-93 170 g 35000-913-60
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 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

NDC database record

One package, one record: these facts belong to NDC 35000-913-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
35000 labeler · 913 product · 01 package
Package marketed since
Nov 5, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 3500091301 3
FDA record last changed
Aug 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 35000-913-01
Product NDC 35000-913
11-digit billing NDC 35000091301
RxCUI 545626
UNII C810JCZ56Q
Application # M021
SPL Set ID 730f40f6-6ac6-49bd-888b-c0b5818a03c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-11-05
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM MONOFLUOROPHOSPHATE
Quick answers
  • RxCUI (RxNorm): 545626
Why two NDCs? The FDA registers this code as 35000-913-01 — 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 → 35000-0913-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Caries prophylactic agents class.

Drug family (ATC) Caries prophylactic agents, Fluoride
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Colgate Great Regular Flavor is a fluoride toothpaste sold over the counter as an OTC monograph product. It contains sodium monofluorophosphate, a fluoride compound typically used in toothpastes to help strengthen tooth enamel and reduce cavities. This paste is applied to teeth by brushing and is a common ingredient in many dental care products designed for routine oral hygiene.

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.

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: 36.8 g 130 g 226 g 70 g 181 g 113 g 79 g 232 g 141 g 170 g 2 tubes 3 tubes 4.25 g 24 g 99 g 170 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
35000-0913-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2005-11-05 — Active
35000-0913-04 35000-913-04 4.25 g in 1 POUCH 2005-11-05 — Active
35000-0913-20 35000-913-20 24 g in 1 TUBE 2005-11-05 — Active
35000-0913-33 35000-913-33 1 TUBE in 1 CARTON / 36.8 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-46 35000-913-46 1 TUBE in 1 CARTON / 130 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-48 35000-913-48 1 TUBE in 1 CARTON / 226 g in 1 TUBE 2005-11-05 — Active
35000-0913-58 35000-913-58 1 TUBE in 1 CARTON / 70 g in 1 TUBE 2005-11-05 — Active
35000-0913-60 35000-913-60 170 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-64 35000-913-64 1 TUBE in 1 CARTON / 181 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-69 35000-913-69 1 TUBE in 1 CARTON / 113 g in 1 TUBE 2005-11-05 — Active
35000-0913-79 35000-913-79 1 TUBE in 1 CARTON / 79 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-82 35000-913-82 1 TUBE in 1 CARTON / 232 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-92 35000-913-92 1 TUBE in 1 CARTON / 141 g in 1 TUBE 2005-11-05 — Active
35000-0913-93 35000-913-93 99 g in 1 TUBE 2005-11-05 — Discontinued by firm
35000-0913-30 35000-913-30 3 TUBE in 1 CARTON / 170 g in 1 TUBE 2005-11-05 — Active
35000-0913-34 35000-913-34 2 TUBE in 1 CARTON / 170 g in 1 TUBE 2024-01-01 — Active
35000-0913-62 35000-913-62 1 TUBE in 1 CARTON / 170 g in 1 TUBE 2026-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 28 g in 1 tube.
What NDC number is used to bill for this package of COLGATE Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
biotene 1.4 mg/g 00135-0577-01 Haleon 1 tube — — FDA listed —
Whitening .14 g/100g 11673-0385-09 Target 2 tubes — — FDA listed —
Kids Strawberry FTP .13 g/100g 11673-0441-01 Target 1 tube — — FDA listed —
Simple Truth Kids Flouride .76 g/100g 30142-0146-79 Kroger 119 g — — FDA listed —
Natural Adult Fluoride .76 g/100g 30142-0223-39 Kroger 1 tube — — FDA listed —
Colgate Revitalizing White 1 mg/g 35000-0017-46 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Cavity Protection Great Regular Flavor 1 mg/g 35000-0060-48 Colgate-Palmolive 1 tube — — FDA listed —
Hello Whipped Peppermint Stick Flavor 1.1 mg/g 35000-0512-10 Colgate-Palmolive 1 tube — — FDA listed —
Hello Whipped Mellow Mint Dream Flavor 1.1 mg/g 35000-0513-10 Colgate-Palmolive 1 tube — — FDA listed —
Hello Activated Charcoal 1.1 mg/g 35000-0678-10 Colgate-Palmolive 1 tube — — Discontinued —
Hello Naturally Whitening 1.1 mg/g 35000-0682-10 COLGATE 1 tube — — FDA listed —
Colgate Optic White Pro Series Stain Prevention 1.1 mg/g 35000-0747-16 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Stain Prevention 1 mg/g 35000-0893-43 Colgate-Palmolive 1 tube — — Discontinued —
COLGATE Great Regular Flavor 1 mg/gthis 35000-0913-01 Colgate-Palmolive 1 tube — — FDA listed —
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint 1 mg/g 35000-0916-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sparkling White Mint Zing 1 mg/g 35000-0919-46 Colgate-Palmolive 1 tube — — Discontinued —
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 35000-0959-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Platinum Stain-Less 1 mg/g 35000-0973-32 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Essentials 1 mg/g 35000-0974-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Advanced Icy Fresh 1 mg/g 35000-0977-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Advanced Sparkling White 1 mg/g 35000-0978-14 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Renewal High Impact White 1 mg/g 35000-0982-15 Colgate-Palmolive 1 tube — — Discontinued —
MediChoice Fluoride 7.6 mg/g 39892-0602-01 O&M 17 g — — FDA listed —
Natures Promise Childrens Fluoride Strawberry .13 g/100g 41520-0724-29 Foodhold 119 g — — FDA listed —
Charm Tex FLUORIDE .1 g/100g 42086-0051-01 Jiangsu 720 tubes — — FDA listed —
United Dental Kit 42509-0134-01 Wessco 1 kit — — FDA listed —
Colgate Anticavity 7.6 mg/g 42555-0060-45 Colgate-Palmolive 10 g — — FDA listed —
365 Everyday Value Cavity Fighting and Whitening .13 g/100g 42681-5002-09 Whole 1 tube — — Discontinued —
365 Everyday Value Kids Flouride .13 g/100g 42681-5276-09 Whole 119 g — — FDA listed —
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar 1.4 mg/g 51009-0202-04 Tom's 1 tube — — FDA listed —
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar 1.4 mg/g 51009-0203-04 Tom's 1 tube — — FDA listed —
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection 1.4 mg/g 51009-0205-47 Tom's 1 tube — — Discontinued —
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection 1.4 mg/g 51009-0206-47 Tom's 1 tube — — Discontinued —
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR 1.4 mg/g 51009-0219-04 Tom's 1 tube — — FDA listed —
Toms Kids Watermelon Wiggle 1 mg/g 51009-0854-42 Tom's 119 g — — Discontinued —
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0857-69 Tom's 1 tube — — FDA listed —
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0858-69 Tom's 1 tube — — FDA listed —
Toms Of Maine Wicked Fresh Cool Peppermint 1 mg/g 51009-0859-07 Tom's 1 tube — — FDA listed —
Toms Of Maine Wicked Fresh Spearmint Ice 1 mg/g 51009-0860-07 Tom's 1 tube — — FDA listed —
Toms Of Maine Whole Care Wintermint 1 mg/g 51009-0902-40 Tom's 1 tube — — FDA listed —
Toms Of Maine Kids Silly Strawberry 1 mg/g 51009-0910-10 Tom's 1 tube — — Discontinued —
Toms Of Maine Kids Outrageous Orange Mango 1 mg/g 51009-0911-51 Tom's 144 g — — FDA listed —
Toms Of Maine Wicked Cool Mild Mint 1 mg/g 51009-0912-51 Tom's 144 g — — FDA listed —
Freshmint Anticavity Fluoride 7.6 mg/g 51824-0067-01 New 17 g — — FDA listed —
Anti Cavity Fluoride .76 g/100g 52000-0107-01 Universal 181 g — — FDA listed —
Advanced Whitening Anti Cavity Fluoride .76 g/100g 52000-0108-01 Universal 181 g — — FDA listed —
Universal Anti-Cavity Fluoride .76 g/100g 52000-0111-01 Universal 181 g — — FDA listed —
Universal Advanced Whitening Anti-Cavity Fluoride .76 g/100g 52000-0112-01 Universal 181 g — — FDA listed —
Medpride 7.6 mg/g 52410-9005-03 Shield 42.5 g — — FDA listed —
PERIOSCIENCES HYDRATING AO Pro 1.3 mg/mL 53238-0003-90 PERIOSCIENCES 1 tube — — FDA listed —
Nature Mint Anticavity 7.6 mg/g 53247-0129-01 Bob 7.94 g — — FDA listed —
Nature Mint Anticavity 7.6 mg/g 53247-0144-01 Bob 7.94 g — — Discontinued —
SparkleFresh Flouride Toothpaste 1 mg/g 53329-0083-21 Medline 42.5 g — — FDA listed —
Rexall Travel Toothbrush and Tooth-paste 55910-0087-01 Old 1 kit — — FDA listed —
Colgate Anticavity Kit 7.6 mg/g 56153-0001-05 Ming 1 tube — — FDA listed —
Colgate Anticavity Kit 7.6 mg/g 56153-0002-05 Ming 1 tube — — FDA listed —
First Class Kit 7.6 mg/g 58701-0001-10 American 1 tube — — FDA listed —
Business Class Kit 7.6 mg/g 58701-0002-10 American 1 tube — — FDA listed —
United Airlines Business Class Kit 7.6 mg/g 58733-0001-10 United 1 tube — — FDA listed —
smart way MINT cavity protection .13 g/100g 59450-0010-01 The 1 tube — — FDA listed —
AP-24 Whitening 7.6 mg/g 62839-1155-01 NSE 110 g — — FDA listed —
COLGATE Great Regular Flavor 1 mg/g 65954-0060-01 Mission 1 tube — — FDA listed —
Colgate ULTRA BRITE Baking Soda and Peroxide Whitening 1.1 mg/g 65954-0063-60 Mission 1 tube — — FDA listed —
Colgate Sparkling White Mint Zing 1 mg/g 65954-0068-48 Mission 1 tube — — FDA listed —
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 65954-0765-48 Mission 1 tube — — FDA listed —
Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint 1 mg/g 65954-0768-35 Mission 3 tubes — — FDA listed —
Colgate Optic White Platinum Stain-Less 1 mg/g 65954-0785-32 Mission 1 tube — — FDA listed —
Colgate Essentials 1 mg/g 65954-0786-46 Mission 1 tube — — FDA listed —
Colgate Great Regular Flavor 1 mg/g 67751-0118-01 Navajo 1 tube — — FDA listed —
Morning Fresh 76 mg/g 67777-0175-11 Dynarex 1 tube — — FDA listed —
Sodium Monofluorophosphate 760 mg/g 67777-0181-02 Dynarex 144 tubes — — FDA listed —
Morning Fresh Mint Toothpaste, with Fluoride 1.3 mg/mL 67777-0190-03 Dynarex 144 tubes — — FDA listed —
Fluoride .76 g/g 68599-9571-01 McKesson 1 g — — FDA listed —
Murchison Hume Dental Kit 69491-0034-01 Buzz 1 kit — — FDA listed —
Ipana Wintergreen Fluoride .1 g/100g 69510-0010-19 Maxill 1 tube — — FDA listed —
Ipana Bucky Beaver Bubble Gum Childrens Fluoride .1 g/100g 69510-0020-19 Maxill 1 tube — — FDA listed —
Listerine Essential Care 1.3 mg/g 69968-0701-04 Kenvue 1 tube — — FDA listed —
Brush Buddies Value 2 pack Whitening .76 g/100g 70108-0030-01 Ashtel 2 tubes — — FDA listed —
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE .15 g/100g 70108-0185-01 Ashtel 2 tubes — — FDA listed —
Charm Tex FLUORIDE .1 g/100g 71035-0001-01 Yangzhou 720 tubes — — FDA listed —
dentalux ANTI-CAVITY FLUORIDE .13 g/100g 71141-0186-10 Lidl 1 tube — — FDA listed —
Orazen .1 g/100g 71927-0102-01 Orazen 1 tube — — FDA listed —
Colgate 5g Toothbrush Kit 72845-0000-00 Wuhan 1 kit — — FDA listed —
Colgate Anticavity 73234-0040-00 MING 1 kit — — FDA listed —
Cloveden Tooth .76 g/100g 73242-1112-02 DONG 1 tube — — FDA listed —
White Glo Micellar 73656-0003-00 WHITE 1 kit — — FDA listed —
White Glo Bio-Enzyme 73656-0005-00 WHITE 1 kit — — FDA listed —
White Glo Professional Choice 73656-0007-00 WHITE 1 kit — — FDA listed —
White Glo Charcoal 73656-0009-00 WHITE 1 kit — — FDA listed —
White Glo Maximum White Charcoal 73656-0013-00 WHITE 1 kit — — FDA listed —
White Glo Instant White 73656-0015-00 WHITE 1 kit — — FDA listed —
White Glo Mouthwash Protection 73656-0017-00 WHITE 1 kit — — FDA listed —
White Glo Activated Charcoal Twin Pack 73656-0020-00 WHITE 1 kit — — FDA listed —
White Glo Professional Choice Twin Pack 73656-0024-00 WHITE 1 kit — — FDA listed —
White Glo Advantage Anticavity Fluoride Purple 7.6 mg/g 73656-0026-00 WHITE 1 tube — — FDA listed —
White Glo Advantage Anticavity Professional Whitening 7.6 mg/g 73656-0027-00 WHITE 1 tube — — FDA listed —
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and Toothbrush 73656-0028-00 WHITE 1 kit — — FDA listed —
White Glo Coffee and Tea Stain Remover Fluoride Anticavity 73656-0030-00 WHITE 1 kit — — FDA listed —
Optimax Anticavity Fluoride Watermelon 7.6 mg/g 73656-0032-00 WHITE 1 tube — — FDA listed —
Optimax Anticavity Fluoride Cotton Candy 7.6 mg/g 73656-0033-00 WHITE 1 tube — — FDA listed —
Optimax Purple Anticavity Fluoride 73656-0034-00 WHITE 1 kit — — FDA listed —
Optimax Professional Whitening Anticavity Fluoride 73656-0036-00 WHITE 1 kit — — FDA listed —
Optimax Professional Whitening Anticavity Fluoride 73656-0038-00 WHITE 1 kit — — FDA listed —
Optimax Purple Anticavity Fluoride 73656-0039-00 WHITE 1 kit — — FDA listed —
White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity 73656-0041-00 White 1 kit — — FDA listed —
White Glo Coffee and Tea Stain Remover Fluoride Anticavity 73656-0042-00 White 1 kit — — FDA listed —
White Glo Professional Choice Fluoride Anticavity 7.6 mg/g 73656-0043-00 White 2 tubes — — FDA listed —
White Glo Mouthwash Protect Fluoride Anticavity 73656-0044-00 White 1 kit — — FDA listed —
White Glo Extreme White Whitening 7.6 mg/g 73656-0046-00 White 2 tubes — — FDA listed —
White Glo Purple Color Corrector Fluoride Anticavity 7.6 mg/g 73656-0047-00 White 2 tubes — — FDA listed —
Optimax Anticavity Fluoride Bubblegum 7.6 mg/g 73656-0048-00 White 1 tube — — FDA listed —
Optimax Anticavity Fluoride Raspberry 7.6 mg/g 73656-0049-00 White 1 tube — — FDA listed —
Freshen Up .76 g/100g 77782-0005-20 MKJ 2 bottles — — FDA listed —
Colgate Anticavity 79940-0010-00 FORMIA 1 kit — — FDA listed —
Colgate Anticavity 79940-0012-00 FORMIA 1 kit — — FDA listed —
Colgate Anticavity 79940-0013-00 FORMIA 1 kit — — FDA listed —
Coffe Tea Stain Remover Tooth .76 g/100g 82168-0001-01 Guangzhou 150 g — — FDA listed —
Instant Whitening .76 g/100g 82168-0002-01 Guangzhou 150 g — — FDA listed —
Professional Choice .76 g/100g 82168-0003-01 Guangzhou 150 g — — FDA listed —
Professional whitening tooth .76 g/100g 82168-0004-01 Guangzhou 100 g — — FDA listed —
purple tooth .76 g/100g 82168-0005-01 Guangzhou 100 g — — FDA listed —
Zohar Fluoride Anti Cavity Coolmint Flavour 7.6 mg/g 84045-0004-00 ZOHAR 1 tube — — Discontinued —
Zohar Fluoride Anti-Cavity Regular Mint Flavour 7.6 mg/g 84045-0005-00 ZOHAR 1 tube — — Discontinued —
Zohar Fluoride Anti Cavity Fresh Mint Flavor 7.6 mg/g 84045-0006-00 ZOHAR 1 tube — — Discontinued —
DeCure 7.6 mg/g 84132-0100-10 Scope 10 g — — FDA listed —
Carekon Anti-Cavity Fluoride .76 g/100g 84345-0086-01 Hunan 1 tube — — FDA listed —
Nature Mint Anti cavity Fluoride .1 g/100g 85891-0009-01 SPARROW 720 tubes — — Discontinued —
Fluoride Anticavity,Toothpaste .76 g 87576-0332-02 Shulisa 1 tube — — FDA listed —
Colgate Optic White Renewal Brilliant Shine 1 mg/g 35000-0955-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Baking Soda And Peroxide Whitening Oxygen Bubbles Frosty Mint 1 mg/g 35000-0960-60 Colgate-Palmolive 1 tube — — FDA listed —
TP OW Pro Series Stain Prevention 1 mg/g 35000-0939-62 Colgate-Palmolive 2 tubes — — FDA listed —
TP OW Pro Series Vividly Fresh 1 mg/g 35000-0940-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Pro Series Express White 1 mg/g 35000-0794-62 Colgate-Palmolive 2 tubes — — FDA listed —
Optic White Pro Series Vibrant Clean 1 mg/g 35000-0795-63 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Advanced Stain Prevention 1 mg/g 35000-0075-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Platinum High Impact White 1 mg/g 35000-0066-41 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Platinum Stain Prevention Sparkling Mint 1 mg/g 35000-0074-41 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Renewal High Impact White 1 mg/g 35000-0957-62 Colgate-Palmolive 2 tubes — — 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

🏛️
2005
On the market since
Nov 2005
📍
2026
Currently FDA-listed
21 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.

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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • 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 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 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 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.

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

The official label also statesDicalcium Phosphate Dihydrate, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Tetrasodium Pyrophosphate, Sodium Saccharin.

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.

Manufacturer & labeler

LabelerColgate-Palmolive Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code35000
First marketedNov 2005
Product typeHuman Otc Drug
Portfolio190 products on file

More NDCs from Colgate-Palmolive Company labeler code 35000

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.

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Use helps protect against cavities

⏱️ Dosage and Administration 60 words ▾

Directions adults and children 2 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 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

⚠️ Warnings 33 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium Monofluorophosphate 0.76% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients Dicalcium Phosphate Dihydrate, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Tetrasodium Pyrophosphate, Sodium Saccharin.

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 32 words ▾

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

📄 Questions or Comments 2 words ▾

Questions? 1-800-468-6502

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton Colgate ® Anticavity Fluoride Toothpaste NET WT

6.0OZ (170 g) ADA Accepted American Dental Association ® Cavity Protection Strengthens Teeth with Active Fluoride Great Regular Flavor PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

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

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 Great Regular Flavor (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

8 reports
Male · 75%
Female · 25%

Serious outcomes

Hospitalization3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2 0
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Colgate-Palmolive 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 16 other package presentations of this same product, including 1 tube (35000-0913-33), 1 tube (35000-0913-46), 1 tube (35000-0913-48). 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?
Colgate-Palmolive 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.
← 35000-0908-81 · Colgate-Palmolive 35000-0915-46 · Colgate-Palmolive →
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.