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Topco Associates LLC Maximum Strength Fluoride .15 g/100g; 5 g/100g Paste, Dentifrice — NDC 36800-481-49 (Billing 36800-0481-49)

by Topco Associates LLC · 1 TUBE in 1 CARTON / 113 g in 1 TUBE

This is a package of Topco Associates LLC Maximum Strength Fluoride .15 g/100g; 5 g/100g Paste, Dentifrice from Topco Associates LLC, marketed since Jan 2011 and currently FDA-listed, this package's marketing is listed to end Jun 2028. It is this product's only package size.

NDC 36800-0481-49
🏷️ FDA NDC (as labeled) 36800-481-49 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 36800-481-49 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
36800 labeler · 481 product · 49 package
Package marketed since
Nov 15, 2012
Package marketing ended
Jun 26, 2028
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 3680048149 8
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-481-49
Product NDC 36800-481
11-digit billing NDC 36800048149
RxCUI 1038929
UNII 8ZYQ1474W7, RU45X2JN0Z
Application # M022
SPL Set ID ac398ff0-0010-4e13-8b89-dc986fd7f974
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-01-20
Marketing end 2028-06-26
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Quick answers
  • RxCUI (RxNorm): 1038929
Why two NDCs? The FDA registers this code as 36800-481-49 — 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 → 36800-0481-49. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly it helps prevent cavities. Some toothpastes are also labeled for tooth sensitivity (H E B) or for bleeding gums and plaque linked to gingivitis (CVS Pharmacy). Check your pr...
  • For the 365 Whole Foods Market and Equate rinses, use it twice a day after brushing, if you're 6 or older. Swish 10 mL (2 teaspoonfuls) for 1 minute, then spit it out. Don't eat or...
  • Yes, with care. Children under 6 should be taught to spit and be supervised, and many toothpastes call for a pea-sized amount. Check the age directions on your product. Under 2 yea...
  • If more than a normal brushing amount is swallowed, get medical help or call Poison Control right away. Don't wait for symptoms.
📖 Read our full Fluoride guide →

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.
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
36800-0481-49 You're viewing this Main listing 1 TUBE in 1 CARTON / 113 g in 1 TUBE 2012-11-15 Jun 26, 2028 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Topco Associates LLC Maximum Strength .15 g/100g; 5 g/100g 36800-0364-10 Topco 1 tube — — FDA listed —
HEB Extra Whitening .15 g/100g; 5 g/100g 37808-0681-19 HEB 1 tube — — Discontinued —
Rite Aid Extra Whitening .15 g/100g; 5 g/100g 11822-5020-09 Rite 1 tube — — FDA listed —
CVS Enamel Guard .15 g/100g; 5 g/100g 51316-0128-89 CVS 1 tube — — FDA listed —
HEB Extra Whitening .15 g/100g; 5 g/100g 37808-0961-19 HEB 1 tube — — FDA listed —
Quality Choice Natural White .15 g/100g; 5 g/100g 63868-0172-23 CHAIN 1 tube — — Discontinued —
Topco Associates LLC Maximum Strength .15 g/100g; 5 g/100gthis 36800-0481-49 Topco 1 tube — — FDA listed —
Top Care Enamel Guard .15 g/100g; 5 g/100g 36800-0681-19 TOPCO 1 tube — — FDA listed —
CVS Extra Whitening .15 g/100g; 5 g/100g 59779-0122-29 CVS 1 tube — — Discontinued —
Pronamel Repair Whitening .15 g/100g; 5 g/100g 11822-6310-01 Rite 1 tube — — FDA listed —
Care One Maximum Strength .15 g/100g; 5 g/100g 41520-0415-09 American 1 tube — — FDA listed —
Care One Maximum Strength .15 g/100g; 5 g/100g 41520-0582-19 American 1 tube — — FDA listed —
Kroger Extra Whitening .15 g/100g; 5 g/100g 30142-0149-99 Kroger 1 tube — — FDA listed —
Lornamead Natural White .15 g/100g; 5 g/100g 62721-0470-07 Lornamead 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

🏛️
2011
On the market since
Jan 2011
📍
2026
Currently FDA-listed
15 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.

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.

🧪 Avoiding an ingredient? See Fluoride inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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.

Manufacturer & labeler

LabelerTopco Associates LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedJan 2011
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 36800

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 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 62 words ▾

Directions Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

⏱️ Dosage and Administration 26 words ▾

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

⚠️ Warnings 65 words ▾

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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 14 words ▾

Active ingredients / Purpose Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

🎯 Purpose 8 words ▾

Uses aids in the prevention of dental cavities

📄 Keep Out of Reach of Children 27 words ▾

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.

📄 Other Information 15 words ▾

Other Information Store in a cool dry place. Keep tube capped when not in use.

📄 Package Label / Principal Display Panel 2 words ▾

Carton Artwork

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

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 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 it is currently marketed — but Topco Associates LLC has reported a marketing end date of 2028-06-26, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates 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.
← 36800-0478-48 · Topco 36800-0482-86 · Topco →
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.