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Amerfresh Toothpowder Sodium Fluoride .1 g/100g Powder — NDC 85162-0007-01 package photo

Amerfresh Toothpowder Sodium Fluoride .1 g/100g Powder

by Yangzhou ONE & ONLY Personal Care Products Co., LTD · 40 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE
NDC 85162-0007-01
🏷️ FDA NDC (as labeled) 85162-007-01 billing pads the product segment with a zero
This package
Contains454 g in 1 package Pack sizes2 compare ↓
Also comes in: 50 pouches 85162-0007-02
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 85162-007-01
Product NDC 85162-007
11-digit billing NDC 85162000701
RxCUI 245598
UNII 8ZYQ1474W7
Application # M021
SPL Set ID 1cacf93e-aa60-4717-87ab-0568a701a4f3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-13
Route TOPICAL
Dosage form POWDER
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 85162-007-01 — 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 → 85162-0007-01. 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.

🏭 Manufacturer & labeler

LabelerYangzhou ONE & ONLY Personal Care Products Co., LTD
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code85162
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio5 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?

Amerfresh Toothpowder is a topical powder containing sodium fluoride, an OTC monograph dental product. Sodium fluoride is commonly used in oral hygiene products to help strengthen tooth enamel and reduce cavity formation. This powder form is applied directly to the teeth during brushing, similar to toothpaste.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 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.

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

The official label also statesCalcium carbonate, Silica, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Methylparaben, Propylparaben

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 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: 50 pouches
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
Charm Tex FLUORIDE Gel .1 g/100g 42086-0052-01 Jiangsu 1000 tubes — — FDA listed —
botalab HERBAL COMPLETE TOOTH .22 g/100g 50555-0201-02 KMPHARMACEUTICAL 1 tube — — FDA listed —
Freshmint Anticavity Fluoride 2.2 mg/g 51824-0068-01 New 7.9 g — — FDA listed —
Maximum Security 2.2 mg/g 53247-0130-01 Bob 4.3 g — — FDA listed —
CinnaFresh 2.2 mg/g 53247-0134-01 Bob 24 g — — FDA listed —
Maximum Security 2.2 mg/g 53247-0143-01 Bob 4.3 g — — Discontinued —
Sodium fluoride .22 g/100g 65517-2000-00 DUKAL 17 g — — Discontinued —
DawnMist Gel Fluoride .22 g/100g 65517-2004-00 Dukal 78 g — — FDA listed —
DawnMist .22 g/100g 65517-2005-00 Dukal 17 g — — FDA listed —
Dawnmist Fluoride .22 g/100g 65517-2017-00 Dukal 78 g — — Discontinued —
Sodium Fluoride 220 mg/g 67777-0180-03 Dynarex 144 tubes — — FDA listed —
Bubble Fresh Toothpaste, with Fluoride 220 mg/g 67777-0191-03 Dynarex 144 tubes — — FDA listed —
Fluoride .22 g/g 68599-9573-01 McKesson 24.1 g — — FDA listed —
Botao Kids Strawberry Flavored with Fluoride .122 g/100mL 69435-1405-01 Peer 1 tube — — FDA listed —
Gerigentle-Good morning .22 g/100g 69771-0091-38 Geri-Gentle 43 g — — FDA listed —
Charm Tex FLUORIDE Gel .1 g/100g 71035-0002-01 Yangzhou 1000 tubes — — FDA listed —
ZONSEN Gel Fluoride .22 g/100g 72932-0015-00 Wuhan 17 g — — FDA listed —
ZONSEN Toothpaste,white .22 g/100g 72932-0016-00 Wuhan 17 g — — FDA listed —
DOCTRUST DOUBLEX Tooth .22 g/100g 73242-1122-02 DONG 1 tube — — FDA listed —
DOCTRUST DOUBLEX Tooth .22 g/100g 76670-0010-02 DOCSMEDI 1 tube — — FDA listed —
Dr. Jen SuperPaste Nano-Hydroxyapatite .22 g/100mL 84181-0357-05 Dr 1 tube — — FDA listed —
Dr. Jen SuperPaste Perio .22 g/100mL 84181-0358-08 Dr 1 tube — — FDA listed —
Dr. Jen SuperPaste Ortho .22 g/100mL 84181-0359-09 Dr 1 tube — — FDA listed —
Dr. Jen SuperPaste Nano-Hydroxyapatite .22 g/100mL 84181-0735-07 Dr 1 tube — — FDA listed —
Willo Bubble Twist 1 mg/mL 84185-0102-08 Willo 237 ml — — FDA listed —
Willo Berry Splash Dye Free 1 mg/mL 84185-0202-08 Willo 237 ml — — FDA listed —
AMERFRESH FLUORIDE gel .1 g/100g 85162-0001-01 Yangzhou 144 tubes — — FDA listed —
Amerfresh Fluoride .1 g/100g 85162-0002-01 Yangzhou 144 tubes — — FDA listed —
AdoptaPlatoon .1 g/100mL 85162-0004-01 Yangzhou 10 ml — — FDA listed —
Amerfresh Toothpowder .1 g/100gthis 85162-0007-01 Yangzhou 454 g — — FDA listed —
Maximum Security Anticavity Gel fresh mint flavor .1 g/100g 85891-0008-01 SPARROW 4.25 g — — Discontinued —
Osstem G Gum Health Care Tooth .22 g/100g 87548-0020-02 Osstem 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
Aug 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85162-0007-01 You're viewing this 40 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE 2025-08-13 Active
85162-0007-02 4 BOX in 1 CARTON (85162-007-02) / 50 POUCH in 1 BOX / 57 g in 1 POUCH 2025-08-13 Active

Pack size FAQ

What quantity is in NDC 85162-0007-01?
NDC 85162-0007-01 is listed by the FDA — 40 package in 1 carton / 454 g in 1 package.
What NDC number is used to bill for this package of Amerfresh Toothpowder Sodium Fluoride .1 g/100g Powder?
Bill NDC 85162-0007-01 — the 11-digit billing format is 85162000701. 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 85162-007-01, 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: 85162-0007-01, written without dashes as 85162000701. 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 85162-0007-01, the first segment (85162) is the labeler code FDA assigned to Yangzhou ONE & ONLY Personal Care Products Co., LTD; the middle segment (0007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Yangzhou ONE & ONLY Personal Care Products Co., LTD. 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 50 pouches (85162-0007-02). 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?
Yangzhou ONE & ONLY Personal Care Products Co., LTD 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 8 words ▾

Uses aids in the prevention of dental cavities.

⏱️ Dosage and Administration 101 words ▾

Directions For Use: Wet toothbrush and dip into powder until brush is fully covered. Brush teeth and gum line for tleast 30 seconds, rinse and spit out thoroughly do not swallow . supervise children as necessary until capable of useing without supervision instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). 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 a physician.

Children under 6 years of age:do not use unless directed by a doctor or dentist.

⚠️ Warnings 42 words ▾

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

🧪 Active Ingredient 11 words ▾

Active ingredients Sodium Fluoride 0.22%(0.1 w/v Fluoride ion) Purpose Anticavity toothpaste

🧪 Inactive Ingredients 13 words ▾

INACTIVE INGREDIENT Calcium carbonate, Silica, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Methylparaben, Propylparaben

🎯 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 ↗
← 85162-0004-01 · Yangzhou 85163-0001-01 · Shantou →
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.