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SprinJene Natural Sodium Monofluorophosphate 1.5 mg/g Paste, Dentifrice — NDC 63404-0201-01 package photo

SprinJene Natural Sodium Monofluorophosphate 1.5 mg/g Paste, Dentifrice

by Health and Natural Beauty USA Corp · 1 TUBE in 1 CARTON (63404-0201-1) / 99 g in 1 TUBE
NDC 63404-0201-01
🏷️ FDA NDC (as labeled) 63404-0201-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 3, 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) 63404-0201-1
Product NDC 63404-0201
11-digit billing NDC 63404020101
RxCUI 545626
UNII C810JCZ56Q
Application # M021
SPL Set ID e64cecc3-0845-4bdf-a449-d78248791ccf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-01
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM MONOFLUOROPHOSPHATE
Why two NDCs? The FDA registers this code as 63404-0201-1 — a 5-4-1 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 package segment → 63404-0201-01. 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

LabelerHealth and Natural Beauty USA Corp
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code63404
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio10 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?

SprinJene Natural is a toothpaste containing sodium monofluorophosphate, a fluoride compound typically used in dental care products. This over-the-counter monograph product is applied topically to the teeth and gums during brushing. Sodium monofluorophosphate functions as a fluoride source commonly included in toothpastes to help strengthen tooth enamel and support oral hygiene routines. This product is marketed as a naturally formulated option within the standard toothpaste category.

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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • 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 62V75NI93W
    A surfactant derived from coconut oil that helps cleanse and remove oils from skin or hair. In medicines and personal care products, it acts as a cleanser and foaming agent.
  • 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 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 CS4U38E731
    A plant-derived oil from nigella sativa seeds, used as a carrier and emollient in formulations. It helps dissolve or suspend active ingredients and improves product texture and absorption.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII D0Y70F2B9J
    A synthetic detergent and surfactant derived from fatty acids. It reduces surface tension in formulations to help with mixing, emulsifying, and creating foams or dispersions in topical products.
  • 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.
  • 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.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
  • UNII K72I3DEX9B
    Zinc citrate is a zinc salt combined with citric acid. It's used in medicines as a source of zinc and sometimes as a buffer to help maintain the product's pH balance.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesWater, Hydrated Silica, Glycerin, Xylitol, 1,3 Propanediol (Zemea - made from non GMO corn), Natural Peppermint Oil, Xanthan Gum, Precipitated Natural Calcium Carbonate, Zinc Citrate, Cocamidopropyl Hydroxysultaine, Zinc Oxide, Nigella Sativa (Black Seed Oil), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Tetrasodium Pyrophosphate, Acacia Gum.

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.
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
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 Pro Series Hi White 1.5 mg/g 65954-0841-63 Mission 1 tube — — FDA listed —
Colgate Optic White Advanced Vibrant Clean 1.5 mg/g 35000-0979-32 Colgate-Palmolive 1 tube — — Discontinued —
Crest Kids Advanced Color Changing 1.5 mg/g 58933-0024-04 Procter 1 cello — — 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 Pro Series Enamel Renewal Soothing Mint 1.5 mg/g 35000-0791-62 Colgate-Palmolive 2 tubes — — FDA listed —
SprinJene Natural 1.5 mg/gthis 63404-0201-01 Health 1 tube — — FDA listed —
SprinJene Health Boost 1.5 mg/g 63404-1108-01 Health 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63404-0201-01 You're viewing this 1 TUBE in 1 CARTON (63404-0201-1) / 99 g in 1 TUBE 2017-02-01 Active

🧭 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 63404-0201-1, 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: 63404-0201-01, written without dashes as 63404020101. 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 63404-0201-01, the first segment (63404) is the labeler code FDA assigned to Health and Natural Beauty USA Corp; the middle segment (0201) 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 Health and Natural Beauty USA Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Health and Natural Beauty USA Corp 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 ▾

Use Aids in the prevention of dental cavities.

⏱️ Dosage and Administration 70 words ▾

Directions Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children under 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing.) Children under 2 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 Control Center right away.

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium Monofluorophosphate 0.76% (0.14 W/V Fluoride Ion)

🧪 Inactive Ingredients 47 words ▾

Inactive Ingredients Water, Hydrated Silica, Glycerin, Xylitol, 1,3 Propanediol (Zemea - made from non GMO corn), Natural Peppermint Oil, Xanthan Gum, Precipitated Natural Calcium Carbonate, Zinc Citrate, Cocamidopropyl Hydroxysultaine, Zinc Oxide, Nigella Sativa (Black Seed Oil), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Tetrasodium Pyrophosphate, Acacia Gum.

🎯 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 ↗
← 63402-0312-04 · Sumitomo 63404-0720-01 · Health →
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.