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SprinJene Fresh Boost Sodium Fluoride 1.5 mg/g Gel, Dentifrice — NDC 63404-0910-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SprinJene Fresh Boost Sodium Fluoride 1.5 mg/g Gel, Dentifrice — NDC 63404-0910-1 (Billing 63404-0910-01)

by Health and Natural Beauty USA Corp · 1 TUBE in 1 CARTON / 130 g in 1 TUBE

This is a package of SprinJene Fresh Boost Sodium Fluoride 1.5 mg/g Gel, Dentifrice from Health and Natural Beauty USA Corp, marketed since Oct 2014 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63404-0910-01
🏷️ FDA NDC (as labeled) 63404-0910-1 billing pads the package segment with a zero
This package
Contains130 g in 1 tube Pack sizes3 compare ↓
Main listing for product 63404-0910 · Also comes in: 42 g 63404-0910-2 75 g 63404-0910-3
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 63404-0910-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63404 labeler · 0910 product · 1 package
Package marketed since
Oct 10, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0363404000923
FDA record last changed
Sep 3, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63404-0910-1
Product NDC 63404-0910
11-digit billing NDC 63404091001
RxCUI 891775
UNII 8ZYQ1474W7
UPC 0363404000923
Application # M021
SPL Set ID 919f6f51-6c43-4f1c-9bc7-029bf76c0e68
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-10-10
Route DENTAL
Dosage form GEL, DENTIFRICE
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 891775
Why two NDCs? The FDA registers this code as 63404-0910-1 — 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 → 63404-0910-01. 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?

SprinJene Fresh Boost is an over-the-counter toothpaste gel that contains sodium fluoride as its active ingredient. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce the risk of tooth decay. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for over-the-counter fluoride dentifrices rather than being individually reviewed as a new drug application.

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: 42 g 75 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
63404-0910-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 130 g in 1 TUBE 2014-10-10 — Active
63404-0910-02 63404-0910-2 1 TUBE in 1 CARTON / 42 g in 1 TUBE 2014-10-10 — Active
63404-0910-03 63404-0910-3 1 TUBE in 1 CARTON / 75 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 / 130 g in 1 tube.
What NDC number is used to bill for this package of SprinJene Fresh Boost Sodium Fluoride 1.5 mg/g Gel, 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
Hello Vitamin C Whitening 1.5 mg/g 35000-0689-10 Colgate-Palmolive 1 tube — — FDA listed —
Farmasi Whitening 1.5 mg/g 74690-0012-01 Farmasi 1 tube — — FDA listed —
Crest 3D White Advanced Glamorous White with Stain-Blasting Foam 1.5 mg/g 84126-0632-03 The 1 cello — — FDA listed —
Orajel Toy Story 5 Anticavity 1.5 mg/g 10237-0734-42 Church 119 g — — FDA listed —
Crest Cavity Protection Cool Mint Gel 1.5 mg/g 37000-0025-08 The 1 tube — — FDA listed —
Crest 3D White Whitening Therapy Deep Clean Charcoal 1.5 mg/g 37000-0215-24 Procter 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint 1.5 mg/g 43136-0593-11 Tai 1 tube — — FDA listed —
Crest Cavity Protection Cool Mint 1.5 mg/g 50090-6233-00 A-S 24 tubes — — FDA listed —
Euthymol Whitening 1.5 mg/g 53208-0566-65 LG 1 tube — — FDA listed —
Made by Dentists For Kids Monster Slime 1.5 mg/g 62776-0002-01 Fulijaya 1 tube — — FDA listed —
Crest 3D White Advanced Radiant Mint 1.5 mg/g 69423-0770-22 The 2 tubes — — Discontinued —
Crest Cavity Protection Cool Mint Gel 1.5 mg/g 69423-0815-11 The 2 tubes — — FDA listed —
Crest Plus Active Fresh plus Whitening Scope 1.5 mg/g 69423-0823-55 The 1 tube — — FDA listed —
Crest Plus Whitening Deep Clean 1.5 mg/g 69423-0842-02 The 2 tubes — — FDA listed —
Crest Fresh and White 1.5 mg/g 69423-0897-24 The 1 tube — — FDA listed —
Crest Complete Plus Scope Outlast Ultra 1.5 mg/g 69423-0918-65 The 1 tube — — FDA listed —
Crest 3D White Ultra Whitening with Stain-Blasting Foam Vivid Mint 1.5 mg/g 84126-0653-05 The 1 cello — — FDA listed —
Hello Dragon Dazzle Dragon Dazzle Fluoride 1.5 mg/g 35000-0679-10 Colgate-Palmolive 1 tube — — FDA listed —
Crest Cavity Protection Regular 1.5 mg/g 37000-0005-01 The 2.5 g — — Discontinued —
Crest Strawberry 1.5 mg/g 37000-0171-42 The 119 g — — FDA listed —
Crest Complete Plus Scope Outlast 1.5 mg/g 37000-0983-04 The 130 g — — FDA listed —
Crest Premium Plus Scope Dual Blast Active Foam 1.5 mg/g 37000-0990-03 The 1 cello — — Discontinued —
Crest Premium Plus Scope Outlast Active Foam 1.5 mg/g 37000-0991-03 The 1 cello — — FDA listed —
Crest Kids SparkleFun Bubblegum 1.5 mg/g 58933-0023-42 Procter 119 g — — FDA listed —
Crest Strawberry 1.5 mg/g 58933-0045-42 Procter 119 g — — FDA listed —
Crest Fresh and White 1.5 mg/g 58933-0868-02 Procter 1 tube — — Discontinued —
Crest Cavity Protection Regular 1.5 mg/g 67751-0124-01 Navajo 1 tube — — FDA listed —
Crest 3D White Advanced Charcoal 1.5 mg/g 69423-0767-27 The 1 tube — — FDA listed —
Crest 3D White Advanced Deep Clean 1.5 mg/g 69423-0836-23 Procter 2 tubes — — FDA listed —
Crest 4in1 1.5 mg/g 69423-0852-24 The 1 tube — — FDA listed —
Complete Care Whole Mouth Protection 1.5 mg/g 10237-0675-09 Church 1 tube — — FDA listed —
Orajel KidsToothpaste 1.5 mg/g 10237-0785-42 Church 119 g — — FDA listed —
Crest Complete Plus 3 in 1 1.5 mg/g 37000-0984-04 The 130 g — — FDA listed —
Crest Cavity Protection Regular 1.5 mg/g 58933-0005-04 Procter 1 tube — — Discontinued —
Crest Tartar Protection 1.5 mg/g 58933-0008-02 Procter 1 tube — — Discontinued —
Crest Strawberry 1.5 mg/g 58933-0171-42 Procter 119 g — — FDA listed —
Crest 3D White Stain Eraser 1.5 mg/g 58933-0879-23 Procter 1 tube — — FDA listed —
Crest Plus Cinnamon Expressions plus Whitening 1.5 mg/g 69423-0840-23 The 1 tube — — FDA listed —
Made by Dentists For Kids Eyeball Juice (Watermelon) 1.5 mg/g 75065-0024-06 MADE 1 tube — — FDA listed —
Crest 3D White Advanced Charcoal with Stain-Blasting Foam 1.5 mg/g 84126-0634-03 The 1 cello — — FDA listed —
Kids Crest Strawberry Rush 1.5 mg/g 37000-0511-42 The 1 tube — — FDA listed —
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions 1.5 mg/g 37000-0943-06 The 1 tube — — Discontinued —
Crest Premium Plus Deep Clean Active Foam 1.5 mg/g 37000-0994-52 The 1 tube — — FDA listed —
Made by Dentists For Kids Eyeball Juice 1.5 mg/g 62776-0001-01 Fulijaya 1 tube — — FDA listed —
Made by Dentist For Kids Chew Toy Bubblegum 1.5 mg/g 62776-0006-01 Fulijaya 1 tube — — FDA listed —
Crest 3D White Advanced Express White 1.5 mg/g 69423-0762-38 The 1 tube — — FDA listed —
Crest Complete Plus Active Fresh plus Whitening Scope 1.5 mg/g 69423-0932-55 The 1 tube — — FDA listed —
Crest 3D White Sparkle Mint 1.5 mg/g 84126-0620-24 The 1 tube — — FDA listed —
Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam 1.5 mg/g 84126-0628-04 The 1 cello — — FDA listed —
Crest 3D White Advanced Deep Clean with Stain-Blasting Foam 1.5 mg/g 84126-0631-33 The 1 tube — — FDA listed —
Crest Tartar Protection 1.5 mg/g 37000-0008-02 The 1 tube — — Discontinued —
Crest Fresh and White 1.5 mg/g 37000-0868-02 The 1 tube — — Discontinued —
Crest 3D White Brilliance Bright Mint 1.5 mg/g 84126-0601-43 Procter 1 tube — — FDA listed —
Crest Complete plus Scope Pro Advanced Freshness 1.5 mg/g 84126-0614-01 The 1 tube — — FDA listed —
Crest Plus Cinnamon plus Whitening 1.5 mg/g 84126-0655-23 The 1 tube — — FDA listed —
Crest Tartar Protection Fresh Mint Gel 1.5 mg/g 37000-0009-06 The 1 tube — — Discontinued —
Kids Crest Bubblegum Flavor 1.5 mg/g 37000-0839-01 The 119 g — — FDA listed —
HIMALAYA PINK SALT Intensive Whitening Spearmint 1.5 mg/g 53208-0591-20 LG 1 tube — — FDA listed —
Crest Complete Multi-Benefit Whitening plus Scope 1.5 mg/g 58933-0020-03 Procter 1 tube — — FDA listed —
Crest Bubblegum 1.5 mg/g 58933-0046-42 Procter 119 g — — FDA listed —
Crest plus Tartar Protection Whitening 1.5 mg/g 69423-0818-57 The 1 tube — — FDA listed —
Crest 3D White Ultra Vivid Mint 1.5 mg/g 69423-0850-52 The 1 tube — — FDA listed —
Orajel Paw Patrol 1.5 mg/g 10237-0786-42 Church 119 g — — FDA listed —
Hello Kids Wild Strawberry Wild Strawberry 1.5 mg/g 35000-0688-10 Colgate-Palmolive 1 tube — — FDA listed —
Crest Complete plus Whitening plus Scope Outlast 1.5 mg/g 37000-0445-40 The 1 tube — — FDA listed —
Crest Complete Multi Benefit Whitening plus Scope Outlast 1.5 mg/g 37000-0504-05 The 1 cello — — Discontinued —
Euthymol Whitening Purple Corrector 1.5 mg/g 53208-0563-65 LG 1 tube — — FDA listed —
Crest Strawberry 1.5 mg/g 58933-0048-42 Procter 119 g — — FDA listed —
Crest 3D White Stain Eraser Icy Clean Mint 1.5 mg/g 58933-0932-35 Procter 1 tube — — FDA listed —
Made by Dentists For Kids Cheetah Dust 1.5 mg/g 62776-0000-01 Fulijaya 1 tube — — FDA listed —
Crest 3D White Advanced Stain Shield 1.5 mg/g 69423-0772-38 The 1 tube — — FDA listed —
Crest Complete plus Whitening 1.5 mg/g 69423-0894-54 The 1 tube — — FDA listed —
Crest Complete plus Whitening plus Scope 1.5 mg/g 69423-0933-02 The 2 tubes — — FDA listed —
Made by Dentist for Kids Chew Toy (Bubblegum) 1.5 mg/g 75065-0031-06 MADE 1 tube — — FDA listed —
Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep 1.5 mg/g 84126-0633-37 The 1 tube — — FDA listed —
Crest Bubblegum 1.5 mg/g 37000-0174-42 The 119 g — — FDA listed —
Crest 3D White Radiant Mint 1.5 mg/g 37000-0876-01 The 1 tube — — FDA listed —
Crest 3D White Charcoal 1.5 mg/g 37000-0945-02 Procter 1 cello — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste 1.5 mg/g 53208-0592-10 LG 1 tube — — FDA listed —
Crest Bubblegum 1.5 mg/g 58933-0047-42 Procter 119 g — — FDA listed —
Crest Plus Cavity Protection Cool Mint Gel 1.5 mg/g 69423-0816-57 The 1 tube — — FDA listed —
Crest Plus Tartar Protection 1.5 mg/g 69423-0817-24 The 1 tube — — FDA listed —
Crest Premium Plus Active Foam Whitening scope 1.5 mg/g 69423-0949-52 The 1 tube — — FDA listed —
Made by Dentists For Kids Alien Blood 1.5 mg/g 75065-0026-06 MADE 1 tube — — Discontinued —
Crest Plus Deep Clean plus Whitening 1.5 mg/g 84126-0656-23 The 1 tube — — Discontinued —
Crest Premium Plus Advanced Whitening Active Foam 1.5 mg/g 37000-0993-72 The 1 tube — — FDA listed —
HIMALAYA PINK SALT Intensive Whitening Spearmint 1.5 mg/g 43136-0591-20 Tai 1 tube — — FDA listed —
Crest 3D White Fresh Mint 1.5 mg/g 58933-0881-23 Procter 1 tube — — FDA listed —
Made by Dentists Ultra Whitening Fresh Mint 1.5 mg/g 75065-0027-06 MADE 1 tube — — FDA listed —
Made by Dentists For Kids Eyeball Juice (Watermelon) 1.5 mg/g 75065-0030-07 MADE 1 tube — — FDA listed —
Crest 3D White Advanced Radiant Mint with Stain Blasting Foam 1.5 mg/g 84126-0629-02 The 1 cello — — FDA listed —
Kids Crest Cavity Protection Sparkle Fun 1.5 mg/g 37000-0049-01 The 1 tube — — FDA listed —
Crest 3D White Brilliance Charcoal 1.5 mg/g 37000-0989-39 Procter 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste 1.5 mg/g 43136-0592-10 Tai 1 tube — — FDA listed —
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint 1.5 mg/g 53208-0593-11 LG 1 tube — — FDA listed —
Kids Crest Cavity Protection Sparkle Fun 1.5 mg/g 58933-0049-01 Procter 24 g — — FDA listed —
Made by Dentists Ultra Whitening Professional 1.5 mg/g 62776-0005-01 Fulijaya 1 tube — — FDA listed —
Crest Complete plus Whitening Deep Clean 1.5 mg/g 69423-0911-54 The 1 tube — — FDA listed —
Made by Dentists For Kids Monster Slime Sour Apple 1.5 mg/g 75065-0023-06 MADE 1 tube — — FDA listed —
Made by Dentists For Kids Cheetah Dust (Strawberry) 1.5 mg/g 75065-0025-06 MADE 1 tube — — FDA listed —
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum) 1.5 mg/g 75065-0032-06 Made 1 tube — — FDA listed —
Crest Plus Scope plus Whitening with Mouthwash 1.5 mg/g 84126-0658-23 The 1 tube — — FDA listed —
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash 1.5 mg/g 84126-0659-23 The 1 tube — — FDA listed —
Crest Premium Plus Active Foam Whitening scope 1.5 mg/g 84126-0660-03 The 3 tubes — — FDA listed —
Crest Plus Extra Whitening 1.5 mg/g 84126-0666-54 The 1 tube — — FDA listed —
Crest Plus Active Fresh Scope plus Whitening 1.5 mg/g 84126-0665-04 The 1 cello — — FDA listed —
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint 1.5 mg/g 84126-0661-03 The 3 tubes — — FDA listed —
Crest Plus Scope plus Whitening Outlast Mint 1.5 mg/g 84126-0663-02 The 2 tubes — — FDA listed —
Crest Plus Scope plus Whitening Outlast Mint 1.5 mg/g 84126-0664-23 The 1 tube — — FDA listed —
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint 1.5 mg/g 84126-0662-52 The 1 tube — — FDA listed —
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash striped 1.5 mg/g 84126-0669-02 The 2 tubes — — FDA listed —
Crest plus Tartar Protection Whitening 1.5 mg/g 84126-0670-24 The 1 tube — — FDA listed —
CrestPlus Deep Clean plus Whitening Effervescent Mint 1.5 mg/g 84126-0667-02 The 2 tubes — — FDA listed —
Crest Premium Plus Scope Active Foam plus Whitening Minty Fresh 1.5 mg/g 84126-0668-03 The 3 tubes — — FDA listed —
SprinJene Fresh Boost 1.5 mg/gthis 63404-0910-01 Health 1 tube — — FDA listed —
SprinJene White Boost 1.5 mg/g 63404-1116-01 Health 1 tube — — FDA listed —
Crest Plus Scope plus Whitening Ultra Mint 1.5 mg/g 84126-0672-04 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

🏛️
2014
On the market since
Oct 2014
📍
2026
Currently FDA-listed
12 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 Green
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.

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

LabelerHealth and Natural Beauty USA Corp
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code63404
First marketedOct 2014
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Health and Natural Beauty USA Corp labeler code 63404

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 7 words ▾

Use Helps in the prevention of caries

⏱️ 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 habbits (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 Fluoride 0.243% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients Water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, zinc citrate, black seed oil, xanthan, sodium saccharin, mica, FD&C Blue No. 1, FD&C Yellow No. 5

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 31 words ▾

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.

📄 Questions or Comments 8 words ▾

Questions or comments? Call toll free 1-844-3-462872 www.sprinjene.com

📄 Package Label / Principal Display Panel 49 words ▾

PRINCIPAL DISPLAY PANEL - 75 g Tube Carton SprinJene ® Fluoride Toothpaste NET WT

2.6OZ (75 g) Bursting with the unique benefits of Black Seed Oil VEGAN V BeVeg! BeVeg CERTIFIED ADA Accepted American Dental Association ® Fresh Boost Gel Principal Display Panel - 75 g Tube Carton

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 ✓ Available
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: 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (63404-0910-02), 1 tube (63404-0910-03). 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?
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.
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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.