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Sodium Fluoride .5 mg/mL Solution/ Drops, 50 mL — NDC 58657-0322-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Fluoride .5 mg/mL Solution/ Drops, 50 mL — NDC 58657-322-50 (Billing 58657-0322-50)

by Method Pharmaceuticals, LLC · 50 mL in 1 BOTTLE, DROPPER

This is a package of 50 mL of Sodium Fluoride .5 mg/mL Solution/ Drops from Method Pharmaceuticals, LLC, marketed since Aug 2018 and currently FDA-listed; retail pharmacies pay about $0.1556 per mL (NADAC). It is this product's only package size.

NDC 58657-0322-50
🏷️ FDA NDC (as labeled) 58657-322-50 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58657-322-50
Product NDC 58657-322
11-digit billing NDC 58657032250
NCPDP billing unit ML — per mL (volume)
RxCUI 315102
UNII 8ZYQ1474W7
SPL Set ID 35dcc144-130d-4ec7-a266-c084008ac70c
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-15
Route ORAL
Dosage form SOLUTION/ DROPS
Substance SODIUM FLUORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79300020002050
GPI class Sodium Fluoride
GCN Seq No 002619
GCN 07473
HICL code 001127
Ingredient (HICL) Fluoride (Sodium)
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D2
Therapeutic class — intermediate (HIC2) Drugs Acting On Teeth
HIC3 code D2A
Therapeutic class — specific (HIC3) Fluoride Preparations
AHFS code 34:04.00.00
AHFS class Nutritional Supplements
FDB label name SODIUM FLUORIDE 0.5 MG/ML DROP
FDB brand name Sodium Fluoride
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Quick answers
  • GSN (GCN sequence number): 002619
  • GCN: 07473
  • GPI-14 (Medi-Span): 79300020002050
  • HICL (First Databank): 001127
  • AHFS class code: 34:04.00.00
  • RxCUI (RxNorm): 315102
Why two NDCs? The FDA registers this code as 58657-322-50 — 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 → 58657-0322-50. 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

Label name SODIUM FLUORIDE 0.5 MG/ML DROP Ingredient Fluoride (Sodium)
📖 About the active ingredient: Sodium Fluoride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

Sodium Fluoride 0.5 mg/mL Solution/Drops is an oral liquid form of sodium fluoride, a mineral compound. Sodium fluoride is typically used to strengthen tooth enamel and help prevent tooth decay. This product is marketed without an FDA-approved application. The solution is administered as drops by mouth, usually during childhood when teeth are still developing.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.156 $7.78 / 50 ml
Medicaid paysCMS SDUD · 12 mo $0.2795 $13.98 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.254 $0.145
▼ Down 38% over the last 24 months.
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
58657-0322-50 You're viewing this Main listing 50 mL in 1 BOTTLE, DROPPER 2018-08-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Fluoride .5 mg/mLthis 58657-0322-50 Method 50 ml $0.156 — Availability likely —
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh .5 mg/mL 00135-0451-01 Haleon 500 ml — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint .5 mg/mL 00135-0449-01 Haleon 500 ml — — 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 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

FlavorGrape
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 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 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

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

LabelerMethod Pharmaceuticals, LLC
Labeler code58657
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio78 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 78 words ▾

Indications and Usage As a supplemental source of Fluoride. It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries.1 Sodium Fluoride Drops were developed to provide systemic Fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water Fluoride level does not exceed 0.6 ppm F.

⛔ Contraindications 24 words ▾

Contraindications Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

⚠️ Warnings 48 words ▾

Warnings Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of the reach of infants and children.

🤒 Adverse Reactions 38 words ▾

Adverse Reactions Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Method Pharmaceuticals, LLC at 877-250-3427. Store at controlled room temperature 15° to 30°C (59° to 86°F).

🧬 Clinical Pharmacology 30 words ▾

Clinical Pharmacology Sodium Fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization and by inhibiting the cariogenic microbial process.

📦 How Supplied / Storage and Handling 6 words ▾

How Supplied 50 mL bottles (58657-322-50)

📋 Description 213 words ▾

Description Each mL of Sodium Fluoride Drops contains 0.5 mg Fluoride ion (F) from 1.1 mg Sodium Fluoride (NaF). For use as a dental caries preventive in pediatric patients. Sugar Free, Alcohol Free, Dye Free and Gluten Free.

Supplement Facts Serving Size: 1 mL Servings Per Container: 50 Amount per serving % Daily Value Fluoride (as Sodium Fluoride) 0.5 mg ** ** Daily Value not established. Active Ingredients: Sodium Fluoride (0.11% w/v). Other Ingredients: Glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

FLUORIDE SUPPLEMENT DOSAGE SCHEDULES AGE Fluoride Ion Level in Drinking Water (ppm)* < 0.3 ppm 0.3 - 0.6 ppm > 0.6 ppm Birth to 6 months None None None 6 months to 3 years Half dropperful 0.25 mg F (1/2 mL) None None 3 to 6 years One dropperful 0.5 mg F (1 mL)† Half dropperful 0.25 mg F (1/2 mL) None 6 to 16 years Two dropperfuls 1 mg F (2 mL) One dropperful 0.5 mg F (1 mL) None * 1.0 ppm = 1 mg/Liter † 1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion Fluoride Supplement Dose Schedule approved by the American Dental Association, American Academy of Pediatrics and American Academy of Pediatric Dentistry.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

⚠️ Precautions 31 words ▾

Precautions See " Overdosage " section. Incompatibility of Fluoride with dairy foods has been reported due to formation of Calcium Fluoride which is poorly absorbed. Not for use in the eyes.

📚 References 36 words ▾

References 1. Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984:399-402. 2. Jakush, J, New Fluoride Schedule Adopted. ADA News. May 16, 1994:12-14. Manufactured by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev. 07/2018 dropper

📄 Package Label / Principal Display Panel 23 words ▾

PRINCIPAL DISPLAY PANEL NDC 58657-322-50 Sodium Fluoride Drops Sodium Fluoride Oral Solution, USP 0.5 mg/mL GRAPE FLAVORED

1.69FL. OZ. (50 mL) carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12.3K
Units reimbursed last 4 qtrs
628.7K
Gross reimbursed last 4 qtrs
$175.7K
Avg / prescription
$14.33
Avg / unit
$0.2795
Latest quarter Q4 2025
3.6KRx
Medicaid pays / mL
$0.2795
gross reimbursed
vs
NADAC / mL
$0.1556
acquisition cost
=
Spread
+$0.1239
+80% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
39% FFS 61% MCO
Fee-for-service · 4,739 Rx Managed care · 7,523 Rx
State Medicaid map
Alaska: no data reported AK Maine: 700 units · 50.2 per 100k residents ME Washington: 54,745 units · 701 per 100k residents WA Idaho: no data reported ID Montana: 2,110 units · 186 per 100k residents MT North Dakota: no data reported ND Minnesota: 550 units · 9.6 per 100k residents MN Wisconsin: 12,050 units · 204 per 100k residents WI Michigan: 6,650 units · 66.3 per 100k residents MI New York: 48,845 units · 250 per 100k residents NY Vermont: 20,550 units · 3,176 per 100k residents VT New Hampshire: 2,100 units · 150 per 100k residents NH Oregon: 120,795 units · 2,854 per 100k residents OR Nevada: 2,800 units · 87.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 5,650 units · 47.9 per 100k residents OH Pennsylvania: 37,166 units · 287 per 100k residents PA New Jersey: 19,125 units · 206 per 100k residents NJ Massachusetts: 33,775 units · 482 per 100k residents MA California: 139,055 units · 357 per 100k residents CA Utah: 24,455 units · 716 per 100k residents UT Colorado: 3,145 units · 53.5 per 100k residents CO Nebraska: no data reported NE Missouri: 4,750 units · 76.7 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 5,595 units · 64.2 per 100k residents VA Maryland: 7,180 units · 116 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 3,600 units · 33.2 per 100k residents NC South Carolina: no data reported SC Delaware: 2,550 units · 247 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 12,320 units · 419 per 100k residents MS Alabama: no data reported AL Georgia: 2,250 units · 20.4 per 100k residents GA D.C.: no data reported DC Hawaii: 56,150 units · 3,913 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
9.63,913
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 3,913 /100k
2 Vermont 3,176 /100k
3 Oregon 2,854 /100k
4 Utah 716 /100k
5 Washington 701 /100k
6 Massachusetts 482 /100k
7 Mississippi 419 /100k
8 California 357 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Fluoride — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Fluoride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$487K
Claims incl. refills
44K
Beneficiaries
34K
Spend / beneficiary
$14.31
Spend / claim
$11.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) ✓ Available
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) ✓ Available
“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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Method Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Method Pharmaceuticals, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 58657-0234-01 · Method 58657-0323-50 · Method →
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.