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PerioMed Stannous Fluoride 1.53 mg/g Rinse — NDC 48878-3315-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PerioMed Stannous Fluoride 1.53 mg/g Rinse — NDC 48878-3315-2 (Billing 48878-3315-02)

by Solventum US LLC · 1 BOTTLE, PLASTIC in 1 BOX / 85 g in 1 BOTTLE, PLASTIC

This is a package of PerioMed Stannous Fluoride 1.53 mg/g Rinse from Solventum US LLC, marketed since Jul 1967 and currently FDA-listed.

NDC 48878-3315-02
🏷️ FDA NDC (as labeled) 48878-3315-2 billing pads the package segment with a zero
This package
Contains85 g in 1 bottle, plastic Pack sizes2 compare ↓
Product page 48878-3315-00 Also comes in: 283.5 g 48878-3315-0
OTC 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) 48878-3315-2
Product NDC 48878-3315
11-digit billing NDC 48878331502
NCPDP billing unit GM — per gram (weight)
UNII 3FTR44B32Q
Application # M021
SPL Set ID 7f79eb00-86df-4284-b415-47f45e4849da
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1967-07-01
Route ORAL
Dosage form RINSE
Substance STANNOUS FLUORIDE

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

GPI-14 88402030001320
GPI class PerioMed
GCN Seq No 059921
GCN 25853
HICL code 001128
Ingredient (HICL) Stannous Fluoride
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 PERIOMED 0.63% DENTAL RINSE
FDB brand name Periomed
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 059921
  • GCN: 25853
  • GPI-14 (Medi-Span): 88402030001320
  • HICL (First Databank): 001128
  • AHFS class code: 34:04.00.00
Why two NDCs? The FDA registers this code as 48878-3315-2 — 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 → 48878-3315-02. 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

Label name PERIOMED 0.63% DENTAL RINSE Ingredient Stannous Fluoride
🧪 What is this product?

PerioMed Stannous Fluoride 1.53 mg/g Rinse is an over-the-counter oral rinse containing stannous fluoride, a fluoride compound typically used in dental care products. Stannous fluoride is commonly used to help strengthen tooth enamel and reduce cavity formation. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual product review.

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 eachPer 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: 283.5 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
48878-3315-00 48878-3315-0 Main listing 1 BOTTLE, PLASTIC in 1 BOX / 283.5 g in 1 BOTTLE, PLASTIC 1967-07-01 — Active
48878-3315-02 You're viewing this 1 BOTTLE, PLASTIC in 1 BOX / 85 g in 1 BOTTLE, PLASTIC 2016-02-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 box / 85 g in 1 bottle, plastic.
What NDC number is used to bill for this package of PerioMed Stannous Fluoride 1.53 mg/g Rinse?
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
Pro-Den Rx 1.53 mg/g 59883-0720-08 Den-mat 1 bottle — — FDA listed —
PerioMed 1.53 mg/gthis 48878-3315-02 Solventum 1 bottle — — FDA listed —
PerioMed 1.53 mg/g 48878-3317-00 Solventum 1 bottle — — 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

🏛️
1967
On the market since
Jul 1967
📍
2026
Currently FDA-listed
59 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

FlavorFruit
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

LabelerSolventum US LLC
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code48878
First marketedJul 1967
Product typeHuman Otc Drug
Portfolio19 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.

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 23 words ▾

Uses aids in the prevention of childhood dental decay helps prevent gingivitis helps control plaque bacteria builds increasing protection against painful tooth sensitivity

⏱️ Dosage and Administration 163 words ▾

Directions adults and children 6 years of age and older: do not use before mixing with water use immediately after preparing the rinse use as directed by a dental professional use once a day after brushing your teeth with a toothpaste or as directed by your dentist remove cap and seal and replace with pump rotate spout counter clockwise to extend depress pump until medicine comes to the tip of the pump put 1/8 oz. (approx. 2 pump strokes) of concentrated PerioMed Rinse into the provided mixing vial add water to 1 oz. line on mixing vial tightly snap on the cap and shake well vigorously swish rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor

⚠️ Warnings 68 words ▾

Warnings When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist. Stop use and ask a doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care. Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active ingredient Stannous fluoride 0.63% w/w (0.19% w/v flouride ion)

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients flavor, glycerin, methyl paraben, propyl paraben, sodium saccharin

🎯 Purpose 5 words ▾

Purpose anticavity, antigingivitis, antihypersensitivity, mouthrinse

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PerioMed (this brand).

Top reported reactions

Dyspnoea5
Nausea5
Oral Discomfort5
Oral Disorder4
Oral Pain4
Vomiting4
Anaemia3

Age at onset

Child1
Adult1
Elderly1

Reporter sex

49 reports
Male · 50%
Female · 50%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Solventum US LLC. 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 1 bottle (48878-3315-00). 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?
Solventum US 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.
← 48878-3150-04 · Solventum 48878-3317-00 · Solventum →
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.