HomeNDC Lookup › 70275-0936-16
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TheraStom antigingivitis/antiplaque mouth rinse .075 mg/.1mL Rinse, 473 mL

by Forward Science Technologies LLC · 473 mL in 1 BOTTLE (70275-936-16)
NDC 70275-0936-16
🏷️ FDA NDC (as labeled) 70275-936-16 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 70275-936-16
Product NDC 70275-936
11-digit billing NDC 70275093616
RxCUI 1599135
UNII D9OM4SK49P
UPC 0370275936169
SPL Set ID c110cf06-98ad-b30c-e053-2995a90a8e53
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-05
Route DENTAL
Dosage form RINSE
Substance CETYLPYRIDINIUM CHLORIDE
Why two NDCs? The FDA registers this code as 70275-936-16 — 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 → 70275-0936-16. 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 Antiinfectives class.

Drug family (ATC) Antiinfectives, Quaternary ammonium compounds, Medicated dressings with antiinfectives
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

LabelerForward Science Technologies LLC
Labeler code70275
First marketedApr 2021
Product typeHuman Otc Drug
Portfolio3 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?

TheraStom is a dental rinse containing cetylpyridinium chloride, an antimicrobial agent that is commonly used in mouth rinses to help reduce bacteria in the mouth. This product is marketed as an unapproved over-the-counter drug without an approved FDA application. Cetylpyridinium chloride is typically included in oral rinses intended to address gingivitis and plaque formation, though this particular product listing has not undergone FDA review.

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.

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.

💲 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.
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 Total Active Prevention Peppermint 15 mg/20mL 35000-0279-16 COLGATE 500 ml FDA listed
Colgate Total Active Prevention Spearmint 15 mg/20mL 35000-0280-16 Colgate-Palmolive 500 ml FDA listed
Colgate Total Active Prevention Gum Health 15 mg/20mL 35000-0281-16 Colgate-Palmolive 500 ml FDA listed
Hello Clean Mint with aloe vera 15 mg/20mL 35000-0510-12 Colgate-Palmolive 520 ml FDA listed
Hello Extra Minty with extra cooling 15 mg/20mL 35000-0511-12 Colgate-Palmolive 520 ml FDA listed
Hello Peace Out Plaque peace out, plaque antigingivitis 15 mg/20mL 35000-0683-10 Colgate-Palmolive 473 ml FDA listed
Hello empower mint 15 mg/20mL 35000-0690-10 Colgate-Palmolive 473 ml FDA listed
Colgate Total Advanced Pro-Shield Peppermint Blast 15 mg/20mL 35000-0720-02 Colgate-Palmolive 60 ml FDA listed
Colgate Total Advanced Gum Health Mouthwash .75 mg/mL 35000-0723-02 Colgate-Palmolive 60 ml Discontinued
Colgate Total 12 Hr Pro-Shield Spearmint Surge 15 mg/20mL 35000-0731-02 Colgate-Palmolive 60 ml FDA listed
Hello Peace Out Plaque 15 mg/20mL 44038-0683-01 Accupac 473 ml FDA listed
TheraStom .075 mg/.1mLthis 70275-0936-16 Forward 473 ml FDA listed
AHLO PRO Healthy Gums .075 g/100mL 87594-0100-00 Gervest 473 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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
70275-0936-16 You're viewing this 473 mL in 1 BOTTLE (70275-936-16) 2021-04-05 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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 — Not published for this NDC No photo available yet for this listing.
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 "Unapproved Drug Other". 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 70275-936-16, 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: 70275-0936-16, written without dashes as 70275093616. 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 70275-0936-16, the first segment (70275) is the labeler code FDA assigned to Forward Science Technologies LLC; the middle segment (0936) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Forward Science Technologies LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Forward Science Technologies 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.

📄 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 21 words

Use(s) • Helps control plaque that leads to bleeding gums. • Helps prevent gingivitis, an early form of gum disease .

⏱️ Dosage and Administration 22 words

Dosage Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out.

⚠️ Warnings 53 words

Warnings Stop use and ask a dentist if: • Gingivitis, bleeding, or redness persists for more than 2 weeks • You have painful or swollen gums, pus from the gum line, loose teeth, or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

🧪 Active Ingredient 5 words

Active Ingredient Cetylpyridinium Chloride 0.075%

🧪 Inactive Ingredients 18 words

Inactive Ingredients Calcium Disodium EDTA, Flavor (Peppermint, Eucalyptus, Pink Grapefruit), Glycerin, PEG-40, Propylene Glycol, Water, Xylitol, Zinc Gluconate

🎯 Purpose 2 words

Purpose Antigingivitis/Antiplaque

💬 Information for Patients 12 words

Other information This rinse is not intended to replace brushing or flossing

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