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(from DailyMed)

Toothache Polyhexamethylene Biguanide Hydrochloride .25 g/100mL Spray, 30 mL

by Guchutang Biotechnology (Longyan) Co., Ltd · 30 mL in 1 BOTTLE (87083-012-01)
NDC 87083-0012-01
🏷️ FDA NDC (as labeled) 87083-012-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 87083-012-01
Product NDC 87083-012
11-digit billing NDC 87083001201
UNII 4XI6112496
Application # M022
SPL Set ID 54ad2ceb-272f-e5ba-e063-6394a90aec5f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-20
Route TOPICAL
Dosage form SPRAY
Substance POLIHEXANIDE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 87083-012-01 — 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 → 87083-0012-01. 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.

🏭 Manufacturer & labeler

LabelerGuchutang Biotechnology (Longyan) Co., Ltd
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code87083
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio9 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?

This is a topical spray product marketed as an over-the-counter toothache remedy under FDA's OTC monograph rules. The active ingredient, polihexamethylene biguanide hydrochloride (also called polihexanide), is an antimicrobial agent typically used in oral care products to help reduce bacteria in the mouth. This spray formulation is intended for direct application to the affected tooth or gum area.

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.

🧪 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 01Q9PC255D
    Ammonium chloride is a white crystalline salt used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level of a product to keep the active ingredient stable and effective.
  • UNII 3J5I6254YO
    A plant-derived ingredient from watermelon fruit. Used in formulations as a natural filler and texturizer to add bulk and consistency to the medicine.
  • UNII 26LKE578NY
    A natural plant extract from the thorns of the Chinese honey locust tree. It's used in formulations as a binder and thickening agent to help hold ingredients together and adjust product texture.
  • 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 5N1WD9784U
    A plant-derived ingredient from honeysuckle flowers, used as a natural flavoring or fragrance component to improve taste or aroma in the medicine.
  • UNII 6Y8XYV2NOF
    A waxy substance made by honeybees from plant resins and pollen. In medicines, it acts as a binder and coating agent to hold ingredients together and protect the product.
  • UNII 9DE5YCO0RU
    A plant extract from dandelion root traditionally used in herbal preparations. In medications, it may serve as a flavor enhancer, natural colorant, or bitter component that supports formulation taste and appearance.
  • 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 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.

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

The official label also statesWatermelon Frost, Honeysuckde Extract, Propolis Extract, Dandelion Extract, Gleditsia Sinensis Thorn Extract, Honeysuckle Stem Extract, Glycerol (Glycerin), xylitol, Food Grade Flavor Essence, Ammonium Chloride, Purified Water,

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 mLPer 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
Toothache .25 g/100mLthis 87083-0012-01 Guchutang 30 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
87083-0012-01 You're viewing this 30 mL in 1 BOTTLE (87083-012-01) 2026-06-20 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 — Not published for this NDC No photo available yet for this listing.
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 87083-012-01, 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: 87083-0012-01, written without dashes as 87083001201. 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 87083-0012-01, the first segment (87083) is the labeler code FDA assigned to Guchutang Biotechnology (Longyan) Co., Ltd; the middle segment (0012) 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 Guchutang Biotechnology (Longyan) Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guchutang Biotechnology (Longyan) Co., Ltd 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 21 words ▾

if you are pregnant, breastfeeding, an infant or young child, or if you have an allergy to any ingredientof this product.

⏱️ Dosage and Administration 18 words ▾

Spray directlyon the mouth (toothache) for discomfort, 1-3 sprays each time, 2-3 times a day or as needed.

⚠️ Warnings 45 words ▾

1. This product isnot food, medicine or medical device. Do nottake orally. Keep out 2. If local irritation or discomfort occurs while using this product, please consult a 3. This is a health care product and cannot replace medicines or medical devices for treating diseases.

🧪 Active Ingredient 7 words ▾

Activeingredient.... .Purpose Polyhexamethylene Biguanide Hydrochloride 0.25% Antibacterial

🧪 Inactive Ingredients 26 words ▾

Watermelon Frost, Honeysuckde Extract, Propolis Extract, Dandelion Extract, Gleditsia Sinensis Thorn Extract, Honeysuckle Stem Extract, Glycerol (Glycerin), xylitol, Food Grade Flavor Essence, Ammonium Chloride, Purified Water,

🎯 Purpose 15 words ▾

Topical care for dental sufferers; relieves halitosis, periodontal & gum discomfort, aids gum repair &conditioning.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87083-0011-01 · Guchutang 87084-5942-01 · Guangzhou →
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.