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Ora YoGu 4X Medicated Tooth and Gum Pain Reliever 20 g/100mL; .13 g/100mL; .26 g/100mL; .15 g/100mL Gel — NDC 87351-0761-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ora YoGu 4X Medicated Tooth and Gum Pain Reliever 20 g/100mL; .13 g/100mL; .26 g/100mL; .15 g/100mL Gel — NDC 87351-761-10 (Billing 87351-0761-10)

by Kungpo Health Care & Herbal Center Inc · 1 TUBE in 1 PACKAGE / 10 mL in 1 TUBE

This is a package of Ora YoGu 4X Medicated Tooth and Gum Pain Reliever 20 g/100mL; .13 g/100mL; .26 g/100mL; .15 g/100mL Gel from Kungpo Health Care & Herbal Center Inc, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 87351-0761-10
🏷️ FDA NDC (as labeled) 87351-761-10 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 87351-761-10
Product NDC 87351-761
11-digit billing NDC 87351076110
UNII U3RSY48JW5, F5UM2KM3W7, L7T10EIP3A, 86Q357L16B
Application # M022
SPL Set ID 1f10a72f-0b49-41cb-92f9-b0160d7664de
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-15
Route TOPICAL
Dosage form GEL
Substance BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL; ZINC CHLORIDE
Why two NDCs? The FDA registers this code as 87351-761-10 — 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 → 87351-0761-10. 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

🧪 What is this product?

Ora YoGu 4X is a topical gel for tooth and gum pain relief marketed as an over-the-counter monograph product. It contains benzocaine, a local anesthetic typically used to numb pain, and menthol, which produces a cooling sensation often used in pain-relief products. The formulation also includes benzalkonium chloride, commonly used as an antimicrobial agent, and zinc chloride, which appears in various oral care products. This gel is applied directly 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.

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.
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
87351-0761-10 You're viewing this Main listing 1 TUBE in 1 PACKAGE / 10 mL in 1 TUBE 2026-04-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever 20 g/100mL; .13 g/100mL; .26 g/100mL; .15 g/100mLthis 87351-0761-10 Kungpo 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

🏛️
2026
On the market since
Apr 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.

What it looks like

Color white
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5S29HWU6QB
    Cinnamon is a spice derived from tree bark. It's used in medicines as a flavoring agent to improve taste and mask unpleasant flavors, making the medicine easier to take.
  • UNII VD727WIZ56
    A plant extract from cyperus rotundus, traditionally used in herbal medicine. In formulations, it may serve as a flavoring agent, natural colorant, or functional ingredient to support the product's intended properties.
  • UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.
  • UNII SA1B764746
    A synthetic polymer commonly used as a solvent and binder in medicines. It helps dissolve active ingredients, improve texture, and ensure consistent tablet or capsule formation.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII HJT620308C
    A mineral compound used to replace sodium chloride in formulations. It serves as a filler and flavor enhancer while reducing sodium content in the medicine.
  • UNII MO9DK65G18
    A plant extract from schisandra berries used in traditional Asian medicine. In formulations, it may serve as a botanical ingredient to support the product's intended properties or as a natural flavoring agent.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.

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

The official label also statesPOLYETHYLENE GLYCOL 300, POLYETHYLENE GLYCOL 3000, SACCHARIN SODIUM, SORBIC ACID, CINNAMON, SALT SUBSTITUTE, SCHISANDRA CHINENSIS SEED, CYPERUS ROTUNDUS FRUIT

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.

Manufacturer & labeler

LabelerKungpo Health Care & Herbal Center Inc
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code87351
First marketedApr 2026
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.

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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses Temporarily relieves pain caused by minor oral and gum injuries. First aid to help prevent infection from minor oral irritations. Improves loose teeth and maintains dental health.

⏱️ Dosage and Administration 87 words ▾

Directions Adult and children 2 years of age and over - Apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children between 2 and 12 years of age - Ask a doctor before use. Should be supervised in using this product. Children under 2 years of age - Do not use. Do not use if Amper-Evident Tab is open before first use. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

⚠️ Warnings 35 words ▾

Warning Use of this product may cause methemoglobinemia, a serious condition that requires immediate treatment because it reduces the oxygen-carrying capacity of the blood. This can happen even if you have used this product before.

🧪 Active Ingredient 12 words ▾

Active ingredients Benzalkonium Chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc Chloride 0.15%

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients POLYETHYLENE GLYCOL 300, POLYETHYLENE GLYCOL 3000, SACCHARIN SODIUM, SORBIC ACID, CINNAMON, SALT SUBSTITUTE, SCHISANDRA CHINENSIS SEED, CYPERUS ROTUNDUS FRUIT

🎯 Purpose 15 words ▾

Purpose Benzalkonium Chloride Oral Antibacterial Benzocaine Oral Antibacterial Menthol Oral Antibacterial Zinc Chloride Oral Antibacterial

📄 Do Not Use 43 words ▾

Do not use Do not use this product if you have a history of allergy to procaine, butacaine, benzocaine, or other "caine" class local anesthetics. Do not exceed the recommended dosage for more than 7 days unless directed by a dentist or doctor.

📄 Stop Use and Ask a Doctor If 65 words ▾

Stop use and ask a doctor if Stop use and seek immediate medical attention if you or child in your care develops: Pale, gray, or blue colored skin (cyanosis) Headache Rapid heart rate Shortness of breath Dizziness or lightheadedness Fatigue or lack of energy Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain, or redness persists or worsens.

📄 Keep Out of Reach of Children 24 words ▾

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a poison Control Center right away.

📄 Other Information 38 words ▾

Other information This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. Do not use if Temper-Evident Tab is open before first use.

📄 Package Label / Principal Display Panel 2 words ▾

image description

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) ✓ 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 Kungpo Health Care & Herbal Center Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kungpo Health Care & Herbal Center Inc 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.
87352-0001-01 · Easment →
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.