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GingiCaine Gel, Pina Colada 200 mg Gel, 6-count — NDC 10129-0033-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GingiCaine Gel, Pina Colada 200 mg Gel, 6-count — NDC 10129-033-05 (Billing 10129-0033-05)

by Gingi-Pak a Division of the Belport · 6 GEL in 1 BOTTLE, PLASTIC

This is a package of 6 gels of GingiCaine Gel, Pina Colada 200 mg Gel from Gingi-Pak a Division of the Belport, marketed since Jul 1993 and currently FDA-listed.

NDC 10129-0033-05
🏷️ FDA NDC (as labeled) 10129-033-05 billing pads the product segment with a zero
This package
Contains6-count Pack sizes2 compare ↓
Product page 10129-0033-01 Also comes in: 1 gel 10129-033-01
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) 10129-033-05
Product NDC 10129-033
11-digit billing NDC 10129003305
RxCUI 238910, 543801
UNII U3RSY48JW5
Application # M022
SPL Set ID 6284e1fe-be33-69bf-e053-2991aa0a90ab
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 1993-07-06
Route DENTAL, ORAL, PERIODONTAL
Dosage form GEL
Substance BENZOCAINE
Quick answers
  • RxCUI (RxNorm): 238910
Why two NDCs? The FDA registers this code as 10129-033-05 — 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 → 10129-0033-05. 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 Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
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

🧪 What is this product?

GingiCaine Gel is an over-the-counter oral anesthetic gel marketed under FDA's OTC monograph rules. It contains benzocaine, a local anesthetic that is commonly used to temporarily numb pain and soreness in the mouth and gums. The gel formulation is applied directly to the affected oral or periodontal area. This product is intended for temporary relief of minor mouth and gum discomfort.

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.
Try another pack size: 1 gel
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
10129-0033-01 10129-033-01 Main listing 1 GEL in 1 BOTTLE, PLASTIC 1993-07-06 — Active
10129-0033-05 You're viewing this 6 GEL in 1 BOTTLE, PLASTIC 1993-07-06 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 6-count package — 6 gel in 1 bottle, plastic.
How does this package differ from NDC 10129-0033-01?
Both are GingiCaine Gel, Pina Colada 200 mg Gel — the drug itself is identical. This page's package is the 6-count one, while NDC 10129-0033-01 is the 1 gel package.
What NDC number is used to bill for this package of GingiCaine Gel, Pina Colada 200 mg Gel?
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
GingiCaine Gel, Pina Colada 200 mgthis 10129-0033-05 Gingi-Pak 6 gels — — 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

🏛️
1993
On the market since
Jul 1993
📍
2026
Currently FDA-listed
33 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

Color orange
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.

  • 260 mg UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • 520 mg UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 20 mg UNII 73U34YC90U
    A salt compound made from potassium, sodium, and saccharate used in medicines as a binder and bulking agent to help hold tablet or capsule ingredients together and add volume to the formulation.

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

The official label also statespolyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, FD&C red #40, D&C yellow #10

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

LabelerGingi-Pak a Division of the Belport
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code10129
First marketedJul 1993
Product typeHuman Otc Drug
Portfolio14 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

Uses For anesthesia of mucous membrane of oropharynx. Temporary relief of pain or discomfort caused by • Minor dental procedures • Minor gum injury • canker sores • Sore throat • Minor mouth or gum irritations caused by dentures or orthodontic appliances

⏱️ Dosage and Administration 105 words ▾

Dosage and Adminstration Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa.

Care must be taken to avoid cross–contamination between patients. Total dose should not exceed the amount required for anesthesia. Apply to the affected area.

Remain in place for at least 1 minute and then spit out. • Use up to 4 times a day or as directed by a dentist or doctor. • This product is for adults and children 2 years of age and older.

⚠️ Warnings 152 words ▾

Warnings Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age. For topical use only Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop: • Pale, gray, or blue colored skin (cyanosis) • Headache • Rapid heart rate • Shortness of breath • Dizziness or lightheadedness • Fatigue or lack of energy Stop use and ask a doctor if (signs of toxicity) • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting develops • Mouth sores do not go away in 7 days • Irritation, pain, or redness worsens

📦 Storage and Handling 17 words ▾

Avoid excessive heat DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN. Avoid excessive heat above 40°C (104°F).

🧪 Active Ingredient 5 words ▾

Active Ingredients Benzocaine 20% w/v

🧪 Inactive Ingredients 17 words ▾

Inactive Ingredients polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, FD&C red #40, D&C yellow #10

🎯 Purpose 3 words ▾

Purpose Oral Anesthetic

📄 Do Not Use 53 words ▾

Allergy Alert and Contraindication Do not use if you have a history of allergy to any “Caine” local anesthetics. Avoid contact with eyes. Keep out of reach of children. If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor (pharmacist) Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes.

📄 Keep Out of Reach of Children 31 words ▾

Keep out of reach of children Keep out of reach of children. If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 34 words ▾

Gingicaine Gel, Piña Colada label Manufactured by: Gingi-Pak ® , 4825 Camarillo, CA 93012 www.gingi-pak.com Gingicaine ® Piňa Colada Topical Anesthetic Gel 20% Benzocaine Oral Anesthetic REF 20116 NDC 10129-033-03 1 oz. Jar Label

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 Gingi-Pak a Division of the Belport. 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 gel (10129-0033-01). 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?
Gingi-Pak a Division of the Belport 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.
← 10129-0032-03 · Gingi-Pak 10129-0034-01 · Gingi-Pak →
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.