Home › NDC Lookup › Ingredients › Benzocaine 20%, Benzalkonium Chloride 1% › 83324-0035-12
Quality Choice Oral Pain Relief Benzocaine 20%, Benzalkonium Chloride 1% 200 mg/g; 10 mg/g Gel, 1 tube — NDC 83324-0035-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Quality Choice Oral Pain Relief Benzocaine 20%, Benzalkonium Chloride 1% 200 mg/g; 10 mg/g Gel, 1 tube — NDC 83324-035-12 (Billing 83324-0035-12)

by Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) · 1 TUBE in 1 CARTON / 11.9 g in 1 TUBE

This is a package of 1 tube of Quality Choice Oral Pain Relief Benzocaine 20%, Benzalkonium Chloride 1% 200 mg/g; 10 mg/g Gel from Quality Choice (CHAIN DRUG MARKETING ASSOCIATION), marketed since Apr 2024 and currently FDA-listed. It is this product's only package size.

NDC 83324-0035-12
🏷️ FDA NDC (as labeled) 83324-035-12 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 83324-035-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83324 labeler · 035 product · 12 package
Package marketed since
Apr 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8332403512 6
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83324-035-12
Product NDC 83324-035
11-digit billing NDC 83324003512
UNII U3RSY48JW5, F5UM2KM3W7
Application # M022
SPL Set ID 162702b4-4bf7-8868-e063-6294a90a5921
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 2024-04-01
Route TOPICAL
Dosage form GEL
Substance BENZOCAINE; BENZALKONIUM CHLORIDE

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

GCN Seq No 086791
GCN 56559
HICL code 001134
Ingredient (HICL) Benzocaine/Benzalk Chl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0A
Therapeutic class — specific (HIC3) Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name QC ORAL PAIN RLF 20%-0.1% GEL
FDB brand name Oral Pain Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 086791
  • GCN: 56559
  • HICL (First Databank): 001134
  • AHFS class code: 52:16.00.00
Why two NDCs? The FDA registers this code as 83324-035-12 — 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 → 83324-0035-12. 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 QC ORAL PAIN RLF 20%-0.1% GEL Ingredient Benzocaine/Benzalk Chl
🧪 What is this product?

Quality Choice Oral Pain Relief is a topical gel containing benzocaine and benzalkonium chloride. Benzocaine is a local anesthetic typically used to numb minor mouth and throat irritation, while benzalkonium chloride functions as an antimicrobial preservative. This product is marketed as an over-the-counter monograph drug, meaning it is sold under FDA's established rules for this category of oral pain relief products rather than as an individually reviewed application.

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
83324-0035-12 You're viewing this Main listing 1 TUBE in 1 CARTON / 11.9 g in 1 TUBE 2024-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oral Pain Relief .2 g/g; .01 g/g 52000-0060-01 Universal 1 tube — — Discontinued —
Quality Choice Oral Pain Relief 200 mg/g; 10 mg/gthis 83324-0035-12 Quality 1 tube — — FDA listed —
Oral Gel Oral Pain Relief 20 g/100g; .1 g/100g 83650-0101-01 Savvy 42.5 g — — 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.

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 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 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.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • 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.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesglycerin, PEG 400, propylene glycol, sorbitol, sodium saccharine, sorbic acid, sodium polyacrylate,strawberry flavor, 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.

Manufacturer & labeler

LabelerQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio91 products on file

More NDCs from Quality Choice (CHAIN DRUG MARKETING ASSOCIATION... labeler code 83324

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 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Use for the temporary relief of pain due to toothaches to help protect against infection in minor oral irritation

⏱️ Dosage and Administration 67 words ▾

Directions Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider Children under 12 years of age - Should be supervised in the use of this product Children under 2 years of age -do not use

⚠️ Warnings 109 words ▾

Warnings Methemoglobinemia warning : use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a 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 Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

🧪 Active Ingredient 7 words ▾

Active ingredients Benzocaine 20% Benzalkonium Chloride 0.1%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients glycerin, PEG 400, propylene glycol, sorbitol, sodium saccharine, sorbic acid, sodium polyacrylate,strawberry flavor, water

🎯 Purpose 5 words ▾

Purpose Oral pain reliever Antiseptic

📄 Do Not Use 28 words ▾

Do not use more than directed for more than 7 days unless directed by a physician or healthcare provider for teething in children under 2 years of age

📄 Ask a Doctor Before Use If 26 words ▾

Stop use and ask a physician if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days

📄 Keep Out of Reach of Children 25 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 (1-800-222-1222)

📄 Other Information 58 words ▾

Other information this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted do not use continuously avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying do not use if tube seal under cap is broken store at 20-25C (68-77F)

📄 Questions or Comments 6 words ▾

Questions or comments? TOLL FREE 800-935-2362

📄 Package Label / Principal Display Panel 1 words ▾

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 Quality Choice (CHAIN DRUG MARKETING ASSOCIATION). Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) 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.
← 83324-0034-04 · QUALITY 83324-0036-01 · Chain →
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.