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Dental Relief benzocaine 200 mg/g Liquid, 10 packets — NDC 68421-8100-03 package photo

Dental Relief benzocaine 200 mg/g Liquid, 10 packets

by Cintas First Aid & Safety · 10 PACKET in 1 BAG (68421-8100-3) / .5 g in 1 PACKET (68421-8100-2)
NDC 68421-8100-03
🏷️ FDA NDC (as labeled) 68421-8100-3 billing pads the package segment with a zero
This package
Contains10 packets Pack sizes2 compare ↓
Also comes in: 500 packets 68421-8100-04
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

⚠️
Other active recalls for Benzocaine (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68421-8100-3
Product NDC 68421-8100
11-digit billing NDC 68421810003
RxCUI 308657
UNII U3RSY48JW5
Application # part356
SPL Set ID d9068a54-6123-4715-b025-a5bdb4d5c702
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 NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-05-06
Route TOPICAL
Dosage form LIQUID
Substance BENZOCAINE
Why two NDCs? The FDA registers this code as 68421-8100-3 — a 5-4-1 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 package segment → 68421-8100-03. 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.

🏭 Manufacturer & labeler

LabelerCintas First Aid & Safety
FDA applicationpart356 (OTC MONOGRAPH NOT FINAL)
Labeler code68421
First marketedMay 2016
Product typeHuman Otc Drug
Portfolio2 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?

Dental Relief is a topical liquid containing benzocaine, a local anesthetic commonly used to temporarily numb minor mouth and gum discomfort. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this category of oral anesthetic products rather than through an individual application review. Benzocaine works by reducing nerve signals in the area where it is applied, and such products are typically used for temporary relief of minor dental pain or irritation.

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzocaine — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzocaine (3 interactions) — ranked by severity →
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 AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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.
  • 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 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 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.

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

The official label also statesPEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

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.
Try another pack size: 500 packets
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
Benzocaine 20% 200 mg/mL 00121-1077-25 PAI 25 pouches — — FDA listed —
HurriCaine Topical Anesthetic Liquid 200 mg/g 00283-0569-02 Beutlich 2 g — — Discontinued —
HurriCaine Topical Anesthetic Liquid 200 mg/g 00283-1886-17 Beutlich 1 g — — FDA listed —
Walgreens Mouth Sore Relief 200 mg/mL 00363-5334-00 Walgreens 1 bottle — — FDA listed —
Walgreens Maximum Strength 20 g/100g 00363-5820-58 Walgreens 1 bottle — — FDA listed —
Kank-A Mouth Pain 200 mg/mL 10157-9477-01 Blistex 9.75 ml — — FDA listed —
Red Cross Oral Pain Relief 200 mg/mL 10742-8902-01 The 1 bottle — — FDA listed —
Rite Aid Maximum Strength 20 g/100g 11822-0345-09 Rite 1 bottle — — FDA listed —
Rite Aid Professional Strength 20 g/100g 11822-5340-08 Rite 1 bottle — — FDA listed —
Topcare Maximum Strength 20 g/100g 36800-0443-48 Topco 1 bottle — — FDA listed —
Dental Relief 200 mg/g 42961-0810-03 Cintas 10 packets — — FDA listed —
Rexall Maximum Strength 20 g/100mL 55910-0346-79 Rexall 1 bottle — — FDA listed —
CVS Pharmacy Maximum Strength 20 g/100g 59779-0743-89 CVS 1 bottle — — FDA listed —
Mouth Sore Relief Professional Strength 200 mg/g 59779-0830-38 CVS 1 bottle — — FDA listed —
DenTek Instant Pain Relief Maximum Strength 200 mg/mL 60630-0078-01 DenTek 1 vial — — FDA listed —
Dental Relief 200 mg/gthis 68421-8100-03 Cintas 10 packets — — FDA listed —
Anesgerm LA MUELA Fast Pain Relief 200 mg/mL 73635-7101-05 Germa 1 bottle — — Discontinued —
Oral Anesthetic Liquid 20 g/100g 79481-0118-09 Meijer, 1 bottle — — FDA listed —
Anbesol Maximum Strength 200 mg/mL 80070-0230-41 Foundation 1 bottle — — FDA listed —
Pain Relief 200 mg/g 61010-8100-01 Safetec 144 packets — — 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

🏛️
2016
On the market since
May 2016
📍
2026
Currently FDA-listed
10 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dental Relief (this brand).

Top reported reactions

Methaemoglobinaemia124
Drug Hypersensitivity61
Asthenia48
Nausea46
Dyspnoea38
Arthralgia36
Anxiety35

Reporter sex

756 reports
Male · 35%
Female · 65%
Unknown · 1%

Serious outcomes

Hospitalization309
Death68
Disabling50
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 48 4
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68421-8100-03 You're viewing this 10 PACKET in 1 BAG (68421-8100-3) / .5 g in 1 PACKET (68421-8100-2) 2016-05-06 Active
68421-8100-04 500 PACKET in 1 BOX (68421-8100-4) / .5 g in 1 PACKET (68421-8100-2) 2016-05-06 Active

Pack size FAQ

What quantity is in NDC 68421-8100-03?
NDC 68421-8100-03 contains 10 packets — 10 packet in 1 bag / .5 g in 1 packet.
What is the difference between NDC 68421-8100-03 and NDC 68421-8100-04?
Both are Dental Relief benzocaine 200 mg/g Liquid — the drug itself is identical. NDC 68421-8100-03 is the 10 packets package, while NDC 68421-8100-04 is the 500 packets package.
What NDC number is used to bill for this package of Dental Relief benzocaine 200 mg/g Liquid?
Bill NDC 68421-8100-03 — the 11-digit billing format is 68421810003. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 Not Final". 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 68421-8100-3, 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: 68421-8100-03, written without dashes as 68421810003. 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 68421-8100-03, the first segment (68421) is the labeler code FDA assigned to Cintas First Aid & Safety; the middle segment (8100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Cintas First Aid & Safety. 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 500 packets (68421-8100-04). 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?
Cintas First Aid & Safety 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 23 words ▾

Uses For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

⏱️ Dosage and Administration 64 words ▾

Directions Adults and children 2 years and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor Consult a dentist or doctor for use on children under 2 years of age Children under 12 years of should be supervised in the use of this product

⚠️ Warnings 125 words ▾

Warnings For oral use only Allergy alert Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock. When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly.

Do not exceed recommended dosage. Keep out of reach of children. If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients Benzocaine 20% (w/w)

🧪 Inactive Ingredients 12 words ▾

Inactive Ingredients PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

🎯 Purpose 3 words ▾

Purpose Oral antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68421-5100-01 · Cintas 68436-0120-16 · Dextrum →
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.