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Orajel Gum Pain 3X Medicated benzocaine, menthol, zinc chloride 200 mg/g; 1.5 mg/g; 2.6 mg/g Gel, 1 tube — NDC 10237-0792-42 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Orajel Gum Pain 3X Medicated benzocaine, menthol, zinc chloride 200 mg/g; 1.5 mg/g; 2.6 mg/g Gel, 1 tube — NDC 10237-792-42 (Billing 10237-0792-42)

by Church & Dwight Co., Inc. · 1 TUBE in 1 CARTON / 11.9 g in 1 TUBE

This is a package of 1 tube of Orajel Gum Pain 3X Medicated benzocaine, menthol, zinc chloride 200 mg/g; 1.5 mg/g; 2.6 mg/g Gel from Church & Dwight Co., Inc., marketed since Dec 2019 and currently FDA-listed.

NDC 10237-0792-42
🏷️ FDA NDC (as labeled) 10237-792-42 billing pads the product segment with a zero
This package
Contains1 tube Pack sizes2 compare ↓
Product page 10237-0792-12 Also comes in: 3.5 g 10237-792-12
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) 10237-792-42
Product NDC 10237-792
11-digit billing NDC 10237079242
RxCUI 2362013
UNII U3RSY48JW5, 86Q357L16B, L7T10EIP3A
Application # M022
SPL Set ID 9a1632ad-2b47-5653-e053-2995a90ae0d9
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 2019-12-17
Route TOPICAL
Dosage form GEL
Substance BENZOCAINE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 2362013
Why two NDCs? The FDA registers this code as 10237-792-42 — 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 → 10237-0792-42. 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?

Orajel Gum Pain 3X is a topical gel marketed as an over-the-counter oral pain reliever under FDA's OTC monograph rules. It contains benzocaine, a local anesthetic typically used to numb minor mouth and gum pain, along with menthol, which is commonly included for a cooling sensation. The product also includes zinc chloride, which is typically used in oral care products for its astringent properties. This gel is applied directly to the affected gum area to provide temporary relief from minor pain.

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: 3.5 g
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
10237-0792-12 10237-792-12 Main listing 1 TUBE in 1 PACKAGE / 3.5 g in 1 TUBE 2019-12-17 — Active
10237-0792-42 You're viewing this 1 TUBE in 1 CARTON / 11.9 g in 1 TUBE 2019-12-17 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 11.9 g in 1 tube.
How does this package differ from NDC 10237-0792-12?
Both are Orajel Gum Pain 3X Medicated benzocaine, menthol, zinc chloride 200 mg/g; 1.5 mg/g; 2.6 mg/g Gel — the drug itself is identical. This page's package is the 1 tube one, while NDC 10237-0792-12 is the 1 tube package.
What NDC number is used to bill for this package of Orajel Gum Pain 3X Medicated benzocaine, menthol, zinc chloride 200 mg/g; 1.5 mg/g; 2.6 mg/g 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
Orajel Rescue Relief Pen 1.5 mg/g; 2.6 mg/g; 200 mg/g 10237-0731-07 Church 1 applicator — — FDA listed —
Orajel 3X Medicated For Toothache and Gum 2.6 mg/g; 200 mg/g; 1.5 mg/g 10237-0790-12 Church 1 tube — — FDA listed —
Orajel Gum Pain 3X Medicated 200 mg/g; 1.5 mg/g; 2.6 mg/gthis 10237-0792-42 Church 1 tube — — FDA listed —
3X Medicated Toothache and Gum Gel 20 g/100g; .26 g/100g; .15 g/100g 11822-0613-09 Rite 1 tube — — FDA listed —
DG 3x Medicated Toothache adn Gum Gel 20 g/100g; .15 g/100g; .26 g/100g 55910-0816-69 Dollar 1 tube — — FDA listed —
3x Medicated Toothache and Gum Gel 20 g/100g; .26 g/100g; .15 g/100g 69842-0693-39 CVS 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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerChurch & Dwight Co., Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code10237
First marketedDec 2019
Product typeHuman Otc Drug
Portfolio156 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

⏱️ Dosage and Administration 58 words ▾

Directions Adults and children 2 years of age and older 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 the use of this product Children under 2 years of age Do not use

⚠️ Warnings 105 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 9 words ▾

Active ingredients Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water

🎯 Purpose 7 words ▾

Purpose Oral pain reliever and Oral astringent

📄 Do Not Use 30 words ▾

Do not use

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

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop use and ask a doctor if 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 13 words ▾

Other information do not use if Tamper-Evident Tab is open before first use

📄 Questions or Comments 16 words ▾

Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

📄 Package Label / Principal Display Panel 44 words ▾

Principal Display Panel #1 ORAL PAIN RELIEVER BRAND FOR ADULTS Open Tube Tip Orajel GUM PAIN 3X MEDICATED GEL INSTANT PAIN RELIEF 20% Benzocaine to Relieve Gum Pain Cooling Relief to Soothe Gums Relieves Gum Irritation ORAL PAIN RELIEVER/ASTRINGENT NET WT 0.125oz (3.5g) CR2_DA2044058_OJFC-00500-01_72016656

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Orajel Gum Pain 3X Medicated (this brand).

Top reported reactions

Accidental Exposure To Product By Child1
Accidental Overdose1
Cyanosis1
Fatigue1
Methaemoglobinaemia1
Oxygen Saturation Decreased1
Pallor1

Reporter sex

1 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 0
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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Church & Dwight Co., Inc.. 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 tube (10237-0792-12). 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?
Church & Dwight Co., 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.
← 10237-0790-12 · Church 10237-0796-45 · Church →
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.