NDC 10237-0731-07 — Orajel Rescue Relief Pen Oral Pain Reliever

🆔 Identity & classification

FDA NDC (as labeled) 10237-731-07

Product NDC 10237-731

11-digit billing NDC 10237073107

RxCUI 2362013

UNII 86Q357L16B, L7T10EIP3A, U3RSY48JW5

Application # M022

SPL Set ID 2d68eec5-ae8a-9cdf-e063-6294a90a9799

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 2025-02-01

Route ORAL

Dosage form GEL

Substance ZINC CHLORIDE; MENTHOL; BENZOCAINE

Why two NDCs? The FDA registers this code as 10237-731-07 — 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 → 10237-0731-07. 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

LabelerChurch & Dwight Co., Inc.

FDA applicationM022 (OTC MONOGRAPH DRUG)

Labeler code10237

First marketedFeb 2025

Product typeHuman Otc Drug

Portfolio156 products on file

🔎 All NDCs from Church & Dwight Co., Inc.

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?

Orajel Rescue Relief Pen is an over-the-counter oral gel marketed under FDA's OTC monograph rules for oral pain relievers. It combines benzocaine, a local anesthetic typically used to numb minor mouth pain, with menthol, which is commonly included for a cooling sensation. The formulation also contains zinc chloride. This product is applied directly to the mouth and gums to help relieve discomfort from minor oral irritations, sores, or dental pain.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color yellow

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 3VRD35U26C
A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
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.
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.

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

The official label also statesammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, 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.

💲 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 system	Per g	Per 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: 2 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Orajel Rescue Relief Pen 1.5 mg/g; 2.6 mg/g; 200 mg/gthis 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/g 10237-0792-12	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

🏛️

2025

On the market since

Feb 2025

📍

2026

Currently FDA-listed

1 year 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
10237-0731-07 You're viewing this	1 APPLICATOR in 1 BLISTER PACK (10237-731-07) / 2 g in 1 APPLICATOR	2025-02-01	Active
10237-0731-27	2 BLISTER PACK in 1 PACKAGE (10237-731-27) / 1 APPLICATOR in 1 BLISTER PACK / 2 g in 1 APPLICATOR	2025-06-01	Active

Pack size FAQ

What quantity is in NDC 10237-0731-07?

NDC 10237-0731-07 is listed by the FDA — 1 applicator in 1 blister pack / 2 g in 1 applicator.

What NDC number is used to bill for this package of Orajel Rescue Relief Pen Oral Pain Reliever 1.5 mg/g; 2.6 mg/g; 200 mg/g Gel?

Bill NDC 10237-0731-07 — the 11-digit billing format is 10237073107. 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	— Not published for this NDC No photo available yet for this listing.
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 FDA registers it as 10237-731-07, 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: 10237-0731-07, written without dashes as 10237073107. 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 10237-0731-07, the first segment (10237) is the labeler code FDA assigned to Church & Dwight Co., Inc.; the middle segment (0731) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 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 applicator (10237-0731-27). 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.

📄 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 27 words ▾

USES • for the temporary relief of • pain due to minor irritation or injury of the mouth and gums • occasional sore mouth and sore throat

⏱️ Dosage and Administration 59 words ▾

DIRECTIONS adults and children 2 years of age and older apply to the 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 210 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 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 DENTIST OR DOCTOR IF • sore throat is severe, persists for more than 2 days • sore mouth symptoms do not improve in 7 days • headache, nausea, vomiting, swelling, rash or fever develops • irritation, pain or redness persists or worsens KEEP OUT OF REACH OF CHILDREN In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENTS Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

🧪 Inactive Ingredients 12 words ▾

INACTIVE INGREDIENTS ammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water

🎯 Purpose 7 words ▾

PURPOSE Oral Pain Reliever / Oral Astringent

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

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