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Orajel 4X Medicated Toothache and Gum PM Cream Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride 200 mg/g; .2 mg/g; 1.5 mg/g; 2.6 mg/g Cream — NDC 10237-0889-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Orajel 4X Medicated Toothache and Gum PM Cream Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride 200 mg/g; .2 mg/g; 1.5 mg/g; 2.6 mg/g Cream — NDC 10237-889-25 (Billing 10237-0889-25)

by Church & Dwight Co., Inc. · 1 TUBE in 1 CARTON / 7 g in 1 TUBE

This is a package of Orajel 4X Medicated Toothache and Gum PM Cream Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride 200 mg/g; .2 mg/g; 1.5 mg/g; 2.6 mg/g Cream from Church & Dwight Co., Inc., marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 10237-0889-25
🏷️ FDA NDC (as labeled) 10237-889-25 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 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 10237-889-25 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
10237 labeler · 889 product · 25 package
Package marketed since
Aug 31, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0310310318543
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10237-889-25
Product NDC 10237-889
11-digit billing NDC 10237088925
RxCUI 2751338
UNII U3RSY48JW5, F5UM2KM3W7, 86Q357L16B, L7T10EIP3A
UPC 0310310318543
Application # M022
SPL Set ID 5a1cdaf4-3388-280c-e063-6294a90ac70f
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 2026-08-31
Route TOPICAL
Dosage form CREAM
Substance BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 2751338
Why two NDCs? The FDA registers this code as 10237-889-25 — 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 → 10237-0889-25. 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

🧪 What is this product?

Orajel 4X Medicated Toothache and Gum PM Cream is a topical over-the-counter product marketed under FDA's monograph rules for oral pain-relief creams. It contains benzocaine, a local anesthetic typically used to numb minor mouth and gum discomfort. The formulation also includes benzalkonium chloride, which functions as an antimicrobial agent, along with menthol and zinc chloride, which are commonly included in oral care products for their soothing and astringent properties. This cream is applied directly to affected gum and tooth areas.

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
10237-0889-25 You're viewing this Main listing 1 TUBE in 1 CARTON / 7 g in 1 TUBE 2026-08-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Orajel 4X Medicated Toothache and Gum PM Cream 200 mg/g; .2 mg/g; 1.5 mg/g; 2.6 mg/gthis 10237-0889-25 Church 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 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 FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII 09179OX7TB
    PEG-75 Lanolin is a waxy substance derived from sheep's wool that has been chemically modified to mix easily with water and oil. It acts as an emulsifier and moisturizer in topical formulations, helping blend different ingredients and soften the skin.
  • 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 7QY1MH15BG
    A synthetic organic compound used as a flavoring agent in medicines. It provides a mild, pleasant taste to mask bitter drug flavors and improve patient acceptance of oral formulations.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, raspberry ketone, sodium saccharin, sorbic acid, titanium dioxide, 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

LabelerChurch & Dwight Co., Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code10237
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio156 products on file

More NDCs from Church & Dwight Co., Inc. labeler code 10237

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 34 words ▾

Uses first aid to help prevent infection in minor oral irritation 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 53 words ▾

Directions adults and children 3 years of age and older apply to affected area up to 4 times daily or as directed by a dentist or doctor children between 3 and 12 years of age should be supervised in the use of this product children under 3 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 12 words ▾

Active Ingredients Benzalkonium chloride 0.02% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients ammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, raspberry ketone, sodium saccharin, sorbic acid, titanium dioxide, water

🎯 Purpose 8 words ▾

Purpose Oral antiseptic, Oral pain reliever, Oral astringent

📄 Do Not Use 27 words ▾

Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 3 years of age

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a 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 27 words ▾

Keep out of reach of children If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 30 words ▾

Other information do not use if Tamper-Evident Tab is open before first use avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

📄 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 59 words ▾

Principal Display Panel #1 ORAL PAIN RELIEF BRAND FOR ADULTS OUR MAXIMUM STRENGTH Orajel 4X MEDICATED TOOTHACHE & GUM NIGHTTIME FORMULA with Chamomile IMMEDIATE RELIEF OF SEVERE PAIN Provides Long-Lasting Pain Relief* Helps Prevent Infection & Kills Harmful Bacteria Relieves Throbbing Pain Delivers Targeted Pain Relief ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT NET WT

0.25OZ (7.0 g) Orajel 4X PM CREAM

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 Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride — the ingredient across all brands.

Top reported reactions

Dizziness4
Asthenia3
Dry Mouth2
Dyspnoea2
Fatigue2
Gingival Pain2
Oral Pain2

Age at onset

Adult4
Elderly1

Reporter sex

9 reports

Serious outcomes

Hospitalization1
Death1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 6 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) ✓ 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.
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.
← 10237-0888-33 · Church 10237-0914-42 · 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.