Home › NDC Lookup › Ingredients › Benzocaine › 00363-0607-19
🧴image loading
(from DailyMed)

4x Medicated Toothache and Gum Cream Benzocaine 20 g/100g; .13 g/100g; .15 g/100g; .26 g/100g Cream — NDC 0363-0607-19 (Billing 00363-0607-19)

by Walgreens · 1 TUBE in 1 CARTON / 14 g in 1 TUBE

This is a package of 4x Medicated Toothache and Gum Cream Benzocaine 20 g/100g; .13 g/100g; .15 g/100g; .26 g/100g Cream from Walgreens, marketed since Jun 2020 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00363-0607-19
🏷️ FDA NDC (as labeled) 0363-0607-19 billing pads the labeler segment with a zero
This package
Contains14 g in 1 tube Pack sizes2 compare ↓
Main listing for product 0363-0607 · Also comes in: 9.4 g 0363-0607-79
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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-0607-19
Product NDC 0363-0607
11-digit billing NDC 00363060719
RxCUI 2370903
UNII U3RSY48JW5, F5UM2KM3W7, 86Q357L16B, L7T10EIP3A
Application # M017
SPL Set ID a71c2092-4ece-b82e-e053-2995a90ac933
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 2020-06-02
Route ORAL
Dosage form CREAM
Substance BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 2370903
Why two NDCs? The FDA registers this code as 0363-0607-19 — a 4-4-2 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 labeler segment → 00363-0607-19. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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?

This is an over-the-counter topical cream marketed under FDA's monograph rules for oral use, intended for application to teeth and gums. The main active ingredient, benzocaine, is a local anesthetic typically used to numb minor mouth pain and discomfort. Benzalkonium chloride functions as an antimicrobial agent, while menthol and zinc chloride are included for their soothing and astringent properties commonly found in oral care products. The cream is not individually reviewed by the FDA but follows established standards for this product category.

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.

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: 9.4 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
00363-0607-79 0363-0607-79 1 TUBE in 1 CARTON / 9.4 g in 1 TUBE 2020-06-02 — Active
00363-0607-19 You're viewing this Main listing 1 TUBE in 1 CARTON / 14 g in 1 TUBE 2024-02-16 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 14 g in 1 tube.
What NDC number is used to bill for this package of 4x Medicated Toothache and Gum Cream Benzocaine 20 g/100g; .13 g/100g; .15 g/100g; .26 g/100g Cream?
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
4x Medicated Toothache and Gum Cream 20 g/100g; .13 g/100g; .15 g/100g; .26 g/100gthis 00363-0607-19 Walgreens 1 tube — — FDA listed —
PM Toothache Relief 20 g/100g; .26 g/100g; .15 g/100g; .13 g/100g 00363-1623-09 Walgreens 1 tube — — FDA listed —
Orajel 4X Medicated For Toothache and Gum, Cream 1.3 mg/g; 200 mg/g; 2.6 mg/g; 1.5 mg/g 10237-0788-33 Church 1 tube — — FDA listed —
Orajel 4X Medicated PM For Toothache and Gum 200 mg/g; 1.3 mg/g; 1.5 mg/g; 2.6 mg/g 10237-0789-25 Church 1 tube — — FDA listed —
4X Medicated Severe Toothache and Gum Cream 20 g/100g; .26 g/100g; .15 g/100g; .13 g/100g 11822-0614-09 Rite 1 tube — — FDA listed —
Nighttime 4X Medicated Cream .13 g/100g; 20 g/100g; .15 g/100g; .26 g/100g 11822-6300-01 Rite 1 tube — — FDA listed —
4x Medicated Toothache and Gum Cream 20 g/100g; .13 g/100g; .15 g/100g; .25 g/100g 37808-0116-69 HEB 1 tube — — FDA listed —
DG 4x Medicated Tooth and Gum Cream .15 g/100g; .13 g/100g; .26 g/100g; 20 g/100g 55910-0660-09 Dollar 1 tube — — FDA listed —
PM Toothache Relief 20 g/100g; .26 g/100g; .15 g/100g; .13 g/100g 69842-0623-09 CVS 1 tube — — FDA listed —
4x Medicated Toothache and Gum Cream .13 g/100g; .15 g/100g; 20 g/100g; .26 g/100g 69842-0631-19 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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 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 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.

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

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

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

LabelerWalgreens
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio342 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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

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

⏱️ Dosage and Administration 75 words ▾

Directions cut open tip of tube on score mark * adults and children 2 years of age and older: 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 dentist or doctor * 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 196 words ▾

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 develop: * 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 told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergice reaction occurs Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 32 words ▾

Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . Oral pain reliever Menthol 0.26% . . . Oral pain reliever Zinc chloride 0.15% . . . Oral astringent

🧪 Inactive Ingredients 11 words ▾

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

🎯 Purpose 20 words ▾

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

📄 Stop Use and Ask a Doctor If 33 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 67 words ▾

do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

📄 Package Label / Principal Display Panel 2 words ▾

5820627 2821627R2

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 — 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 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 Walgreens. 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 (00363-0607-79). 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?
Walgreens 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.
← 00363-0606-03 · Walgreens 00363-0618-01 · Walgreens →
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.