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Walgreens Mouth Sore Relief Benzocaine 200 mg/mL Liquid, 1 bottle — NDC 00363-5334-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Walgreens Mouth Sore Relief Benzocaine 200 mg/mL Liquid, 1 bottle — NDC 0363-5334-00 (Billing 00363-5334-00)

by Walgreens · 1 BOTTLE in 1 BLISTER PACK / 14.7 mL in 1 BOTTLE

This is a package of 1 bottle of Walgreens Mouth Sore Relief Benzocaine 200 mg/mL Liquid from Walgreens, marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.

NDC 00363-5334-00
🏷️ FDA NDC (as labeled) 0363-5334-00 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 0363-5334-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0363 labeler · 5334 product · 00 package
Package marketed since
Dec 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0311917053288
FDA record last changed
Jul 24, 2026
⚠️
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) 0363-5334-00
Product NDC 0363-5334
11-digit billing NDC 00363533400
RxCUI 308657
UNII U3RSY48JW5
UPC 0311917053288
Application # M022
SPL Set ID 253d7ea2-e48e-c7d7-e063-6394a90ae001
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 2024-10-31
Route ORAL
Dosage form LIQUID
Substance BENZOCAINE
Quick answers
  • RxCUI (RxNorm): 308657
Why two NDCs? The FDA registers this code as 0363-5334-00 — 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 → 00363-5334-00. 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?

Walgreens Mouth Sore Relief is an over-the-counter liquid product applied directly to the inside of the mouth. It contains benzocaine, a local anesthetic that is typically used to numb pain and discomfort from minor mouth sores, canker sores, and similar oral irritations. This product is marketed under FDA's monograph rules for OTC oral anesthetics rather than as an individually approved drug application.

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 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.
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
00363-5334-00 You're viewing this Main listing 1 BOTTLE in 1 BLISTER PACK / 14.7 mL in 1 BOTTLE 2024-12-01 — Active

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/mLthis 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/g 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 —
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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color brown
FlavorMint
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 8RZ43KFB5K
    A synthetic polymer made from multiple acrylic compounds blended together. It's used as a film-coating agent to create a protective shell around tablets or capsules, controlling how and when the medicine dissolves in your body.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII L7J6A1NE81
    Benzoin is a natural resin from tree bark used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth in liquid formulations and topical products.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII D9OM4SK49P
    Cetylpyridinium chloride is a chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial growth and extends the shelf life of liquid formulations.
  • UNII SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII JD797EF70J
    A synthetic fatty alcohol made from oils, oleth-10 works as an emulsifier and solubilizer in medicines. It helps mix water and oil-based ingredients together and keeps them blended throughout the product's shelf life.
  • UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 7EK4SFN1TX
    A natural oil derived from castor bean seeds, used as a lubricant and emollient to help the medicine slide smoothly during manufacturing and improve how it feels when taken.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 28F9E0DJY6
    Tannic acid is a plant-derived compound that acts as an astringent and antioxidant in medications. It's used to help bind ingredients together, preserve the product, and reduce moisture absorption in solid dosage forms.

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

The official label also statesbenzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38B, sucralose, tannic 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.

Manufacturer & labeler

LabelerWalgreens
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio342 products on file

More NDCs from Walgreens labeler code 00363

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

for the temporary relief of pain due to the canker sores, minor irritation of the mouth and gums caused by dentures or othodontic appliances, or minor injury of the mouth or gums

⏱️ Dosage and Administration 75 words ▾

adults and children 2 years of age and over: to assure formation of long0lasting film coating, dry affected area and apply medication undiluted with a cotton swab or fingertip; allow a few seconds for coating to for; 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 103 words ▾

Methemoglobinemia warning: use of this product may cuase methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oygen 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: plae, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness of 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 2 words ▾

Benzocaine 20%

🧪 Inactive Ingredients 30 words ▾

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil , SD alcohol 38B, sucralose, tannic acid

🎯 Purpose 2 words ▾

Oral anesthetic/analgesic

📄 Keep Out of Reach of Children 26 words ▾

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

📄 Package Label / Principal Display Panel 5 words ▾

2824635R1 WLG Mouth Sore Relief

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 ✓ 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 Walgreens. Listing status can change — the directory data on this page refreshes weekly.
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.
← 00363-5309-06 · WALGREENS 00363-5337-19 · 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.