Home › NDC Lookup › Ingredients › Benzocaine › 36800-0443-48
Topcare Maximum Strength Benzocaine 20 g/100g Liquid, 1 bottle — NDC 36800-0443-48 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Topcare Maximum Strength Benzocaine 20 g/100g Liquid, 1 bottle — NDC 36800-443-48 (Billing 36800-0443-48)

by Topco Associates LLC · 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK / 14.17 g in 1 BOTTLE, WITH APPLICATOR

This is a package of 1 bottle of Topcare Maximum Strength Benzocaine 20 g/100g Liquid from Topco Associates LLC, marketed since Oct 2014 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 36800-0443-48
🏷️ FDA NDC (as labeled) 36800-443-48 billing pads the product segment with a zero
This package
Contains1 bottle Pack sizes2 compare ↓
Main listing for product 36800-443 · Also comes in: 14.17 g 36800-443-58
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 36800-443-48 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
36800 labeler · 443 product · 48 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3680044348 9
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) 36800-443-48
Product NDC 36800-443
11-digit billing NDC 36800044348
RxCUI 308657
UNII U3RSY48JW5
Application # M022
SPL Set ID 6586fcda-b232-46b4-8461-c0042a4127c6
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 2014-10-01
Route ORAL
Dosage form LIQUID
Substance BENZOCAINE
Quick answers
  • RxCUI (RxNorm): 308657
Why two NDCs? The FDA registers this code as 36800-443-48 — 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 → 36800-0443-48. 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?

Topcare Maximum Strength Benzocaine is a liquid oral product containing 20 percent benzocaine. Benzocaine is a local anesthetic typically used to numb pain and discomfort in the mouth and throat. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and quality standards for this type of topical anesthetic rather than being individually reviewed by the agency.

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.
Try another pack size: 14.17 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
36800-0443-48 You're viewing this Main listing 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK / 14.17 g in 1 BOTTLE, WITH APPLICATOR 2014-10-01 — Active
36800-0443-58 36800-443-58 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK / 14.17 g in 1 BOTTLE, WITH APPLICATOR 2014-10-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 bottle — 1 bottle, with applicator in 1 blister pack / 14.17 g in 1 bottle, with applicator.
How does this package differ from NDC 36800-0443-58?
Both are Topcare Maximum Strength Benzocaine 20 g/100g Liquid — the drug itself is identical. This page's package is the 1 bottle one, while NDC 36800-0443-58 is the 1 bottle package.
What NDC number is used to bill for this package of Topcare Maximum Strength Benzocaine 20 g/100g Liquid?
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
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/mL 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/100gthis 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

🏛️
2014
On the market since
Oct 2014
📍
2026
Currently FDA-listed
12 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 red
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 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 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 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 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 statesInactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, 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

LabelerTopco Associates LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedOct 2014
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 36800

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

Uses Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures

⏱️ Dosage and Administration 57 words ▾

Directions Adults and children 2 years of age and older: apply to affected area using applicator tip 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: consult a dentist or doctor

⚠️ Warnings 103 words ▾

Warnings 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 When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor Stop use and ask doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 16 words ▾

Other information do not use if package has been opened store at 20 - 25°C (68-77°F)

🧪 Active Ingredient 5 words ▾

Active ingredient Benzocaine 20.0% (w/w)

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

🎯 Purpose 3 words ▾

Purpose Oral anesthetic

📄 When Using This Product 28 words ▾

When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 2 words ▾

Card R4

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 Benzocaine — the ingredient across all brands.

Top reported reactions

Methaemoglobinaemia175
Dyspnoea103
Nausea84
Drug Hypersensitivity75
Asthenia74
Pain74
Vomiting65

Reporter sex

1,507 reports
Male · 37%
Female · 63%
Unknown · 1%

Serious outcomes

Life-threatening184
Death135
Disabling73
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 129 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 Topco Associates LLC. 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 bottle (36800-0443-58). 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?
Topco Associates LLC 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.
← 36800-0441-64 · Topco 36800-0448-09 · Topco →
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.