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Topicale Xtra Benzocaine 200 mg/g Gel, 28.35 g — NDC 10733-0175-01 package photo

Topicale Xtra Benzocaine 200 mg/g Gel, 28.35 g

by Medical Products Laboratories, Inc. · 28.35 g in 1 BOTTLE, PLASTIC (10733-175-01)
NDC 10733-0175-01
🏷️ FDA NDC (as labeled) 10733-175-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

⚠️
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

FDA NDC (as labeled) 10733-175-01
Product NDC 10733-175
11-digit billing NDC 10733017501
RxCUI 238910, 864735
UNII U3RSY48JW5
Application # M022
SPL Set ID e3d924b5-0788-46d3-e053-2995a90a027b
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 2022-08-22
Route ORAL
Dosage form GEL
Substance BENZOCAINE
Why two NDCs? The FDA registers this code as 10733-175-01 — 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 → 10733-0175-01. 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

LabelerMedical Products Laboratories, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code10733
First marketedAug 2022
Product typeHuman Otc Drug
Portfolio11 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.

🩺 Clinical

🧪 What is this product?

Topicale Xtra Benzocaine 200 mg/g Gel is an over-the-counter oral gel that contains benzocaine, a local anesthetic. This product is marketed under FDA's OTC monograph rules for its category. Benzocaine is typically used to numb minor mouth and throat pain, such as discomfort from canker sores, minor cuts, or sore gums. The gel form allows the anesthetic to be applied directly to affected areas inside the mouth.

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.

💊 What it looks like

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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII K6MOM3T5YL
    A synthetic polymer made from acrylic acid, crosslinked for stability. Used as a thickener and gelling agent to give medicines like creams and gels their texture, and as a binder to hold tablet ingredients together.
  • 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 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.

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

The official label also statesBenzalkonium Chloride (as a preservative), Carbomers, FD&C Blue Dye # 1, FD&C Yellow Dye # 5, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
HurriCaine Topical Anesthetic 200 mg/g 00283-0220-34 Beutlich 4 syringes — — Discontinued —
HurriCaine Topical Anesthetic Gel 200 mg/g 00283-0293-53 Beutlich 60 cups — — Discontinued —
HurriCaine Topical Anesthetic 200 mg/g 00283-0520-34 Beutlich 4 syringes — — Discontinued —
HurriCaine Topical Anesthetic 200 mg/g 00283-0522-27 Beutlich 42.52 g — — FDA listed —
HurriCaine Topical Anesthetic 200 mg/g 00283-0622-34 Beutlich 4 syringes — — FDA listed —
HurriCaine Topical Anesthetic 200 mg/g 00283-0871-31 Beutlich 1 bottle — — FDA listed —
HurriCaine Topical Anesthetic Gel 200 mg/g 00283-0886-31 Beutlich 28.4 g — — FDA listed —
HurriCaine Topical Anesthetic 200 mg/g 00283-0920-34 Beutlich 4 syringes — — Discontinued —
HurriCaine Topical Anesthetic 200 mg/g 00283-0998-31 Beutlich 28.4 g — — FDA listed —
HurriCaine Topical Anesthetic 200 mg/g 00283-1016-31 Beutlich 1 bottle — — FDA listed —
HurriCaine Topical Anesthetic 200 mg/g 00283-1820-34 Beutlich 4 syringes — — Discontinued —
Walgreens Pain Relief 200 mg/g 00363-5061-33 Walgreens 1 tube — — FDA listed —
Benzo-Jel 200 mg/g 00404-0032-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0033-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0034-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0035-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0036-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0037-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0038-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0039-30 Henry 30 g — — FDA listed —
UltraCare Anesthetic Gel 200 mg/g 10129-0071-01 The 30 g — — FDA listed —
7 Select Oral Pain Maximum Strength Relief 200 mg/g 10202-0853-14 7-ELEVEN, 1 tube — — FDA listed —
Topicale Xtra 200 mg/g 10733-0174-01 Medical 28.35 g — — FDA listed —
Topicale Xtra 200 mg/gthis 10733-0175-01 Medical 28.35 g — — FDA listed —
Topicale Xtra 200 mg/g 10733-0176-01 Medical 28.35 g — — FDA listed —
Sheffield Pain Relief 200 mg/g 11527-0062-55 Sheffield 1 tube — — Discontinued —
Rite Aid Maximum Strength 20 g/100g 11822-0316-03 Rite 1 tube — — FDA listed —
Kolorz Topical Anesthetic Triple Mint 200 mg/g 25047-0751-01 DMG 29.6 g — — FDA listed —
Kolorz Topical Anesthetic Cherry Burst 200 mg/g 25047-0752-01 DMG 29.6 g — — FDA listed —
Kolorz Topical Anesthetic Cotton Candy 200 mg/g 25047-0753-01 DMG 29.6 g — — FDA listed —
Kolorz Topical Anesthetic Blue Rasberry 200 mg/g 25047-0754-01 DMG 29.6 g — — FDA listed —
Kolorz Topical Anesthetic Pina Colada 200 mg/g 25047-0755-01 DMG 29.6 g — — FDA listed —
Anadent Kanka Gel 200 mg/g 27854-0177-01 BELMORA 1 tube — — FDA listed —
TopCare Oral Pain Relief Maximum Strength 20 g/100g 36800-0512-29 Topco 1 tube — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1101-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1102-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1103-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1104-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1105-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1106-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1107-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1108-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1109-03 IQ 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0028-30 National 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0029-30 National 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0031-30 National 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0032-30 National 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0033-30 National 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0034-30 National 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0001-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0002-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0003-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0004-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0005-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0006-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0007-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0008-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0009-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0010-03 Pearson 30 g — — FDA listed —
Oral Pain Relief 20 g/100g 43473-0100-04 Nantong 1 tube — — FDA listed —
MyMedic Oral Pain Relief Gel 20 g/100g 43473-0306-01 Nantong 75 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0310-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0311-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0312-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0313-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0314-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0315-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0316-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0317-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0318-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0319-30 Burkhart 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1001-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1002-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1003-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1004-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1005-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1007-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1009-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1010-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1011-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1012-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1013-03 Patterson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1014-03 Patterson 30 g — — FDA listed —
Goodsense Oral Pain Relief 20 g/100g 50804-0191-10 Geiss, 1 tube — — FDA listed —
Oral Pain Relief 20 g/100g 52000-0443-04 Universal 1 tube — — FDA listed —
Family Wellness Oral Pain Relief .2 g/g 55319-0108-14 FAMILY 1 tube — — FDA listed —
Family Wellness Pain Relief 200 mg/g 55319-0157-33 FAMILY 1 tube — — FDA listed —
Alpha-Caine Topical Anesthetic 200 mg/g 55346-2901-01 Dental 30 g — — FDA listed —
Alpha-Caine Topical Anesthetic 200 mg/g 55346-2902-01 Dental 30 g — — FDA listed —
Alpha-Caine Topical Anesthetic 200 mg/g 55346-2903-01 Dental 30 g — — FDA listed —
Alpha-Caine Topical Anesthetic 200 mg/g 55346-2904-01 Dental 30 g — — FDA listed —
Oral Pain Relief 200 mg/g 57896-0139-05 GERI-CARE 1 tube — — FDA listed —
CVS Pharmacy Maximum Strength 20 g/100g 59779-0582-09 CVS 1 tube — — Discontinued —
LolliCaine Bubble Gum 200 mg/g 60640-8800-01 Centrix, 120 doses — — FDA listed —
LolliCaine Cherry 200 mg/g 60640-9000-01 Centrix, 120 doses — — FDA listed —
LolliCaine Mint 200 mg/g 60640-9200-01 Centrix, 120 doses — — FDA listed —
LolliCaine Pina Colada 200 mg/g 60640-9400-01 Centrix, 120 doses — — FDA listed —
Quality Choice Maximum Strength Oral Pain Relieving 20 g/100g 63868-0953-11 Chain 1 tube — — FDA listed —
Iodent Oral Analgesic 200 mg/g 65923-0094-11 United 1 tube — — FDA listed —
BENZOCAINE Cherry 220 mg/g 66467-4002-02 Darby 30 g — — FDA listed —
BENZOCAINE Strawberry 220 mg/g 66467-4006-02 Darby 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0340-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0341-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0343-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0350-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0351-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0352-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0353-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0354-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0355-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0356-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0357-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0358-30 Benco 30 g — — FDA listed —
WinCo Foods Maximum Strength Oral Analgesic 200 mg/g 67091-0198-11 WinCo 1 tube — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0218-01 Safco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0219-01 Safco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0220-01 Safco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0221-01 Safco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0222-01 Safco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0223-01 Safco 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0350-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0351-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0352-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0353-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0354-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0355-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0357-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0358-30 Mycone 30 g — — FDA listed —
Gelato Topical Anesthetic 200 mg/g 68400-0359-30 Mycone 30 g — — FDA listed —
Comfortcaine Topical Anesthetic 200 mg/g 68400-0459-30 Mycone 30 g — — FDA listed —
Comfortcaine Topical Anesthetic 200 mg/g 68400-0460-30 Mycone 30 g — — FDA listed —
Comfortcaine Topical Anesthetic 200 mg/g 68400-0461-30 Mycone 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0475-30 Mycone 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0477-30 Mycone 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0478-30 Mycone 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0479-30 Mycone 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0508-30 Mycone 30 g — — FDA listed —
McKesson Orasol Gel 200 mg/g 68599-8247-04 McKesson 75 packets — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0001-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0002-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0003-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0004-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0005-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0006-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0007-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0008-30 PureLife 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0001-30 Group 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0002-30 Group 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0003-30 Group 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0004-30 Group 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0005-30 Group 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0006-30 Group 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0001-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0002-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0003-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0004-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0005-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0006-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0007-30 Top 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0001-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0002-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0003-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0004-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0005-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0006-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0007-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0008-30 ICP 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0009-30 ICP 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0001-30 Tiger 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0002-30 Tiger 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0003-30 Tiger 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0004-30 Tiger 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0005-30 Tiger 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0006-30 Tiger 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0001-30 iSmile 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0002-30 iSmile 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0003-30 iSmile 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0004-30 iSmile 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0005-30 iSmile 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0006-30 iSmile 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0001-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0002-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0003-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0004-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0005-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0006-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0007-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0008-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0009-30 Tri 30 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0351-30 Maxill 28 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0352-30 Maxill 28 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0353-30 Maxill 28 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0355-30 Maxill 28 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0358-30 Maxill 28 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0020-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0021-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0022-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0023-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0024-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0025-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0026-30 Dental 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0027-30 Dental 30 g — — FDA listed —
Defend 200 mg/g 70721-0001-30 Mydent 30 g — — FDA listed —
Defend 200 mg/g 70721-0002-30 Mydent 30 g — — FDA listed —
Defend 200 mg/g 70721-0003-30 Mydent 30 g — — FDA listed —
Defend 200 mg/g 70721-0004-30 Mydent 30 g — — FDA listed —
Defend 200 mg/g 70721-0005-30 Mydent 30 g — — FDA listed —
Defend 200 mg/g 70721-0006-30 Mydent 30 g — — FDA listed —
Defend 200 mg/g 70721-0007-30 Mydent 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0100-30 The 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0101-30 The 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0102-30 The 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0103-30 The 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0104-30 The 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0105-30 The 30 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0100-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0101-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0102-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0103-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0104-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0105-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0106-30 Zag 28 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0107-30 Zag 28 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0100-30 American 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0101-30 American 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0102-30 American 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0103-30 American 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0104-30 American 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0105-30 American 30 g — — FDA listed —
Oral pain relief .2 g/g 73492-0717-50 ALAINA 1 tube — — FDA listed —
Prime-Gel .2 g/g 77794-0018-00 Prime 24 bottles — — Discontinued —
Equate Orasol 200 mg/g 79903-0966-09 WAL-MART 1 tube — — FDA listed —
Anbesol Maximum Strength 200 mg/g 80070-0220-33 Foundation 1 tube — — FDA listed —
Oral Pain Relief Gel 200 mg/g 81417-0001-01 Sled 75 g — — FDA listed —
Quality Choice 200 mg/g 83324-0299-42 Chain 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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.

🔬 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 Topicale Xtra (this brand).

Top reported reactions

Methaemoglobinaemia124
Drug Hypersensitivity61
Asthenia48
Nausea46
Dyspnoea38
Arthralgia36
Anxiety35

Age at onset

Neonate7
Infant3
Child2
Adolescent3
Adult79
Elderly34

Reporter sex

756 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 66 4
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
10733-0175-01 You're viewing this 28.35 g in 1 BOTTLE, PLASTIC (10733-175-01) 2022-08-22 Active

🧭 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 FDA registers it as 10733-175-01, 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: 10733-0175-01, written without dashes as 10733017501. 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 10733-0175-01, the first segment (10733) is the labeler code FDA assigned to Medical Products Laboratories, Inc.; the middle segment (0175) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Medical Products Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medical Products Laboratories, 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 36 words ▾

For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

⏱️ Dosage and Administration 71 words ▾

Do not use more than directed. Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children 2-12 years of age - Should be supervised in the use of the product. Children under 2 years of age - Do not use.

⚠️ Warnings 202 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 develops pale, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light headedness, fatigue or lack of energy.

Contraindications: Do not use in large quantities or over large areas of body Do not use for Teething Do not use in children under 2 years of age Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Stop use and ask a doctor 1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting 2.

If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens

🧪 Active Ingredient 2 words ▾

Benzocaine 20%

🧪 Inactive Ingredients 23 words ▾

Benzalkonium Chloride (as a preservative), Carbomers, FD&C Blue Dye # 1, FD&C Yellow Dye # 5, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium

🎯 Purpose 2 words ▾

Oral Anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10733-0174-01 · Medical 10733-0176-01 · Medical →
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.