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iSmile Topical Anesthetic Benzocaine 200 mg/g Gel, 30 g

by iSmile Dental Products, Inc. · 30 g in 1 JAR (69498-003-30)
NDC 69498-0003-30
🏷️ FDA NDC (as labeled) 69498-003-30 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) 69498-003-30
Product NDC 69498-003
11-digit billing NDC 69498000330
RxCUI 238910
UNII U3RSY48JW5
Application # M022
SPL Set ID 1d6a1182-ab63-460a-ab91-8d4c2ae5d01e
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 2014-06-01
Route DENTAL
Dosage form GEL
Substance BENZOCAINE
Why two NDCs? The FDA registers this code as 69498-003-30 — 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 → 69498-0003-30. 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

LabeleriSmile Dental Products, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code69498
First marketedJun 2014
Product typeHuman Otc Drug
Portfolio6 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?

iSmile Topical Anesthetic Benzocaine 200 mg/g Gel is an over-the-counter dental gel containing benzocaine, a local anesthetic. This product is applied directly to the gums and mouth tissues and is typically used to provide temporary numbing relief from minor dental pain and discomfort. Benzocaine numbs the area by blocking nerve signals in the tissues where it is applied. This product is marketed under the FDA's over-the-counter monograph rules for oral anesthetics.

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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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/g 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/gthis 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 —
Candee Caine Topical Anesthetic 200 mg/g 69301-0057-30 Top 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 69301-0059-30 Top 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 69301-0060-30 Top 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 69301-0061-30 Top 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 69301-0056-30 Top 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 69301-0058-30 Top 30 g — — 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
Jun 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.

🔬 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 iSmile Topical Anesthetic (this brand).

Top reported reactions

Methaemoglobinaemia124
Drug Hypersensitivity61
Asthenia48
Nausea46
Dyspnoea38
Arthralgia36
Anxiety35

Reporter sex

756 reports
Male · 35%
Female · 65%
Unknown · 1%

Serious outcomes

Disabling50
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 66 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69498-0003-30 You're viewing this 30 g in 1 JAR (69498-003-30) 2018-06-01 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 69498-003-30, 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: 69498-0003-30, written without dashes as 69498000330. 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 69498-0003-30, the first segment (69498) is the labeler code FDA assigned to iSmile Dental Products, Inc.; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 iSmile Dental Products, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
iSmile Dental Products, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Use For oral mucosa use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

⏱️ Dosage and Administration 23 words ▾

Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use

⚠️ Warnings 201 words ▾

Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask a physician before use.

📦 Storage and Handling 9 words ▾

Other Information Store at 59°-86°F (15°-30°C). Protect from freezing.

🧪 Active Ingredient 7 words ▾

Active Ingredient Benzocaine 200mg (in each g)

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

🎯 Purpose 3 words ▾

Purpose Oral Anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69498-0002-30 · iSmile 69498-0004-30 · iSmile →
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.