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Candee Caine Topical Anesthetic Benzocaine 200 mg/g Gel, 30 g — NDC 69301-0057-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Candee Caine Topical Anesthetic Benzocaine 200 mg/g Gel, 30 g — NDC 69301-057-30 (Billing 69301-0057-30)

by Top Quality Manufacturing, Inc. · 30 g in 1 JAR

This is a package of 30 g of Candee Caine Topical Anesthetic Benzocaine 200 mg/g Gel from Top Quality Manufacturing, Inc., marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 69301-0057-30
🏷️ FDA NDC (as labeled) 69301-057-30 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Benzocaine (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69301-057-30
Product NDC 69301-057
11-digit billing NDC 69301005730
RxCUI 238910, 1992043
UNII U3RSY48JW5
Application # M022
SPL Set ID 58690bb5-9604-26a4-e063-6394a90afdbe
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 2026-08-03
Route DENTAL
Dosage form GEL
Substance BENZOCAINE
Quick answers
  • RxCUI (RxNorm): 238910
Why two NDCs? The FDA registers this code as 69301-057-30 — 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 → 69301-0057-30. 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.

Clinical

🧪 What is this product?

Candee Caine is an over-the-counter topical anesthetic gel applied to the gums and oral tissues. It contains benzocaine, a local anesthetic commonly used to numb minor mouth and gum pain. This product is marketed under FDA's OTC monograph rules for oral anesthetics. Benzocaine works by temporarily blocking nerve signals in the area where it is applied.

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzocaine — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzocaine (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
69301-0057-30 You're viewing this Main listing 30 g in 1 JAR 2026-08-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 —
Quala Topical Anesthetic Gel 200 mg/g 68400-0508-30 Mycone 30 g — — FDA listed —
Kolorz Topical Anesthetic Blue Rasberry 200 mg/g 25047-0754-01 DMG 29.6 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0009-03 Pearson 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 50227-1011-03 Patterson 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0353-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0356-30 Benco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0222-01 Safco 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0477-30 Mycone 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0006-30 PureLife 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0006-30 Group 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0005-30 iSmile 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0004-30 Tri 30 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0027-30 Dental 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 —
Advance Topical Anesthetic Gel 200 mg/g 71347-0102-30 The 30 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0100-30 Zag 28 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0100-30 American 30 g — — FDA listed —
Kolorz Topical Anesthetic Cherry Burst 200 mg/g 25047-0752-01 DMG 29.6 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 —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1002-03 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 —
BencoCaine Topical Anesthetic 200 mg/g 66975-0341-30 Benco 30 g — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0218-01 Safco 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0478-30 Mycone 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0005-30 PureLife 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0002-30 Group 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0002-30 Tri 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0101-30 The 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0104-30 American 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0002-03 Pearson 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0318-30 Burkhart 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 —
PureLife Topical Anesthetic 200 mg/g 68987-0004-30 PureLife 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0007-30 PureLife 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0005-30 Group 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0001-30 Top 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 69483-0005-30 ICP 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0005-30 Tiger 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0007-30 Tri 30 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 —
Defend 200 mg/g 70721-0007-30 Mydent 30 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 71363-0107-30 Zag 28 g — — FDA listed —
Kolorz Topical Anesthetic Cotton Candy 200 mg/g 25047-0753-01 DMG 29.6 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0031-30 National 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0008-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0010-03 Pearson 30 g — — FDA listed —
LolliCaine Cherry 200 mg/g 60640-9000-01 Centrix, 120 doses — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0352-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0355-30 Benco 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 68400-0479-30 Mycone 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 69483-0007-30 ICP 30 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0355-30 Maxill 28 g — — FDA listed —
Defend 200 mg/g 70721-0005-30 Mydent 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0100-30 The 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0105-30 American 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 43128-0034-30 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 43305-0005-03 Pearson 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0006-03 Pearson 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0311-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0317-30 Burkhart 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1003-03 Patterson 30 g — — FDA listed —
LolliCaine Mint 200 mg/g 60640-9200-01 Centrix, 120 doses — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0343-30 Benco 30 g — — FDA listed —
Comfortcaine Topical Anesthetic 200 mg/g 68400-0460-30 Mycone 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0001-30 PureLife 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0005-30 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 69483-0008-30 ICP 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0003-30 iSmile 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0005-30 Tri 30 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0105-30 Zag 28 g — — FDA listed —
Kolorz Topical Anesthetic Triple Mint 200 mg/g 25047-0751-01 DMG 29.6 g — — FDA listed —
Kolorz Topical Anesthetic Pina Colada 200 mg/g 25047-0755-01 DMG 29.6 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1102-03 IQ 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 43128-0032-30 National 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0312-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0315-30 Burkhart 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 —
LolliCaine Pina Colada 200 mg/g 60640-9400-01 Centrix, 120 doses — — FDA listed —
Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g 67239-0219-01 Safco 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 68400-0475-30 Mycone 30 g — — FDA listed —
GPS Topical Anesthetic 200 mg/g 69004-0001-30 Group 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0001-30 Tiger 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0001-30 iSmile 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 69510-0353-30 Maxill 28 g — — FDA listed —
Health-Tec Topical Anesthetic 200 mg/g 69634-0023-30 Dental 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0034-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0038-30 Henry 30 g — — FDA listed —
Defend 200 mg/g 70721-0006-30 Mydent 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0313-30 Burkhart 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0316-30 Burkhart 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0350-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0354-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0358-30 Benco 30 g — — FDA listed —
Comfortcaine Topical Anesthetic 200 mg/g 68400-0459-30 Mycone 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0003-30 PureLife 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 69301-0006-30 Top 30 g — — FDA listed —
iSmile Topical Anesthetic 200 mg/g 69498-0002-30 iSmile 30 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0352-30 Maxill 28 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 69634-0026-30 Dental 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0036-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0039-30 Henry 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 —
Candee Caine Topical Anesthetic 200 mg/g 71922-0102-30 American 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0028-30 National 30 g — — FDA listed —
Pearson Topical Anesthetic 200 mg/g 43305-0007-03 Pearson 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1001-03 Patterson 30 g — — FDA listed —
LolliCaine Bubble Gum 200 mg/g 60640-8800-01 Centrix, 120 doses — — 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 67239-0223-01 Safco 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0002-30 PureLife 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 —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0002-30 Top 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0007-30 Top 30 g — — FDA listed —
Dental City Topical Anesthetic 200 mg/g 69483-0004-30 ICP 30 g — — FDA listed —
Tiger Supply Inc Topical Anesthetic 200 mg/g 69484-0006-30 Tiger 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0001-30 Tri 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 71363-0102-30 Zag 28 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1104-03 IQ 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 —
Burkhart Topical Anesthetic 200 mg/g 43498-0310-30 Burkhart 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0340-30 Benco 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0351-30 Benco 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 69483-0009-30 ICP 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 —
iSmile Topical Anesthetic 200 mg/g 69498-0004-30 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 69509-0008-30 Tri 30 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0351-30 Maxill 28 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 69634-0025-30 Dental 30 g — — 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 00404-0035-30 Henry 30 g — — FDA listed —
Benzo-Jel 200 mg/g 00404-0037-30 Henry 30 g — — FDA listed —
Advance Topical Anesthetic Gel 200 mg/g 71347-0103-30 The 30 g — — FDA listed —
Astra-dent Topical Anesthetic Gel 200 mg/g 71363-0101-30 Zag 28 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0101-30 American 30 g — — FDA listed —
Anadent Kanka Gel 200 mg/g 27854-0177-01 BELMORA 1 tube — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1101-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1103-03 IQ 30 g — — FDA listed —
NRG Topical Anesthetic 200 mg/g 42756-1105-03 IQ 30 g — — FDA listed —
Quala Topical Anesthetic Gel 200 mg/g 43128-0033-30 National 30 g — — FDA listed —
Burkhart Topical Anesthetic 200 mg/g 43498-0314-30 Burkhart 30 g — — FDA listed —
Patterson Dental Topical Anesthetic 200 mg/g 50227-1014-03 Patterson 30 g — — FDA listed —
BencoCaine Topical Anesthetic 200 mg/g 66975-0357-30 Benco 30 g — — FDA listed —
PureLife Topical Anesthetic 200 mg/g 68987-0008-30 PureLife 30 g — — FDA listed —
Top Quality Mfg. Topical Anesthetic 200 mg/g 69301-0004-30 Top 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0003-30 Tri 30 g — — FDA listed —
Primo Topical Anesthetic 200 mg/g 69509-0006-30 Tri 30 g — — FDA listed —
Ipana 20% Benzocaine Topical 200 mg/g 69510-0358-30 Maxill 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 71363-0106-30 Zag 28 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/g 71922-0103-30 American 30 g — — FDA listed —
Candee Caine Topical Anesthetic 200 mg/gthis 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
FlavorCherry
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.

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.

Manufacturer & labeler

LabelerTop Quality Manufacturing, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code69301
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio23 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

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

⏱️ Dosage and Administration 22 words ▾

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

⚠️ Warnings 200 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 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 7 words ▾

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

🧪 Active Ingredient 5 words ▾

Benzocaine 200mg (in each g)

🧪 Inactive Ingredients 30 words ▾

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 2 words ▾

Oral Anesthetic

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 Candee Caine Topical Anesthetic (this brand).

Top reported reactions

Methaemoglobinaemia124
Drug Hypersensitivity62
Asthenia48
Nausea46
Dyspnoea38
Arthralgia36
Anxiety35

Age at onset

Neonate7
Infant3
Child2
Adolescent3
Adult79
Elderly34

Reporter sex

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

Serious outcomes

Hospitalization309
Life-threatening112
Death68
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.

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) — 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 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 Top Quality Manufacturing, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Top Quality Manufacturing, 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.
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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.