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3x Medicated Mouth Sore Gel Benzocaine .1 g/100g; 20 g/100g; .15 g/100g Gel, 1 tube — NDC 37808-691-19 (Billing 37808-0691-19)

by HEB · 1 TUBE in 1 CARTON / 9.4 g in 1 TUBE

This is a package of 1 tube of 3x Medicated Mouth Sore Gel Benzocaine .1 g/100g; 20 g/100g; .15 g/100g Gel from HEB, marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 37808-0691-19
🏷️ FDA NDC (as labeled) 37808-691-19 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 37808-691-19 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
37808 labeler · 691 product · 19 package
Package marketed since
Jun 2, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0041220331512
FDA record last changed
Aug 27, 2026
⚠️
Other active recalls for Benzocaine (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 37808-691-19
Product NDC 37808-691
11-digit billing NDC 37808069119
RxCUI 2266762
UNII L7T10EIP3A, U3RSY48JW5, 86Q357L16B
UPC 0041220331512
Application # M022
SPL Set ID a71c5259-cbd1-7566-e053-2995a90a2cb6
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 2020-06-02
Route ORAL
Dosage form GEL
Substance MENTHOL, UNSPECIFIED FORM; BENZOCAINE; ZINC CHLORIDE
Quick answers
  • RxCUI (RxNorm): 2266762
Why two NDCs? The FDA registers this code as 37808-691-19 — 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 → 37808-0691-19. 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?

This is an over-the-counter oral gel product marketed under FDA's OTC monograph rules for mouth sore relief. It contains benzocaine, a local anesthetic typically used to numb minor mouth pain and irritation, along with menthol, which is commonly included for its cooling sensation. Zinc chloride is also present in the formulation. The gel is applied directly to the affected area of the mouth to help soothe discomfort from minor sores and irritations.

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
37808-0691-19 You're viewing this Main listing 1 TUBE in 1 CARTON / 9.4 g in 1 TUBE 2020-06-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
3x Medicated Mouth Sore Gel .15 g/100g; .1 g/100g; 20 g/100g 00363-1605-19 Walgreens 1 tube — — FDA listed —
Orajel 3X Medicated For All Mouth Sores 200 mg/g; 1 mg/g; 1.5 mg/g 10237-0783-12 Church 1 tube — — FDA listed —
3X Medicated Mouth Sore Gel 20 g/100g; .1 g/100g; .15 g/100g 11822-6170-09 Rite 1 tube — — FDA listed —
3x Medicated Mouth Sore Gel .1 g/100g; 20 g/100g; .15 g/100gthis 37808-0691-19 HEB 1 tube — — FDA listed —
3x Medicated Mouth Sore Gel 20 g/100g; .1 g/100g; .15 g/100g 69842-0660-09 CVS 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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.

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

LabelerHEB
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code37808
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio89 products on file

More NDCs from HEB labeler code 37808

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 79 words ▾

Directions cut open tip of tube on score mark do not use if tip is cut prior to opening adults and children 2 years of age and older : apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children between 2 and 12 years of age : ask a doctor before use. Should be supervised in the use of this product children under 2 years of age : do not use

⏱️ Dosage and Administration 77 words ▾

cut open tip of tube on score mark do not use if tip is cut prior to opening adults and children 2 years of age and older : apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product children under 2 years of age : do not use

⚠️ Warnings 186 words ▾

Methemoglobinemia warning: use of this product may cause methoglobinemia, 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, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy Allergy alert Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritaiton, pain or redness persists or worsens Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 34 words ▾

Active ingredients Purpose Benzocaine 20% . . . . . .Oral pain reliever Menthol 0.1% . . . . . . . . Oral pain reliever Zinc chloride 0.15% . . . .Oral astringent

🧪 Inactive Ingredients 19 words ▾

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

🎯 Purpose 23 words ▾

for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

📄 Stop Use and Ask a Doctor If 28 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 27 words ▾

Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age

📄 Questions or Comments 5 words ▾

Questions and Comments? Call 1-877-7777-2743

📄 Package Label / Principal Display Panel 1 words ▾

HEB_3xmedicated_mouthsoregel_2821619R2

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 3x Medicated Mouth Sore Gel (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
Male · 35%
Female · 65%
Unknown · 1%

Serious outcomes

Life-threatening112
Disabling50
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 62 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 — 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 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 HEB. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HEB 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.
← 37808-0683-06 · H 37808-0692-13 · H →
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.