NDC 10157-9302-04 — Blistex Foille Medicated First Aid Benzocaine

🆔 Identity & classification

FDA NDC (as labeled) 10157-9302-4

Product NDC 10157-9302

11-digit billing NDC 10157930204

RxCUI 199005, 213034

UNII U3RSY48JW5, 0F32U78V2Q

UPC 0041388003023

Application # M017

SPL Set ID e2eca808-e97b-43e0-aa51-7025cc61c7a8

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 2013-03-05

Route TOPICAL

Dosage form OINTMENT

Substance BENZOCAINE; CHLOROXYLENOL

GPI-14 90859902284230

GPI class Foille

GCN Seq No 016644

GCN 67820

HICL code 011191

Ingredient (HICL) Benzocaine/Chloroxylenol

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q5H

Therapeutic class — specific (HIC3) Topical Local Anesthetics

AHFS code 84:08.00.00

AHFS class Antipruritics And Local Anesthetics

FDB label name FOILLE OINTMENT

FDB brand name Foille

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 10157-9302-4 — a 5-4-1 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 package segment → 10157-9302-04. 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

LabelerBlistex Inc.

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code10157

First marketedMar 2013

Product typeHuman Otc Drug

Portfolio17 products on file

🔎 All NDCs from Blistex Inc.

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

Label name FOILLE OINTMENT Ingredient Benzocaine/Chloroxylenol

🧪 What is this product?

This is a topical first aid ointment that combines two active ingredients commonly used to address minor cuts, scrapes, and sores. Benzocaine is a local anesthetic that typically works to numb pain on the skin surface, while chloroxylenol functions as an antiseptic to help reduce bacteria. The product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for this category of first aid ointments.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 14 g

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Blistex Foille Medicated First Aid 5 g/100g; .1 g/100gthis 10157-9302-04	Blistex	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

🏛️

2013

On the market since

Mar 2013

📍

2026

Currently FDA-listed

13 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
10157-9302-03	1 TUBE in 1 CARTON (10157-9302-3) / 14 g in 1 TUBE	2016-09-23	Active
10157-9302-04 You're viewing this	1 TUBE in 1 CARTON (10157-9302-4) / 28 g in 1 TUBE	2013-03-05	Active

Pack size FAQ

What quantity is in NDC 10157-9302-04?

NDC 10157-9302-04 is listed by the FDA — 1 tube in 1 carton / 28 g in 1 tube.

What NDC number is used to bill for this package of Blistex Foille Medicated First Aid Benzocaine and Chloroxylenol 5 g/100g; .1 g/100g Ointment?

Bill NDC 10157-9302-04 — the 11-digit billing format is 10157930204. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 10157-9302-4, 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: 10157-9302-04, written without dashes as 10157930204. 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 10157-9302-04, the first segment (10157) is the labeler code FDA assigned to Blistex Inc.; the middle segment (9302) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Blistex Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (10157-9302-03). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Blistex 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 33 words ▾

Uses For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. First aid to help prevent infection in minor cuts, scrapes and burns.

⏱️ Dosage and Administration 35 words ▾

Directions Clean the affected area. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

⚠️ Warnings 85 words ▾

Warnings For external use only When using this product Avoid contact with the eyes Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information Avoid contact with clothing. Foille may stain certain fabrics.

🧪 Active Ingredient 14 words ▾

Active ingredients Purpose Benzocaine 5.0 % (w/w) External analgesic Chloroxylenol 0.1 % (w/w) Antiseptic

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, citric acid, eugenol, hydrogenated coconut oil, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil

🎯 Purpose 14 words ▾

Active ingredients Purpose Benzocaine 5.0 % (w/w) External analgesic Chloroxylenol 0.1 % (w/w) Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Benzocaine And Chloroxylenol NDCsSame ingredient 🏭 All Blistex labeler NDCsLabeler code 10157 📚 All Standardized Chemical Allergen NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Local Anesthetics.

Pramoxine Hcl 00316-0230-75 Dyclonine Hcl 00362-3971-05 Lidocaine Hcl 00536-1139-20 Dibucaine 00536-1211-95 Tetracaine/Benzocaine/Butamben 10223-0201-03 Benzocaine 16864-0640-01 Benzocaine/Benzethon Cl 16864-0670-01 Benzocaine/Menthol 16864-0680-01 Lidocaine/Aloe Vera 46122-0555-28 Lidocaine/Menthol 46122-0574-21 Lidocaine Hcl/Benzalkonium Chl 46122-0656-25 Benzocaine/Resorcinol 63868-0949-01 Dyclonine Hcl/Benzethonium Cl 70000-0599-01 Lidocaine 71205-0288-50

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.