NDC 11523-4338-01 — Lotrimin Ultra Athletes Foot Butenafine

🆔 Identity & classification

FDA NDC (as labeled) 11523-4338-1

Product NDC 11523-4338

11-digit billing NDC 11523433801

NCPDP billing unit GM — per gram (weight)

RxCUI 1298448

UNII R8XA2029ZI

UPC 0000000000000

Application # NDA021307

SPL Set ID e258c4ac-53ef-4a99-b732-4985f890b938

Established class (EPC) Benzylamine Antifungal

Chemical class Benzylamines

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2002-02-22

Route TOPICAL

Dosage form CREAM

Substance BUTENAFINE HYDROCHLORIDE

GPI-14 90150026103720

GPI class Lotrimin Ultra

GCN Seq No 029333

GCN 37521

HICL code 012258

Ingredient (HICL) Butenafine Hcl

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 Q5F

Therapeutic class — specific (HIC3) Topical Antifungals

AHFS code 84:04.08.12

AHFS class Benzylamines (Skin And Mucous Membrane)

FDB label name LOTRIMIN ULTRA 1% CREAM

FDB brand name Lotrimin Ultra

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

Why two NDCs? The FDA registers this code as 11523-4338-1 — 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 → 11523-4338-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Benzylamine Antifungal class.

Pharmacologic class Benzylamine Antifungal

Drug family (ATC) Other antifungals for topical use

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

LabelerBayer Healthcare LLC.

Application holderBAYER HEALTHCARE LLC

FDA applicationNDA021307 (NDA)

Labeler code11523

First marketedFeb 2002

Product typeHuman Otc Drug

Portfolio240 products on file

🔎 All NDCs from Bayer Healthcare LLC.

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 LOTRIMIN ULTRA 1% CREAM Ingredient Butenafine Hcl

📗 Our plain-language guide HelloPharmacist

Butenafine cream treats three common fungal skin infections: athlete's foot (between the toes), jock itch, and ringworm. It also helps relieve the itching, burning, cracking, and s...
What infections does butenafine cream actually treat?
You might notice your symptoms improving before you finish the full course, but it's really important to keep applying the cream as directed. For athlete's foot between the toes, y...
How long do I need to use it before it starts working?

📖 Read our full Butenafine guide →

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.

💊 What it looks like

Color white

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
UNII 495CTZ441V
Ceteth-23 is a synthetic emulsifier made by combining cetyl alcohol with ethylene oxide. It helps mix oil and water in liquid formulations and improves how the medicine spreads on skin or is absorbed.
UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
UNII 581437HWX2
A synthetic oily liquid made from propylene glycol and fatty acids. It works as an emollient and solubilizer in medicines, helping dissolve active ingredients and improve how the product spreads or absorbs.
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesbenzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price 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: 15 g 30 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
Athletes Foot 10 mg/g 70677-1269-01	STRATEGIC	1 tube	$0.310	—	Availability likely	—
Athletes Foot 10 mg/g 00363-2100-02	Walgreen	1 tube	—	—	FDA listed	—
Jock Itch 10 mg/g 00363-2101-08	Walgreen	1 tube	—	—	FDA listed	—
Lotrimin Ultra 1 g/100g 11523-0082-01	Bayer	1 tube	—	—	FDA listed	—
Lotrimin Ultra Ringworm 1 g/100g 11523-0158-02	Bayer	1 tube	—	—	FDA listed	—
Lotrimin Ultra Athletes Foot 1 g/100gthis 11523-4338-01	Bayer	1 tube	—	—	FDA listed	—
Lotrimin Ultra Jock Itch 1 g/100g 11523-4339-01	Bayer	1 tube	—	—	FDA listed	—
Athletes Foot 10 mg/g 11673-0016-02	Target	1 tube	—	—	FDA listed	—
Jock Itch Cream 10 mg/g 11673-0436-01	TARGET	1 tube	—	—	FDA listed	—
Athletes Foot 10 mg/g 11822-2100-02	Rite	1 tube	—	—	FDA listed	—
Butenafine Hydrochloride 10 mg/g 21130-0965-01	Albertsons	1 tube	—	—	FDA listed	—
Butenafine Hydrochloride Athletes Foot 10 mg/g 30142-0210-02	Kroger	1 tube	—	—	FDA listed	—
Athletes Foot 10 mg/g 36800-0049-01	TOPCO	1 tube	—	—	FDA listed	—
Athletes Foot Ultra 10 mg/g 37808-0013-02	H	1 tube	—	—	FDA listed	—
Butenafine Hydrochloride Jock Itch 10 mg/g 49035-0178-08	Wal-Mart	1 tube	—	—	FDA listed	—
Athletes Foot Ultra 10 mg/g 49035-0225-08	Wal-Mart	1 tube	—	—	FDA listed	—
Athletes Foot 10 mg/g 51672-2100-01	Sun	1 tube	—	—	FDA listed	—
Jock Itch 10 mg/g 51672-2101-01	Sun	1 tube	—	—	FDA listed	—
Athletes Foot 10 mg/g 69842-0986-02	CVS	1 tube	—	—	FDA listed	—
Butenafine Hydrochloride 1% 10 mg/g 69842-0989-08	CVS	1 tube	—	—	FDA listed	—
Butenafine Hydrochloride 10 mg/g 73581-0210-02	YYBA	1 tube	—	—	FDA listed	—
Butenafine Hydrochloride 10 mg/g 79481-0086-01	MEIJER	1 tube	—	—	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️

2002

On the market since

Feb 2002

📍

2026

Currently FDA-listed

24 years listed

🔓

·

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Lotrimin Ultra Athletes Foot (this brand).

Top reported reactions

Pruritus29

Condition Aggravated28

Rash20

Drug Ineffective For Unapproved Indication19

Erythema19

Drug Effect Decreased18

Drug Effective For Unapproved Indication17

Age at onset

Infant3

Adolescent5

Adult86

Elderly71

Reporter sex

Male · 60%

Female · 39%

Unknown · 1%

Serious outcomes

Hospitalization24

Life-threatening4

Disabling1

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
11523-4338-01 You're viewing this	1 TUBE in 1 CARTON (11523-4338-1) / 12 g in 1 TUBE	2002-02-22	Active
11523-4338-02	1 TUBE in 1 CARTON (11523-4338-2) / 15 g in 1 TUBE	2002-02-22	Active
11523-4338-04	1 TUBE in 1 CARTON (11523-4338-4) / 30 g in 1 TUBE	2002-02-22	Active

Pack size FAQ

What quantity is in NDC 11523-4338-01?

NDC 11523-4338-01 is listed by the FDA — 1 tube in 1 carton / 12 g in 1 tube.

What NDC number is used to bill for this package of Lotrimin Ultra Athletes Foot Butenafine hydrochloride 1 g/100g Cream?

Bill NDC 11523-4338-01 — the 11-digit billing format is 11523433801. 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)	✓ 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

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 11523-4338-1, 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: 11523-4338-01, written without dashes as 11523433801. 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 11523-4338-01, the first segment (11523) is the labeler code FDA assigned to Bayer Healthcare LLC.; the middle segment (4338) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bayer Healthcare LLC.. 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 2 other package presentations of this same product, including 1 tube (11523-4338-02), 1 tube (11523-4338-04). 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?

Bayer Healthcare LLC. 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 34 words ▾

Uses cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm relieves itching, burning, cracking, and scaling which accompany these conditions

⏱️ Dosage and Administration 119 words ▾

Directions adults and children 12 years and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes : apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. for jock itch and ringworm : apply once a day to affected skin for 2 weeks or as directed by a doctor wash hands after each use children under 12 years: ask a doctor

⚠️ Warnings 76 words ▾

Warnings For external use only Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 22 words ▾

Other information do not use if seal on tube is broken or not visible store between 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 5 words ▾

Active ingredient Butenafine hydrochloride 1%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

🎯 Purpose 2 words ▾

Purpose Antifungal

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

🔗 Related NDC lookups

🧪 All Butenafine Hydrochloride NDCsSame ingredient 🏭 All Bayer labeler NDCsLabeler code 11523 📚 All Benzylamine Antifungal NDCsDrug class

💊 Related drugs in this class

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

Nystatin/Triamcinolone Acet 00168-0081-15 Miconazole Nitrate 00316-0225-15 Gentian Violet 00395-1003-92 Tolnaftate 00536-1315-43

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.