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Itch X Benzyl ALCOHOL/PRAMOXINE Hydrochloride 10 g/100g; 1 g/100g Gel, 35.4 g — NDC 00225-0495-33 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Itch X Benzyl ALCOHOL/PRAMOXINE Hydrochloride 10 g/100g; 1 g/100g Gel, 35.4 g — NDC 0225-0495-33 (Billing 00225-0495-33)

by BF ASCHER AND CO INC · 35.4 g in 1 TUBE

This is a package of 35.4 g of Itch X Benzyl ALCOHOL/PRAMOXINE Hydrochloride 10 g/100g; 1 g/100g Gel from BF ASCHER AND CO INC, marketed since Sep 2014 and currently FDA-listed; retail pharmacies pay about $0.0816 per g (NADAC). It is this product's only package size.

NDC 00225-0495-33
🏷️ FDA NDC (as labeled) 0225-0495-33 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0225-0495-33
Product NDC 0225-0495
11-digit billing NDC 00225049533
NCPDP billing unit GM — per gram (weight)
RxCUI 1293632, 1293634
UNII LKG8494WBH, 88AYB867L5
Application # M017
SPL Set ID 03c16d33-8f59-0184-e054-00144ff8d46c
Established class (EPC) Pediculicide
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-19
Route TOPICAL
Dosage form GEL
Substance BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90859902924020
GPI class Itch-X
GCN Seq No 014190
GCN 85140
HICL code 005169
Ingredient (HICL) Pramoxine Hcl/Benzyl Alcohol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3P
Therapeutic class — specific (HIC3) Antipruritics,Topical
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name ITCH-X GEL
FDB brand name Itch-X
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 014190
  • GCN: 85140
  • GPI-14 (Medi-Span): 90859902924020
  • HICL (First Databank): 005169
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1293632
Why two NDCs? The FDA registers this code as 0225-0495-33 — a 4-4-2 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 labeler segment → 00225-0495-33. 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 Pediculicide class.

Pharmacologic class Pediculicide
Drug family (ATC) Other ectoparasiticides, incl. scabicides
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

Label name ITCH-X GEL Ingredient Pramoxine Hcl/Benzyl Alcohol
📖 About the active ingredient: Benzyl Alcohol; Pramoxine Hydrochloride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Benzyl alcohol lotion is used to treat head lice (small insects that attach themselves to the skin) in adults and children 6 months of age and older. It should not be used in children less than 6 months of age. Benzyl alcohol is in a class of medications called pediculicides. It works by killing the lice. Benzyl alcohol lotion will not kill lice eggs, so the medication must be used a second time to kill the lice that may hatch from these eggs.

Read the full MedlinePlus article ↗
🧪 What is this product?

Itch X is a topical gel containing benzyl alcohol and pramoxine hydrochloride, marketed as an over-the-counter monograph product. Benzyl alcohol is commonly used in products meant to treat head lice and similar parasitic infestations of the skin and scalp. Pramoxine hydrochloride is a local anesthetic typically used to reduce itching and discomfort associated with skin irritation. Together, these ingredients are formulated to address itching and related symptoms of lice infestation when applied directly to affected areas.

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.

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 $0.082 $2.89 / 35.4 g
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.
NADAC price history (per g) — tap or hover for the price & month
Oct 2021 Apr 2022 $0.082 $0.082
▼ Down 1% over the last 2 months.
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
00225-0495-33 You're viewing this Main listing 35.4 g in 1 TUBE 2014-09-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Itch X 10 g/100g; 1 g/100gthis 00225-0495-33 BF 35.4 g $0.082 — 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
Sep 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.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII Q4R969U9FR
    A chelating agent derived from ethylenediamine, used in formulations to bind metal ions and prevent oxidation, helping preserve the medicine's stability and potency over time.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 603P14DHEB
    A synthetic antimicrobial chemical used as a preservative in topical and cosmetic formulations. It prevents bacterial and fungal growth in products to maintain stability and safety during storage and use.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 VTK01UQK3G
    Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
  • UNII PA4J9TF5U2
    A synthetic polymer made from styrene and acrylic compounds. It acts as a film-former and binder in tablets and capsules, helping hold ingredients together and control how quickly the medicine releases into your body.
  • 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.

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

The official label also statesInactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, citric acid, diazolidinyl urea, iodopropynyl butylcarbamate, potassium sorbate, SD alcohol 40, sodium benzoate, sodium sulfite, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

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.

Manufacturer & labeler

LabelerBF ASCHER AND CO INC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00225
First marketedSep 2014
Product typeHuman Otc Drug
Portfolio7 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 31 words ▾

Use Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

⏱️ Dosage and Administration 29 words ▾

Directions adults and children 2 years and older - apply to affected area not more than 3 or 4 times daily children under 2 years - consult a physician

⚠️ Warnings 9 words ▾

Warnings For external use only. Avoid contact with eyes.

📦 Storage and Handling 22 words ▾

Other information store at 59°-86° F (15°-30° C) in a dry place mfd. in the USA for B.F. Ascher & Co., Inc.

🧪 Active Ingredient 10 words ▾

Active ingredients......................................Purpose Benzyl alcohol 10%......................................Topical analgesic Pramoxine hydrochloride 1%.......................Topical analgesic

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, citric acid, diazolidinyl urea, iodopropynyl butylcarbamate, potassium sorbate, SD alcohol 40, sodium benzoate, sodium sulfite, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

🎯 Purpose 31 words ▾

Use Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00225-0360-11 · BF 00225-0611-23 · BF →
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.