Lice No More Lice Killing Piperonyl Butoxide, Pyrethrum Extract 4 g/100mL; .33 g/100mL Shampoo
by Weeks & Leo Co., Inc · 1 BOTTLE in 1 CARTON (11383-001-04) / 118 mL in 1 BOTTLE
NDC 11383-0001-04
🏷️ FDA NDC (as labeled)
11383-001-04
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
11383-001-04
Product NDC
11383-001
11-digit billing NDC
11383000104
RxCUI
283219
UNII
LWK91TU9AH, ZUM06L90GV
Application #
M031
SPL Set ID
372819f1-0817-2cd5-e063-6294a90ac5bf
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-07-01
Route
TOPICAL
Dosage form
SHAMPOO
Substance
PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Why two NDCs?
The FDA registers this code as 11383-001-04 — 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 → 11383-0001-04. 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.
🏭 Manufacturer & labeler
LabelerWeeks & Leo Co., Inc
FDA applicationM031 (OTC MONOGRAPH DRUG)
Labeler code11383
First marketedJul 2025
Product typeHuman Otc Drug
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
📗 Our plain-language guide HelloPharmacist
- It treats lice — specifically head lice, pubic (sometimes called crab) lice, and body lice. You apply it directly to the affected area of skin or hair, not take it by mouth. It's n...
- You leave it on for exactly 10 minutes — no longer — then wash it off with warm water and soap or shampoo. And yes, the second treatment 7 to 10 days later is really important. It...
- How long do I leave it on, and do I really need a second treatment?
- Combing is a key part of the treatment. After rinsing, towel-dry your hair and use a fine-tooth lice comb while the hair is still slightly damp. Work through sections starting at t...
Patient education
Supplement & herbal interactions
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.
💬 Questions about Piperonyl Butoxide, Pyrethrum Extract?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
yellow
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 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 896SJ235FN
A synthetic cleanser derived from lauryl alcohol and sulfate chemistry. It helps break down oils and reduce surface tension in liquid formulations, acting as a surfactant to improve mixing and dispersion of ingredients.
-
UNII 0ZNO9PJJ9J
A synthetic ingredient derived from castor oil that has been chemically modified with polyethylene glycol. It acts as a solubilizer and emulsifier to help mix oil-based and water-based components in the medicine.
-
UNII HB1401PQFS
A synthetic polymer used as a thickening agent and film-former. In medicines, it increases viscosity to improve texture and help the product coat surfaces evenly, commonly used in topical liquids and suspensions.
-
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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol
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.
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 |
|---|---|---|---|---|---|---|
| Major Lice Killing .33 g/100mL; 4 g/100mL 00904-7349-20 | Major | 1 bottle | $0.048 | — | Availability likely | — |
| GNP Lice Killing .33 g/100mL; 4 g/100mL 46122-0759-29 | AmerisourceBergen | 1 bottle | $0.048 | — | Availability likely | — |
| Foster and Thrive Lice Killing .33 g/100mL; 4 g/100mL 70677-1184-01 | Strategic | 1 bottle | $0.048 | — | Availability likely | — |
| Walgreens Lice Killing 4 g/100mL; .33 g/100mL 00363-1253-02 | Walgreens | 1 bottle | — | — | FDA listed | — |
| Walgreens Lice Elimination 00363-3255-01 | Walgreens | 1 kit | — | — | FDA listed | — |
| Lice No More Lice Killing 4 g/100mL; .33 g/100mLthis 11383-0001-04 | Weeks | 1 bottle | — | — | FDA listed | — |
| Lice Killing 4 g/100mL; .33 g/100mL 11383-0253-02 | Weeks | 1 bottle | — | — | FDA listed | — |
| Lice Killing 4 g/100mL; .33 g/100mL 11383-0310-02 | Weeks | 1 bottle | — | — | FDA listed | — |
| ABC Lice Killing .33 g/100mL; 4 g/100mL 11383-0312-02 | Weeks | 1 bottle | — | — | FDA listed | — |
| Rite Aid Lice Killing .33 g/100mL; 4 g/100mL 11822-6616-01 | Rite | 1 bottle | — | — | FDA listed | — |
| ZAP Lice Killing 4 g/100mL; .33 g/100mL 24286-0253-04 | DLC | 1 bottle | — | — | FDA listed | — |
| Quita Piojos Lice Killing 4 g/100mL; .33 g/100mL 24286-1253-02 | DLC | 1 bottle | — | — | FDA listed | — |
| Kroger Complete Lice Treatment Kit 30142-0252-01 | The | 1 kit | — | — | FDA listed | — |
| Kroger Lice Killing .33 g/100mL; 4 g/100mL 30142-0253-08 | The | 1 bottle | — | — | FDA listed | — |
| Mata Piojos Lice 4 g/100mL; .33 g/100mL 48201-0006-08 | GRANDALL | 1 bottle | — | — | FDA listed | — |
| GoodSense Lice Killing .33 g/100mL; 4 g/100mL 50804-0253-04 | Perrigo | 1 bottle | — | — | FDA listed | — |
| Discount Drug Mart Lice Killing 4 g/100mL; .33 g/100mL 53943-0253-02 | Discount | 1 bottle | — | — | FDA listed | — |
| Family Wellness Lice Killing .33 g/100mL; 4 g/100mL 55319-0253-08 | Family | 1 bottle | — | — | FDA listed | — |
| El Piojito Lice Killing 4 g/100mL; .33 g/100mL 55758-0253-02 | Pharmadel | 1 bottle | — | — | FDA listed | — |
| Best Choice Lice Killing 4 g/100mL; .33 g/100mL 63941-0253-04 | Valu | 1 bottle | — | — | FDA listed | — |
| Lice Killing 4 g/100mL; .33 g/100mL 68016-0253-04 | PHARMACY | 1 bottle | — | — | FDA listed | — |
| CVS Health Lice Killing 4 g/100mL; .33 g/100mL 69842-0250-04 | CVS | 1 bottle | — | — | FDA listed | — |
| Leader Lice Killing .33 g/100mL; 4 g/100mL 70000-0633-01 | LEADER/ | 1 bottle | — | — | FDA listed | — |
| Herklin Lice Treatment 4 g/100mL; .33 g/100mL 75940-0192-09 | MarcasUSA | 59 ml | — | — | FDA listed | — |
| Topcare Lice Killing .33 g/100mL; 4 g/100mL 76162-0253-08 | Topco | 1 bottle | — | — | FDA listed | — |
| Meijer Lice Killing .33 g/100mL; 4 g/100mL 79481-2530-08 | Meijer, | 1 bottle | — | — | FDA listed | — |
| RID Lice Killing 40 mg/mL; .033 mg/mL 82392-0100-02 | Oystershell | 1 bottle | — | — | FDA listed | — |
| Quality Choice Lice Killing 4 g/100mL; .33 g/100mL 83324-0269-04 | Quality | 1 bottle | — | — | 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
🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.
🔬 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 Piperonyl Butoxide, Pyrethrum Extract — the ingredient across all brands.
Top reported reactions
Reporter sex
Serious outcomes
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 |
|---|---|---|---|
| 11383-0001-04 You're viewing this | 1 BOTTLE in 1 CARTON (11383-001-04) / 118 mL in 1 BOTTLE | 2025-07-01 | Active |
🧭 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
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 11383-001-04, 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: 11383-0001-04, written without dashes as 11383000104. 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 11383-0001-04, the first segment (11383) is the labeler code FDA assigned to Weeks & Leo Co., Inc; the middle segment (0001) 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 Weeks & Leo Co., Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Weeks & Leo Co., 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
treats head, pubic (crab), and body lice
⏱️ Dosage and Administration ▾
Treat apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck. allow product to remain for 10 minutes, but no longer use warm water to form a lather, shampoo, then thoroughly rinse for head lice, towel dry hair and comb out tangles
⚠️ Warnings ▾
For external use only pregnant or breastfeeding allergic to ragweed. May cause breathing difficulty or an asthmatic attack. near eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas. keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, flush with water right away scalp itching or redness may occur breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
🧪 Active Ingredient ▾
Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)
🧪 Inactive Ingredients ▾
ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol
🎯 Purpose ▾
Lice treatment
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.