Home › NDC Lookup › Ingredients › Pyrethrum Extract, Piperonyl Butoxide › 53145-0308-04
LIENDREX Pyrethrum extract, Piperonyl Butoxide 4 g/100mL; .3 g/100mL Shampoo, 120 mL — NDC 53145-0308-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LIENDREX Pyrethrum extract, Piperonyl Butoxide 4 g/100mL; .3 g/100mL Shampoo, 120 mL — NDC 53145-308-04 (Billing 53145-0308-04)

by Menper Distributors Inc. · 120 mL in 1 BOTTLE

This is a package of 120 mL of LIENDREX Pyrethrum extract, Piperonyl Butoxide 4 g/100mL; .3 g/100mL Shampoo from Menper Distributors Inc., marketed since Jan 2013 and currently FDA-listed. It is this product's only package size.

NDC 53145-0308-04
🏷️ FDA NDC (as labeled) 53145-308-04 billing pads the product 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

NDC database record

One package, one record: these facts belong to NDC 53145-308-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53145 labeler · 308 product · 04 package
Package marketed since
Jan 1, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5314530804 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53145-308-04
Product NDC 53145-308
11-digit billing NDC 53145030804
RxCUI 1372905
UNII LWK91TU9AH, ZUM06L90GV
Application # M031
SPL Set ID 65f86a0d-0cf7-42f6-84de-4dc9e7791aba
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-01-01
Route TOPICAL
Dosage form SHAMPOO
Substance PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Quick answers
  • RxCUI (RxNorm): 1372905
Why two NDCs? The FDA registers this code as 53145-308-04 — 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 → 53145-0308-04. 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.

Clinical

📖 What it is MedlinePlus · NLM

Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.

Read the full MedlinePlus article ↗
📗 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...
📖 Read our full Pyrethrin and Piperonyl Butoxide Topical guide →

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 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
53145-0308-04 You're viewing this Main listing 120 mL in 1 BOTTLE 2013-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Liendrex 4 g/100mL; .3 g/100mLthis 53145-0308-04 Menper 120 ml — — 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
Jan 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.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII X958PZJ9ON
    A synthetic emulsifier derived from sorbitol and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid or semi-solid formulations, improving texture and consistency.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 795TQP1655
    A synthetic cleaning agent derived from coconut or palm oil. It works as an emulsifier and surfactant to help mix oil and water-based ingredients together in liquid formulations.
  • UNII SLK428451L
    Sodium lauroamphoacetate is a mild cleaning agent derived from coconut oil. It acts as a surfactant and emulsifier in medicines, helping blend water and oil-based ingredients together and improving how the product spreads or dissolves.
  • UNII E827ILX331
    A synthetic detergent derived from tridecyl alcohol and sodium sulfate. It helps dissolve and distribute active ingredients evenly throughout the medicine, functioning as a surfactant and emulsifier in liquid formulations.
  • 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.

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

The official label also statesOTHER INGREDIENTS WATER, PEG-80 SORBITAN LAURATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 80, SODIUM TRIDECETH SULFATE, SODIUM LAUROAMPHOACETATE, SODIUM LAURETH-13 CARBOXYLATE, CITRIC ACID AND TETRASODIUM EDTA.

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

LabelerMenper Distributors Inc.
FDA applicationM031 (OTC MONOGRAPH DRUG)
Labeler code53145
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from Menper Distributors Inc. labeler code 53145

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 ⛔ Contraindications ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

USES: FOR THE TREATMENT OF HEAD, BODY, PUBIC (CRAB) LICE.

⏱️ Dosage and Administration 93 words ▾

DIRECTIONS IMPORTANT: READ WARNINGS AND OTHER INFORMATION BEFORE USING. SHAKE WELL BEFORE USING. USE ON DRY HAIR.

APPLY TO AFFECTED AREA UNTIL ALL HAIR IS THOROUGHLY WET WITH PRODUCT. ALLOW PRODUCT TO REMAIN ON FOR 10 MINUTES BUT NO LONGER. ADD SUFFICIENT WARM WATER TO FORM A LATHER AND SHAMPOO AS USUAL.

RINSE THOROUGHLY. A FINE TOOTH COMB OR SPECIAL LICE/NIT-REMOVAL COMB MAY BE USED TO HELP REMOVE DEAD LICE AND THEIR EGGS (NITS) FROM HAIR. A SECOND TREATMENT MUST BE DONE IN 7 TO 10 DAYS TO KILL ANY NEWLY HATCHED LICE.

⛔ Contraindications 11 words ▾

ALLERGY ALERT: USE WITH CAUTION ON PERSONS WITH ALLERGIC TO RAGWEED.

⚠️ Warnings 5 words ▾

WARNINGS FOR EXTERNAL USE ONLY.

🧪 Active Ingredient 7 words ▾

ACTIVE INGREDIENTS PYRETHINS 0.30% PIPERONYL BUTOXIDE 4%

🧪 Inactive Ingredients 23 words ▾

OTHER INGREDIENTS WATER, PEG-80 SORBITAN LAURATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 80, SODIUM TRIDECETH SULFATE, SODIUM LAUROAMPHOACETATE, SODIUM LAURETH-13 CARBOXYLATE, CITRIC ACID AND TETRASODIUM EDTA.

🎯 Purpose 3 words ▾

PURPOSE LICE TREATMENT

📄 Do Not Use 24 words ▾

DO NOT USE NEAR OR PERMIT CONTACT WITH EYES OR MUCOUS MEMBRANES, SUCH AS INSIDE THE NOSE, MOUTH, OR VAGINA AS IRRITATION MAY OCCURE.

📄 When Using This Product 45 words ▾

WHEN USING THIS PRODUCT KEEP OUT OF EYES WHEN RINSING HAIR. CLOSE EYES TIGHTLY AND DO NOT OPEN UNTIL PRODUCT IS RINSED OUT. PROTECT EYES WITH WASHCLOTH, TOWEL OR OTHER SUITABLE MATERIAL OR BY SIMILAR METHOD. IF PRODUCT GETS INTO EYES, IMMEDIATELY FLUSH WITH WATER.

📄 Stop Use and Ask a Doctor If 20 words ▾

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OR INFECTION IS PRESENT OR DEVELOPS. INFESTED EYEBROWS OR EYELASHES OCCURS.

📄 Keep Out of Reach of Children 18 words ▾

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

📄 Other Information 14 words ▾

OTHER INFORMATION STORAGE: PROTECT FROM FREEZING AND EXCESSIVE HEAT. DO NOT REUSE ORIGINAL CONTAINER.

📄 Package Label / Principal Display Panel 3 words ▾

Linendrex Label Artwork

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

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 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 Menper Distributors Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Menper Distributors 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.
← 53145-0304-04 · Menper 53145-0311-04 · Menper →
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.