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Topcare lice killing creme rinse Permethrin 1 mg/100mL Lotion — NDC 36800-0629-26 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Topcare lice killing creme rinse Permethrin 1 mg/100mL Lotion — NDC 36800-629-26 (Billing 36800-0629-26)

by Topco Associates LLC · 2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE

This is a package of Topcare lice killing creme rinse Permethrin 1 mg/100mL Lotion from Topco Associates LLC, marketed since Jan 2020 and currently FDA-listed. It is this product's only package size.

NDC 36800-0629-26
🏷️ FDA NDC (as labeled) 36800-629-26 billing pads the product segment with a zero
OTC Generic 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 36800-629-26 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
36800 labeler · 629 product · 26 package
Package marketed since
Jan 31, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3680062926 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-629-26
Product NDC 36800-629
11-digit billing NDC 36800062926
UNII 509F88P9SZ
Application # ANDA076090
SPL Set ID 3b4146a6-7c54-4dd0-9388-1e38491d16f3
Established class (EPC) Pyrethroid
Chemical class Pyrethrins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-31
Route TOPICAL
Dosage form LOTION
Substance PERMETHRIN
Why two NDCs? The FDA registers this code as 36800-629-26 — 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 → 36800-0629-26. 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

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
36800-0629-26 You're viewing this Main listing 2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE 2020-01-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense lice killing creme rinse 1 mg/100mL 00113-1910-16 L. 1 bottle $0.112 — FDA listed —
Topcare lice killing creme rinse 1 mg/100mLthis 36800-0629-26 Topco 2 bottles — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 H1TFV1454Z
    Balsam fir leafy twig is a plant extract from the evergreen balsam fir tree. It's used in medicines as a flavoring agent and fragrance to improve taste or smell.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII LF9X1PN3XJ
    A synthetic ingredient derived from cetyl alcohol and ethylene oxide. It works as an emulsifier and surfactant to help mix oil and water-based components, keeping the medicine uniform and stable.
  • 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 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 0OUO26BB88
    A compound derived from stearyl alcohol that acts as an antistatic agent and emulsifier. It reduces static electricity in the powder and helps blend water and oil components together in the formulation.
  • 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 statesabies balsamea (balsam canada) extract, anhydrous citric acid, butylparaben, ceteth-10, cetyl alcohol, ethylparaben, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose, isopropyl alcohol, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearalkonium chloride

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

LabelerTopco Associates LLC
Application holderPERRIGO NEW YORK INC
FDA applicationANDA076090 (ANDA)
Labeler code36800
First marketedJan 2020
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 36800

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

Use treats head lice

⏱️ Dosage and Administration ~2 min read ▾

Directions Inspect • all household members should be checked by another person for lice and/or nits (eggs) • use a magnifying glass in bright light to help you see the lice and nits (eggs) • use a tool, such as a comb or two unsharpened pencils to lift and part the hair • look for tiny nits near the scalp, beginning at the back of the neck and behind the ears • small sections of hair (1-2 inches wide) should be examined at a time • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. • if either lice or nits (eggs) are found, treat with the creme rinse Treat • wash hair with a shampoo without conditioner.

Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of the creme rinse. Rinse with water. • towel dry hair so it is damp but not wet • shake the bottle well • completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck. • keep the creme rinse out of the eyes.

Protect the eyes with a washcloth or towel. • leave the creme rinse on the hair for 10 minutes, but no longer • rinse with warm water • towel dry hair and comb out tangles • if live lice are seen seven days or more after the first treatment, a second treatment should be given Remove Lice/Nits • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out. • use the nit comb provided and make sure the hair remains slightly damp while removing nits • if the hair dries during combing, dampen it slightly with water • part the hair into 4 sections.

Work on one section at a time. Longer hair may take more time (1-2 hours). • start at the top of the head on the section you have picked • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair. • use clips to pin back each strand of hair after you have combed out the nits • clean the comb completely as you go.

Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back. • after combing, recheck the entire head for nits and repeat combing if necessary • check the affected head daily to remove any nits that you might have missed

⚠️ Warnings 150 words ▾

Warnings For external use only Do not use • on children under 2 months of age • near the eyes • inside the nose, ear, mouth, or vagina • on lice in eyebrows or eyelashes. See your doctor. Ask a doctor before use if you are • allergic to ragweed.

May cause breathing difficulty or an asthmatic episode. When using this product • keep eyes tightly closed and protect eyes with a washcloth or towel • if product gets into the eyes, immediately flush with large amounts of water • scalp itching or redness may occur Stop use and see a doctor if • breathing difficulty occurs • eye irritation occurs • skin or scalp irritation continues or infection occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📦 Storage and Handling 32 words ▾

Other information • read all the directions and warnings in the Consumer Information Insert before use. Keep the carton. It contains important information. • store at 20 to 25°C (68 to 77°F)

🧪 Active Ingredient 10 words ▾

Active ingredient (in each fluid ounce) Permethrin 280 mg (1%)

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients abies balsamea (balsam canada) extract, anhydrous citric acid, butylparaben, ceteth-10, cetyl alcohol, ethylparaben, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose, isopropyl alcohol, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearalkonium chloride

🎯 Purpose 3 words ▾

Purpose Lice treatment

📄 Do Not Use 33 words ▾

Do not use • on children under 2 months of age • near the eyes • inside the nose, ear, mouth, or vagina • on lice in eyebrows or eyelashes. See your doctor.

📄 Ask a Doctor Before Use If 20 words ▾

Ask a doctor before use if you are • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

📄 When Using This Product 38 words ▾

When using this product • keep eyes tightly closed and protect eyes with a washcloth or towel • if product gets into the eyes, immediately flush with large amounts of water • scalp itching or redness may occur

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and see a doctor if • breathing difficulty occurs • eye irritation occurs • skin or scalp irritation continues or infection occurs

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 76 words ▾

Package/Label Principal Display Panel FAMILY PACK COMPARE TO NIX ® CREME RINSE ACTIVE INGREDIENT Lice Killing Creme Rinse PERMETHRIN LOTION1% - LICE TREATMENT WITH A SINGLE APPLICATION: Kills Lice & Their Eggs Prevents Reinfestation for 14 Days SAFE: Approved for use on Children Over 2 Months of Age INCLUDES: 2 BOTTLES CREME RINSE – 2 FL OZ (59 mL) EACH 2 NIT REMOVAL COMBS lice killing creme rinse image 1 lice killing creme rinse image 2

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Permethrin (matched by generic name) — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Permethrin. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.72M
Claims incl. refills
46.1K
Beneficiaries
34.9K
Spend / beneficiary
$49.33
Spend / claim
$37.35
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Topcare lice killing creme rinse (this brand).

Top reported reactions

Pruritus96
Pain83
Chronic Kidney Disease66
Anxiety63
Nausea54
Rash54
Dry Skin52

Age at onset

Neonate1
Child10
Adolescent3
Adult187
Elderly64

Reporter sex

1,281 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization209
Life-threatening29
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 148 0
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.

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 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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates 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.
← 36800-0628-02 · TOPCO 36800-0632-01 · TOPCO →
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.