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Ivermectin 5 mg/g Lotion — NDC 51316-0985-08 package photo

Ivermectin 5 mg/g Lotion

by CVS Pharmacy · 1 TUBE in 1 CARTON (51316-985-08) / 117 g in 1 TUBE
NDC 51316-0985-08
🏷️ FDA NDC (as labeled) 51316-985-08 billing pads the product segment with a zero
OTC Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 51316-985-08
Product NDC 51316-985
11-digit billing NDC 51316098508
RxCUI 1246673
UNII 8883YP2R6D
Application # ANDA210720
SPL Set ID 326e85c6-b95f-6aa8-e063-6294a90a4985
Established class (EPC) Antiparasitic; Pediculicide
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-20
Route TOPICAL
Dosage form LOTION
Substance IVERMECTIN
Why two NDCs? The FDA registers this code as 51316-985-08 — 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 → 51316-0985-08. 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 Antiparasitic class.

Pharmacologic class Antiparasitic, Pediculicide
Drug family (ATC) Other dermatologicals, Avermectines
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

LabelerCVS Pharmacy
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA210720 (ANDA)
Labeler code51316
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio550 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Ivermectin lotion is used to treat head lice (small bugs that attach themselves to the skin) in adults and children 6 months of age and older. Ivermectin is in a class of medications called anthelmintics. It works by killing lice.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's important to use ivermectin only for the condition your doctor prescribed it for. The tablet form is approved for two specific parasitic infections — strongyloidiasis and onch...
  • Can I use ivermectin for anything other than what my doctor prescribed it for?
  • Ivermectin tablets should be taken on an empty stomach with a full glass of water. Eating a high-fat meal around the time of your dose can increase the amount your body absorbs by...
  • Should I take the ivermectin tablet with food or on an empty stomach?
📖 Read our full Ivermectin guide →
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 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 RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • 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 NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • 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 M629807ATL
    Imidazolidinyl urea is a synthetic preservative that prevents microbial growth in medicines. It's used in formulations to extend shelf life and maintain product safety during storage.
  • UNII 884C3FA9HE
    Lanolin alcohol is a waxy substance derived from sheep's wool. It functions as an emollient and emulsifier in medicines, helping blend oil and water-based ingredients while softening the product's texture.
  • 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 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • 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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 6LUM696811
    A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.

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

The official label also statesbutylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl 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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sklice 5 mg/g 24338-0185-04 Azurity 1 tube $0.286 — Availability likely —
Ivermectin 5 mg/g 51672-4230-08 Sun 1 tube $1.232 — Availability likely —
Ivermectin 5 mg/g 00363-4230-08 Walgreen 1 tube — — FDA listed —
Ivermectin 5 mg/g 11822-4230-08 Rite 1 tube — — FDA listed —
Ivermectin 5 mg/g 27854-0334-01 Belmora 1 tube — — FDA listed —
Ivermectin 5 mg/g 46122-0827-36 AmerisourceBergen 1 tube — — FDA listed —
Ivermectin 5 mg/g 51316-0423-08 CVS 1 tube — — FDA listed —
Ivermectin 5 mg/gthis 51316-0985-08 CVS 1 tube — — FDA listed —
Ivermectin 5 mg/g 79903-0154-01 WALMART 1 tube — — FDA listed —
RID One and Done 5 mg/g 82392-0200-04 Oystershell 1 tube — — FDA listed —
lice treatment dedicated .5 g/100g 87276-0000-01 Shenzhen 1 g — — FDA listed —
lice treatment dedicated .5 g/100g 87276-0001-01 Shenzhen 1 g — — Discontinued —
ivometn ivermectin lice treatment .5 g/100g 87276-0003-01 Shenzhen 1 g — — FDA listed —
SYNTHABIO Ivermectin .5 g/100g 87782-0001-02 Shenzhen 1 tube — — FDA listed —
Ivermectin 5 mg/g 24338-0119-45 Azurity 1 tube — — FDA listed —
Ivermectin 5 mg/g 73581-0021-04 YYBA 1 tube — — 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

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

Medicare Part D (outpatient prescription) spending for IVermectin — the program that covers self-administered drugs. 7 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 IVermectin. 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
$3.22M
Claims incl. refills
25.2K
Beneficiaries
20.3K
Spend / beneficiary
$158.78
Spend / claim
$128.08
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 Ivermectin — the ingredient across all brands.

Top reported reactions

Headache647
Asthenia590
Pyrexia485
Pruritus388
Diarrhoea292
Ocular Hyperaemia257
Coma245

Age at onset

Neonate1
Infant3
Child30
Adolescent14
Adult454
Elderly210

Reporter sex

6,298 reports
Male · 46%
Female · 53%
Unknown · 1%

Serious outcomes

Hospitalization2,223
Death565
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 626 347
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 NDCDescription Marketing startStatus
51316-0985-08 You're viewing this 1 TUBE in 1 CARTON (51316-985-08) / 117 g in 1 TUBE 2025-06-20 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

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 51316-985-08, 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: 51316-0985-08, written without dashes as 51316098508. 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 51316-0985-08, the first segment (51316) is the labeler code FDA assigned to CVS Pharmacy; the middle segment (0985) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 CVS Pharmacy. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Pharmacy 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 4 words ▾

Use treats head lice

⏱️ Dosage and Administration ~2 min read ▾

Directions Important: Read warnings before use children 6 months of age to under 12 years of age: an adult should supervise use adults and children 6 months of age and over: 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/or 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 examine small sections of the hair (1-2 inches wide) 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 product Treat your hair and scalp must be DRY before applying product use the top of cap to break the tamper seal on the tube apply product directly to dry hair and scalp completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair use only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remaining rub product throughout your hair it is important to completely cover your entire head so that all lice and eggs are exposed to the lotion.

Be sure that each hair is coated from the scalp to the tip. Wait and rinse allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock.

Start timing after you have completely covered your hair and scalp with product. after 10 minutes, rinse product completely from your hair and scalp using only water after rinsing, dry and style as usual. Wait 24 hours before applying shampoo. After treatment wash your hands after applying product nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nits this is a single use product.

Discard tube after use. do not use again on the same person and same lice infestation without talking to a healthcare provider first if infestation continues, see a doctor for other treatments machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes. after finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice.

⚠️ Warnings 192 words ▾

Warnings For external use only. Use only on the scalp. Do not use on children under 6 months of age near the eyes inside the nose, ear, mouth, or vagina on lice in eyebrows or eyelashes.

See a doctor if lice are present in these areas. Ask a doctor before use if you have any skin conditions or sensitivities are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby. are currently or planning to breastfeed.

Avoid getting product on your breast to help prevent contact by your baby. When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, gently flush with water eye redness, soreness, or irritation can occur dandruff, dry skin, or burning sensation of the skin can occur Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs rash develops If pregnant or breastfeeding, ask a health professional before use.

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

📦 Storage and Handling 37 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN. store at room temperature 68º-77ºF (20º-25ºC) do not freeze keep carton and see Consumer Information Leaflet and warnings before use

🧪 Active Ingredient 4 words ▾

Active ingredient Ivermectin 0.5%

🧪 Inactive Ingredients 38 words ▾

Inactive ingredients butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.

🎯 Purpose 3 words ▾

Purpose Lice treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51316-0984-03 · CVS 51316-0987-01 · CVS →
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.