Leader Anti-Itch Camphor, Menthol .5 g/100g; .5 g/100g Lotion, 212 g
by LEADER/Cardinal Helath 110, Inc. · 212 g in 1 BOTTLE, PUMP (70000-0546-1)
NDC 70000-0546-01
🏷️ FDA NDC (as labeled)
70000-0546-1
billing pads the package 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)
70000-0546-1
Product NDC
70000-0546
11-digit billing NDC
70000054601
NCPDP billing unit
ML — per mL (volume)
UNII
5TJD82A1ET, L7T10EIP3A
Application #
M017
SPL Set ID
9ca985c6-5017-0558-e053-2995a90a8202
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-01-21
Route
TOPICAL
Dosage form
LOTION
Substance
CAMPHOR (SYNTHETIC); MENTHOL
GPI-14
90229902104120
GPI class
Anti-Itch
GCN Seq No
023766
GCN
79831
HICL code
002600
Ingredient (HICL)
Menthol/Camphor
HIC1 code
L
Therapeutic class — broad (HIC1)
Skin/Subcutaneous Tissue
HIC2 code
L6
Therapeutic class — intermediate (HIC2)
Irritants
HIC3 code
L6A
Therapeutic class — specific (HIC3)
Irritants/Counter-Irritants
AHFS code
84:92.00.00
AHFS class
Skin And Mucous Membrane Agents, Misc.
FDB label name
ANTI-ITCH 0.5%-0.5% LOTION
FDB brand name
Anti-Itch
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0546-1 — a 5-4-1 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 package segment → 70000-0546-01. 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
LabelerLEADER/Cardinal Helath 110, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2020
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
Label name ANTI-ITCH 0.5%-0.5% LOTION Ingredient Menthol/Camphor
🧪 What is this product?
Leader Anti-Itch Camphor, Menthol is a topical lotion marketed as an over-the-counter monograph drug. It contains camphor and menthol, both of which are typically used as topical counterirritants and cooling agents. These ingredients are commonly included in products meant to provide temporary relief of minor itching and skin irritation when applied to the affected area.
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 Camphor, Menthol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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 59TL3WG5CO
A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
-
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 BYR0546TOW
DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
-
UNII FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
-
UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
-
UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
-
UNII ECU18C66Q7
PEG-40 stearate is a synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves and is absorbed.
-
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarbomer interpolymer type A, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.022 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.0354 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 12% over the last 19 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Anti-Itch .5 g/100g; .5 g/100g 00536-1268-12 | RUGBY | 212 g | $0.022 | — | Availability likely | — |
| GNP Anti Itch .5 g/100g; .5 g/100g 46122-0573-10 | AMERISOURCEBERGEN | 212 g | $0.022 | — | Availability likely | — |
| Leader Anti-Itch .5 g/100g; .5 g/100gthis 70000-0546-01 | LEADER/Cardinal | 212 g | $0.022 | — | Availability likely | — |
| Walgreen Anti Itch .5 g/100g; .5 g/100g 00363-4262-75 | Walgreens | 212 g | — | — | FDA listed | — |
| Discount Drug Mart Anti-Itch .5 g/100g; .5 g/100g 53943-0262-75 | Discount | 212 g | — | — | FDA listed | — |
| CVS Anti-Itch .5 g/100g; .5 g/100g 69842-0626-75 | CVS | 212 g | — | — | 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
🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0546-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
80
Units reimbursed last 4 qtrs
17.8K
Gross reimbursed last 4 qtrs
$629.43
Avg / prescription
$7.87
Avg / unit
$0.0354
Latest quarter Q1 2026
17Rx
Medicaid pays / mL
$0.0354
gross reimbursed
vs
NADAC / mL
$0.0222
acquisition cost
=
Spread
+$0.0132
+59% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 80 Rx
State Medicaid map
Units reimbursed · per 100k residents
26.3267
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 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 Leader Anti-Itch (this brand).
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 |
|---|---|---|---|
| 70000-0546-01 You're viewing this | 212 g in 1 BOTTLE, PUMP (70000-0546-1) | 2020-01-21 | Active |
📄 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 ▾
temporary relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac
⏱️ Dosage and Administration ▾
Directions to open, squeeze cap tightly and turn pump counter-clockwise adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor
⚠️ Warnings ▾
For external use only on chicken pox on measles do not get into eyes condition worsens symptoms last more than 7 days or clear up and occur again within a few days If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information store at 20 °C to 25 °C (68 °F to 77 °F)
🧪 Active Ingredient ▾
Camphor 0.5% Menthol 0.5%
🧪 Inactive Ingredients ▾
carbomer interpolymer type A, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum
🎯 Purpose ▾
Anti-itch External Analgesic
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.