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Leader Tioconazole 1 6.5 g/100g Ointment, 1 applicator — NDC 70000-0357-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Leader Tioconazole 1 6.5 g/100g Ointment, 1 applicator — NDC 70000-0357-1 (Billing 70000-0357-01)

by Cardinal Health 110, LLC. dba Leader · 1 APPLICATOR in 1 CARTON / 4.6 g in 1 APPLICATOR

This is a package of 1 applicator of Leader Tioconazole 1 6.5 g/100g Ointment from Cardinal Health 110, LLC. dba Leader, marketed since Apr 2018 and currently FDA-listed; retail pharmacies pay about $2.41 per g (NADAC). It is this product's only package size.

NDC 70000-0357-01
🏷️ FDA NDC (as labeled) 70000-0357-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 70000-0357-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0357 product · 1 package
Package marketed since
Apr 20, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7000003571 6
Medicaid fills, this package
13 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0357-1
Product NDC 70000-0357
11-digit billing NDC 70000035701
NCPDP billing unit GM — per gram (weight)
RxCUI 198380
UNII S57Y5X1117
Application # ANDA075915
SPL Set ID 6db31d83-acd7-4e4e-8f98-fe46102a6832
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-04-20
Route VAGINAL
Dosage form OINTMENT
Substance TIOCONAZOLE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 55104075004220
GPI class Tioconazole-1
GCN Seq No 012092
GCN 05280
HICL code 004569
Ingredient (HICL) Tioconazole
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q4
Therapeutic class — intermediate (HIC2) Vaginal Preparations
HIC3 code Q4F
Therapeutic class — specific (HIC3) Vaginal Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name TIOCONAZOLE-1 6.5% OINTMENT
FDB brand name Tioconazole-1
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 012092
  • GCN: 05280
  • GPI-14 (Medi-Span): 55104075004220
  • HICL (First Databank): 004569
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 198380
Why two NDCs? The FDA registers this code as 70000-0357-1 — 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 → 70000-0357-01. 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.

RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Imidazole derivatives
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.

Clinical

Label name TIOCONAZOLE-1 6.5% OINTMENT Ingredient Tioconazole
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 $2.409 $11.08 / 4.6 g
Medicaid paysCMS SDUD · 12 mo $2.42 $11.15 / 4.6 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Nov 2022 Mar 2026 Sep 2026 $2.521 $2.190
▲ Up 7% over the last 17 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70000-0357-01 You're viewing this Main listing 1 APPLICATOR in 1 CARTON / 4.6 g in 1 APPLICATOR 2018-04-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense tioconazole 1 6.5 g/100g 00113-0426-54 L. 1 pouch $2.409 — Availability likely —
Leader Tioconazole 1 6.5 g/100gthis 70000-0357-01 Cardinal 1 applicator $2.409 — Availability likely —
foster and thrive tioconazole 6.5 g/100g 70677-1224-01 Strategic 1 applicator $2.409 — Availability likely —
Tioconazole 1 6.5 g/100g 00363-0426-54 Walgreen 1 pouch — — FDA listed —
Vagistat 6.5 g/100g 11509-0426-01 Combe 1 pouch — — FDA listed —
Up and up tioconazole 1 6.5 g/100g 11673-0426-54 Target 1 pouch — — FDA listed —
signature care tioconazole 1 6.5 g/100g 21130-0060-54 Safeway 1 pouch — — FDA listed —
Tioconazole 1 6.5 g/100g 21130-0781-54 Safeway 1 pouch — — FDA listed —
Topcare Tioconazole 1 6.5 g/100g 36800-0426-54 Topco 1 pouch — — FDA listed —
Tioconazole 1 6.5 g/100g 37808-0426-54 H 1 pouch — — FDA listed —
Equaline Tioconazole 1 6.5 g/100g 41163-0032-54 United 1 pouch — — FDA listed —
tioconazole 1 6.5 g/100g 41250-0426-54 Meijer 1 pouch — — FDA listed —
CareOne Tioconazole 1 6.5 g/100g 41520-0426-54 American 1 pouch — — FDA listed —
Equate tioconazole 1 day 6.5 g/100g 49035-0426-54 Wal-Mart 1 pouch — — FDA listed —
dg health tioconazole 1 6.5 g/100g 55910-0731-54 Dolgencorp 1 pouch — — FDA listed —
tioconazole 1 6.5 g/100g 59779-0718-26 CVS 1 pouch — — FDA listed —
Monistat Tioconazole 1 6.5 g/100g 63736-0413-01 Insight 1 applicator — — FDA listed —
basic care tioconazole 6.5 g/100g 72288-0426-54 Amazon.com 1 pouch — — FDA listed —
Tioconazole 1 6.5 g/100g 72288-0222-54 Amazon.com 1 pouch — — 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color Brown
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 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 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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.

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

The official label also statesbutylated hydroxyanisole, magnesium aluminum silicate, 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.

Manufacturer & labeler

LabelerCardinal Health 110, LLC. dba Leader
Application holderL PERRIGO CO
FDA applicationANDA075915 (ANDA)
Labeler code70000
First marketedApr 2018
Product typeHuman Otc Drug
Portfolio163 products on file

More NDCs from Cardinal Health 110, LLC. dba Leader labeler code 70000

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 6 words ▾

Use • treats vaginal yeast infections

⏱️ Dosage and Administration 68 words ▾

Directions • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed packet just before use and remove purple cap • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. • children under 12 years of age: ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS When using this product • do not use tampons, douches, spermicides, or other vaginal products.

Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if • symptoms do not get better after 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge 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 76 words ▾

Other information • this product is a 1-dose treatment. Most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. • if you have questions about vaginal yeast infections, consult your doctor • store at 20 ° -25 ° C (68 ° -77 ° F) • see end flap of carton for lot number and expiration date

🧪 Active Ingredient 9 words ▾

Active ingredient (in each applicator) Tioconazole 300 mg (6.5%)

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

🎯 Purpose 3 words ▾

Purpose Vaginal antifungal

📄 Do Not Use 16 words ▾

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

📄 Ask a Doctor Before Use If 87 words ▾

Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

📄 When Using This Product 63 words ▾

When using this product • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if • symptoms do not get better after 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

🤰 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? 1-800-719-9260

📄 Package Label / Principal Display Panel 45 words ▾

Principal Display Panel LEADER ™ Tioconazole 1 Tioconazole Ointment 6.5% Vaginal Antifungal Cures Most Vaginal Yeast Infections Odorless Formula 1 Pre-Filled Applicator 1-Dose Treatment Educational Brochure Enclosed COMPARE TO MONISTAT® 1 active ingredient 100% Money Back Guarantee NET WT 4.6 g (0.16 OZ) ticoconazole-1-carton-image-1 ticoconazole-1-carton-image-2

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

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 this package alone, 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
13
Units reimbursed last 4 qtrs
87
Gross reimbursed last 4 qtrs
$210.90
Avg / prescription
$16.22
Avg / unit
$2.4130
Latest quarter Q1 2026
0Rx
Medicaid pays / g
$2.4130
gross reimbursed
vs
NADAC / g
$2.4089
acquisition cost
=
Spread
+$0.0041
+0% vs cost
What Medicaid paid per g (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 ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 13 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 87 units · 0.7 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.70.7
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
🏆 Top states by units · per 100k residents
1 Pennsylvania 0.7 /100k
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 Tioconazole 1 (this brand).

Top reported reactions

Vulvovaginal Burning Sensation518
Vulvovaginal Swelling290
Condition Aggravated225
Vulvovaginal Pain224
Vulvovaginal Pruritus195
Vulvovaginal Discomfort160
Vaginal Discharge59

Age at onset

Adult49
Elderly6

Reporter sex

1,512 reports
Male · 2%
Female · 98%
Unknown · 0%

Serious outcomes

Hospitalization39
Life-threatening2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 299 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.
← 70000-0348-01 · CARDINAL 70000-0358-01 · Cardinal →
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.