Home › NDC Lookup › Ingredients › Tioconazole › 63736-0413-01
Monistat Tioconazole 1 6.5 g/100g Ointment, 1 applicator — NDC 63736-0413-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Monistat Tioconazole 1 6.5 g/100g Ointment, 1 applicator — NDC 63736-413-01 (Billing 63736-0413-01)

by Insight Pharmaceuticals LLC · 1 APPLICATOR in 1 CARTON / 4.6 g in 1 APPLICATOR

This is a package of 1 applicator of Monistat Tioconazole 1 6.5 g/100g Ointment from Insight Pharmaceuticals LLC, marketed since Nov 2001 and currently FDA-listed. It is this product's only package size.

NDC 63736-0413-01
🏷️ FDA NDC (as labeled) 63736-413-01 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 17, 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 63736-413-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63736 labeler · 413 product · 01 package
Package marketed since
Nov 21, 2001
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6373641301 9
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63736-413-01
Product NDC 63736-413
11-digit billing NDC 63736041301
RxCUI 198380, 1661176
UNII S57Y5X1117
Application # ANDA075915
SPL Set ID 587e42b4-cbdc-4a03-afae-f9e5e6605937
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 2001-11-21
Route TOPICAL
Dosage form OINTMENT
Substance TIOCONAZOLE
Quick answers
  • RxCUI (RxNorm): 198380
Why two NDCs? The FDA registers this code as 63736-413-01 — 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 → 63736-0413-01. 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

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
63736-0413-01 You're viewing this Main listing 1 APPLICATOR in 1 CARTON / 4.6 g in 1 APPLICATOR 2001-11-21 — 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/100g 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/100gthis 63736-0413-01 Insight 1 applicator — — FDA listed —
basic care tioconazole 6.5 g/100g 72288-0426-54 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

🏛️
2001
On the market since
Nov 2001
📍
2026
Currently FDA-listed
25 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 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

LabelerInsight Pharmaceuticals LLC
Application holderL PERRIGO CO
FDA applicationANDA075915 (ANDA)
Labeler code63736
First marketedNov 2001
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from Insight Pharmaceuticals LLC labeler code 63736

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 🧪 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 5 words ▾

Uses treats vaginal yeast infections

⏱️ Dosage and Administration 65 words ▾

Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years of age and over: ○ open the foil packet just before use and remove purple cap ○ insert entire content 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 diseases (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 in 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).

🧪 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 83 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 59 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 diseases (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 39 words ▾

Stop use and ask a doctor if: symptoms do not get better in 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 11 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 2 words ▾

Questions? 1-877-666-4782

📄 Package Label / Principal Display Panel 19 words ▾

PRINCIPAL DISPLAY PANEL MONISTAT® Tioconazole Ointment 6.5% VAGINAL ANTIFUNGAL Net Wt.

0.16OZ (4.6 g) PREFILLED APPLICATOR Monistat Tioconazole

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

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 MONISTAT TIOCONAZOLE 1 (this brand).

Top reported reactions

Vulvovaginal Burning Sensation523
Vulvovaginal Swelling293
Vulvovaginal Pain227
Condition Aggravated225
Vulvovaginal Pruritus196
Vulvovaginal Discomfort160
Vaginal Discharge59

Age at onset

Adult51
Elderly6

Reporter sex

1,522 reports

Serious outcomes

Hospitalization40
Life-threatening3
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 300 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 Insight Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Insight Pharmaceuticals 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.
← 63736-0378-02 · Insight 63736-0560-18 · Insight →
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.