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Smooth Gator Fungus Eliminator CLOTRIMAZOLE 10 mg/mL Liquid, 59 mL — NDC 70673-0747-01 package photo

Smooth Gator Fungus Eliminator CLOTRIMAZOLE 10 mg/mL Liquid, 59 mL

by Smooth Gator, LLC · 59 mL in 1 BOTTLE (70673-747-01)
NDC 70673-0747-01
🏷️ FDA NDC (as labeled) 70673-747-01 billing pads the product 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Clotrimazole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0210-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0211-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70673-747-01
Product NDC 70673-747
11-digit billing NDC 70673074701
RxCUI 309370
UNII G07GZ97H65
UPC 0001201000066
Application # M005
SPL Set ID 262b04f5-1b5d-4c67-a557-01f8b1711302
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-29
Route TOPICAL
Dosage form LIQUID
Substance CLOTRIMAZOLE
Why two NDCs? The FDA registers this code as 70673-747-01 — 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 → 70673-0747-01. 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) Antiinfectives and antiseptics for local oral treatment, 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.

🏭 Manufacturer & labeler

LabelerSmooth Gator, LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code70673
First marketedApr 2016
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

📖 What it is MedlinePlus · NLM

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on which product you have. The topical creams, solutions, and sprays treat common fungal skin infections — athlete's foot, jock itch, and ringworm. The CLOTIC ear drops...
  • What kinds of infections does clotrimazole actually treat?
  • You may start to notice some relief within a few days, but it's important to finish the full course. For athlete's foot and ringworm, that means using it every day for 4 weeks. For...
  • How long do I need to use it before it starts working?
📖 Read our full Clotrimazole 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.

🧪 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 344821WD61
    Emu oil is a natural fat derived from emu birds, used in some medicines as an emollient and penetration enhancer to help active ingredients absorb through the skin and soften the formulation.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII XO45V955LT
    A natural oil extract from olives that contains compounds resistant to saponification. Used as an emollient and skin-conditioning agent to improve product texture and spreadability in topical formulations.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 4VBL71TY4Y
    Safflower is a plant-derived ingredient used as a natural colorant and flavoring agent in medicines. It may also serve as a filler to add bulk to the formulation.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.

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

The official label also statesBHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

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 mLPer 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
Clotrimazole 10 mg/mL 51672-1260-03 Sun 1 bottle $0.442 AT Availability likely —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 TruPharma 1 bottle $0.442 AT Availability likely —
Clotrimazole 10 mg/mL 70954-0036-20 Novitium 1 bottle $0.442 AT Availability likely —
Clotrimazole 1 g/mL 00536-1181-70 RUGBY 10 ml $2.371 — FDA listed —
Clotrimazole 1 g/100mL 00536-1443-70 Rugby 1 bottle $2.376 — Availability likely —
Clotrimazole 1 g/mL 51672-2158-01 Sun 1 bottle $2.376 — Availability likely —
Clotrimazole 1 g/mL 70010-0229-54 Granules 10 ml $2.376 — Availability likely —
Clotrimazole (Topical Solution), 1% 10 mg/mL 83474-0003-34 Puro 1 bottle $2.376 — Availability likely —
Clotrimazole 1 g/mL 10135-0671-81 Marlex 1 bottle — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 ScieGen 1 bottle — AT FDA listed —
Clotrimazole 1 g/mL 50268-0044-30 AvPAK 1 bottle — — FDA listed —
Fungicure Intensive 10 mg/mL 52389-0600-60 Kobayashi 1 bottle — — FDA listed —
Fortinia OF 1 g/100mL 54633-0017-01 The 29.57 ml — — FDA listed —
Clotrimazole 1 g/mL 54633-0018-10 The 1 bottle — — FDA listed —
Fortinia Ultra 1 g/100mL 54633-0025-15 The 15 ml — — FDA listed —
Fortinia 1 g/100mL 54633-0214-01 The 29.57 ml — — FDA listed —
Lasolex Liquid Solution 10 mg/mL 59088-0251-03 PureTek 30 ml — — FDA listed —
Clotrimazole 1 g/mL 68788-4080-01 Preferred 10 ml — — FDA listed —
Clotrimazole Antifungal 10 g/L 69396-0143-33 Trifecta 1 bottle — — FDA listed —
Akin Anti-Fungal 10 mg/mL 69822-0254-05 Southern 1 bottle — — FDA listed —
Smooth Gator Fungus Eliminator 10 mg/mLthis 70673-0747-01 Smooth 59 ml — — FDA listed —
Clotrimazole 1 g/mL 70795-8020-01 GRAXCELL 10 ml — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 71297-0030-02 Allegis 2 bottles — AT FDA listed —
Clotrimazole 1 g/mL 71399-0500-01 Akron 10 ml — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 71399-0666-03 Akron 1 bottle — AT FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 72162-2178-03 Bryant 1 bottle — AT FDA listed —
WELMATE Clotrimazole Topical Solution 10 mg/mL 73581-0449-00 YYBA 1 bottle — — FDA listed —
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution 10 mg/mL 83004-0042-01 Rida 3 bottles — — FDA listed —
Clotrimazole 10 mg/mL 68788-4155-03 Preferred 1 bottle — AT 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

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Clotrimazole (matched by generic name) — the program that covers self-administered drugs. 13 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 Clotrimazole. 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
$6.43M
Claims incl. refills
276K
Beneficiaries
207.9K
Spend / beneficiary
$30.91
Spend / claim
$23.28
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 Smooth Gator Fungus Eliminator (this brand).

Top reported reactions

Macular Degeneration812
Nausea811
Pain777
Headache735
Dyspnoea706
Fatigue641
Diarrhoea598

Age at onset

Neonate46
Infant16
Child33
Adolescent23
Adult1,078
Elderly891

Reporter sex

11,491 reports
Male · 34%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization3,956
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,034 388
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
70673-0747-01 You're viewing this 59 mL in 1 BOTTLE (70673-747-01) 2016-04-29 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 70673-747-01, 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: 70673-0747-01, written without dashes as 70673074701. 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 70673-0747-01, the first segment (70673) is the labeler code FDA assigned to Smooth Gator, LLC; the middle segment (0747) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Smooth Gator, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Smooth Gator, 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.

📄 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
🎯 Indications and Usage 44 words ▾

Uses: For the cure of most • athlete’s foot (tinea pedis) • ringworm (tinea corporis) • jock itch (tinea cruris) For relief of • itching • scaling • cracking • burning • redness • soreness • irritation • discomforts which may accompany these conditions.

⏱️ Dosage and Administration 139 words ▾

Directions: Read all package directions and warnings before using. • Use only as directed. • Clean the affected area with soap and warm water and dry thoroughly. • Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor. • Avoid applying to severely cracked or irritated areas. • For athlete’s foot: pay special attention to spaces between toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. • For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. • Supervise children in the use of this product. • Intended for use by normally healthy adults only. • Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.

⚠️ Warnings 64 words ▾

Warnings: For external use only. Ask a doctor before use on children under 2 years of age. When using this product avoid contact with eyes. Stop use and ask doctor if Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch). KEEP OUT OF RICH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately

🧪 Active Ingredient 7 words ▾

Active ingredients: Clotrimazole 1.00% Purpose: Antifungal Treatment

🧪 Inactive Ingredients 47 words ▾

Inactive ingredients: BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).

🎯 Purpose 3 words ▾

Purpose: Antifungal Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70673-0501-00 · Smooth 70677-0001-01 · Strategic →
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.